[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Central Institute of Mental Health, Mannheim\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":266},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,43,73,99,129,164,186,210,236],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100581039","phase-2-a-trial-to-investigate-the-effects-of-cannabidiol-plus-naltrexone-on-alcohol-craving-in-patients-with-alcohol-dependence-100581039",false,"NCT06845124","A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence","ICONICplus - Randomized, Double-blind, Placebo-controlled Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Cue-Induced Alcohol Craving in Alcohol Dependence","ICONICplus","Inclusion Criteria:\n\n* Age between 18 and 70 years\n* Patients meeting the diagnosis of an alcohol dependence according to the ICD-10\n* Patients reporting alcohol craving as symptom of AD according to the ICD10 symptom definition\n* Ability of subject to understand character and individual consequences of the clinical trial\n* Written informed consent (must be available before enrollment in the study)\n* Consent to random assignment\n* For women with childbearing potential (WOCBP) and males with partners with CBP, use of a highly effective birth control method until one month after last IMP administration (see Appendix 1) and negative pregnancy test\n\nExclusion Criteria:\n\n* Current psychotic or bipolar disorder or current severe depressive episode with suicidal ideations\n* Current treatment with any of the following substances: Any investigational medicinal product, Opioid-containing Analgesics, Anti-obesity drugs, Anticonvulsants, Opioid-containing Antidiarrheal Agents, Antineoplastics, Antipsychotics (exception: episodic use of melperone, prothipendyl, pipamperone, promethazine and quetiapine are allowed), Antidepressants (exception: allowed, when being taken in stable dose for a minimum of 14 days prior to enrolment and\u002For doxepine in low doses \\[max. 75mg daily\\]), Opioid-containing Cough\u002Fcold agents, Systemical Steroids, Other anti-craving (e.g. Acamprosate) or aversive medication (e.g. disulfiram), THC- or CBD-containing medication, Antiretroviral medication (e.g., Efavirenz), Xanthines (e.g., Theophylline), General anesthetics (e.g., propofol), Hypericum perforatum, Antibiotics (e.g., Rifampin, Clarithromycin, Erythromycin)\n* Positive drug screening (amphetamines\u002Fecstasy, opiates, cocaine, barbiturates)\n* Pregnancy, lactation or breastfeeding\n* Current severe somatic comorbidities: severe liver cirrhosis \\[CHILD B or C\\] or epilepsy determined by medical history\n* Patients with elevated transaminase levels (AST or ALT) above three times the upper limit normal (ULN) value with elevated bilirubin levels above twice the ULN value\n* History of hypersensitivity to the investigational medicinal product CBD and\u002For Naltrexone (trade names: Adepend, Naltrexon-Hcl neuraxpharm, Naltrexonhydrochlorid Accord) or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product CBD and\u002For Naltrexone\n* Participation in other clinical trials or observation period of competing clinical trials, respectively.\n* Acute suicidal tendency or acute endangerment of self and others","ALL","18 Years","70 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Alcohol addiction (AD) is a chronic relapsing disorder with currently limited pharmacological treatment options. Alcohol craving, a hallmark symptom of AD that drives relapse in patients, is only insufficiently treated by existing medication. One promising new compound for the treatment of alcohol craving in AD is Cannabidiol (CBD), which showed beneficial effects on alcohol craving in preliminary clinical studies. Additionally, CBD seems to be a particularly promising candidate for enhancing the effects of established medication, specifically Naltrexone (NTX), an opioid-antagonist, which is approved for AD treatment, due to the synergistic effects of the combination of Cannabidiol plus Naltrexone on alcohol consumption that were shown by preclinical studies. The proposed three-armed, 1:1:1 randomized, double-blind, placebo-controlled parallel group, multicentric phase II trial seeks to test the putative synergistic effects of combined CBD (800mg) + oral NTX (50mg) against CBD (1200mg) + oral NTX (50mg) against Placebo + oral NTX (50mg) on alcohol craving (primary outcome) in male and female patients with AD that suffer from high alcohol craving. The trial seeks to test the effects of the innovative combination of CBD plus NTX against Placebo plus NTX on alcohol craving over a 14-day treatment period, which is embedded in a standardized addiction treatment program according to current treatment guidelines, in order to estimate the added value of treatment with CBD on alcohol craving. Quality of life and neurobiological and biochemical markers for craving will serve as secondary outcomes, because they show strong associations to treatment outcome and relapse risk. Collection and analysis of follow-up data (28 days, 42 days, 105 days, 196 days) will be performed to determine whether treatment effects relate to patient outcome.",[28,29],"Alcohol Addiction","Alcoholism","RECRUITING","2026-01-30",{"date":33,"type":34},"2026-02-03","ACTUAL",{"date":36,"type":34},"2025-07-22",{"date":38,"type":22},"2028-09-30",{"name":40,"class":41},"Central Institute of Mental Health, Mannheim","OTHER",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100564254","phase-1-brain-signal-training-to-enhance-affect-down-regulation-100564254","NCT06626789","Brain Signal Training to Enhance Affect Down-regulation","A Multi-center, Patient-blinded and Investigator-blinded, Randomized, Parallel-group, Superiority Study to Compare the Efficacy of Four Sessions of Amygdala fMRI-BOLD Neurofeedback With Yoked Sham-control Neurofeedback in the Treatment of Dysregulated Affect in Borderline Personality Disorder","BrainSTEADy","Stage 1: 82 patients, stage 2: 82 patients Inclusion Criteria\n\n1. 18-65 years\n2. Diagnosis of Borderline Personality Disorder\n3. Insufficient response to ≥2 therapies.\n4. Sufficient German language skills to give informed consent to the study, to understand questions posed by used instruments, and capable of completing the fMRI tasks\n5. Ability of subject to understand character and individual consequences of clinical investigation\n6. Written informed consent (must be available before enrollment in the clinical investigation)\n7. For women of childbearing potential (WOCBP) adequate contraception.\n\nExclusion Criteria\n\n1. Treatment with benzodiazepines within 7 days prior the initial screening\n2. Current alcohol or substance dependence\n3. Meeting the diagnostic criteria for a psychotic disorder or schizophrenia (life-time), as determined by clinical interview at initial screening\n4. Current or history of significant neurological condition (such as stroke, traumatic brain injury, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack)\n5. Significant visual impairment that might interfere with the performance of the behavioural tasks or fMRI tasks\n6. Change of treatment (psychopharmacologic, psychological) 2 weeks prior to or during the study participation\n7. Treatment with any neurofeedback three months prior to or during the study participation.\n8. Unable or unwilling to comply with study procedures, including study prohibitions and restrictions\n9. History of claustrophobia or inability to tolerate scanner environment\n10. Fulfilling any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants)\n11. Clinically relevant structural brain abnormality as determined by prior MRI scan\n12. Planned medical treatment within the study period that might interfere with the study procedures\n13. Participants deemed to be at significant risk of serious violence or suicide\n14. BMI of 16.5 or lower\n15. Participation in other clinical trials or observation period of competing trials, respectively\n16. Previous participation in this trial\n17. Pregnancy and lactation\n18. Held in an institution by legal or official order\n19. Legally incapacitated.","65 Years",{"count":53,"type":22},164,[55,25],"PHASE1","Individuals with Borderline Personality Disorder (BPD) experience intensive, instable negative emotions. Hyperactivity of the amygdala is assumed to drive exaggerated emotional responses in BPD. Neurofeedback is an endogenous neuromodulation method to address the imbalance of neural circuits. Downregulation of amygdala hyperactivation with neurofeedback may ameliorate dysregulated emotions in BPD. The BrainSTEADy trial is designed to determine whether amygdala-fMRI-BOLD neurofeedback has a specific effect on affect instability in BPD beyond nonspecific benefit.",[58],"Borderline Personality Disorder",[60,61,62,63,64,65],"Neurofeedback","fMRI","Neuroimaging","Amygdala","Affect instability","Emotion",{"date":33,"type":34},{"date":68,"type":34},"2025-04-23",{"date":70,"type":22},"2028-06",{"name":40,"class":41},6,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100551199","maintenance-electroconvulsive-therapy-in-clozapine-resistant-schizophrenia---the-mect-resist-trial-100551199","NCT06456983","Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial","MECT-RESIST","Inclusion Criteria:\n\n* Current schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), BPRS total score \\> 45 and history of clozapine resistant schizophrenia (CRS), which will include treatment-resistant schizophrenia with clozapine intolerance or absolute contraindications for clozapine;\n\nExclusion Criteria:\n\n1. Diagnosis of DSM-5 major neurocognitive disorder (\"dementia\"), current severe substance-use disorder, affective disorders with psychotic symptoms or any personality disorder;\n2. Inability to read\u002Fwrite German\n3. Pregnancy or breast-feeding;\n4. General medical condition contraindicating ECT.","75 Years",{"count":82,"type":22},140,[84],"NA","Schizophrenia is one of the most severe and costliest mental disorders in terms of human suffering and societal expenditure. About 15-30% of patients do not respond to all known antipsychotics, including clozapine, the current gold-standard in these cases. Hence, a recent Cochrane review stated that the quality of the existing studies is too poor to recommend any intervention in addition to clozapine and that new, randomized controlled trials independent from the pharmaceutical industry need to be performed to substantially improve patient care. Although electroconvulsive therapy (ECT) was initially used to treat schizophrenia, it is nowadays by far underused in the therapy of schizophrenia in many countries. ECT is well known to be highly effective in clozapine-treatment-resistant schizophrenia (CRS), and synergistic effects of clozapine and ECT have been demonstrated. However, relapse rates after successful courses of ECT are still very high, and evidence for maintenance ECT (mECT) in CRS is scarce at best. In a multi-center trial the investigators aim to examine the effectiveness of mECT in treatment-resistant patients with schizophrenia who improved after a course of routine ECT. If mECT will lead to a later timepoint of relapse and\u002For to a higher proportion of relapse-free patients compared to those undergoing treatment as usual, this trial would have an enormous impact on therapeutic strategies for \"treatment-resistant\" patients and would induce a profound change of current treatment guidelines, where ECT still ranks at the level of ultima ratio, despite accumulating evidence suggesting otherwise.",[87,88],"Schizophrenia","Treatment Resistant Schizophrenia",[90,91],"electroconvulsive therapy","ECT",{"date":33,"type":34},{"date":94,"type":34},"2025-02-14",{"date":96,"type":22},"2028-07",{"name":40,"class":41},14,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":42},"100589817","modification-of-inhibitory-control-and-craving-through-transcranial-direct-current-stimulation-tdcs-as-an-add-on-treatment-for-substance-use-disorder-100589817","NCT06959342","Modification of Inhibitory Control and Craving Through Transcranial Direct Current Stimulation (tDCS) as an Add-On Treatment for Substance Use Disorder","Inclusion Criteria:\n\n* main diagnosis: alcohol use disorder according to DSM-5\n* patients of any gender aged 18 to 65\n* normal vision or correctable visual impairment.\n* sufficient ability to communicate verbally and in writing\n* ability to give fully informed consent after reviewing thorough written information\n\nExclusion Criteria:\n\n* withdrawal of consent\n* severe internal, neurological, or psychiatric comorbidities (e.g., lifetime schizophrenia, bipolar disorder, or other severe mental disorders according to ICD-10 and DSM-5, such as severe depression or PTSD within the last 12 months).\n* Exclusion criteria for an EEG\u002FtDCS examination (e.g. metal implants in the head, epilepsy, etc.)\n* severe withdrawal symptoms (CIWA-R \\> 7)\n* alcohol intoxication (breath alcohol concentration \\> 0 ‰)\n* Pharmacotherapy with psychoactive substances within the last 14 days (exceptions: clomethiazole or benzodiazepines used in withdrawal treatment, provided they were discontinued at least 3 days prior; antidepressants or anxiolytics taken at stable doses).\n* drug or alcohol use within the last 7 days\n* for women: pregnancy\n* suicidal tendencies or danger to others",{"count":106,"type":22},162,[84],"The aim of this project is to investigate the potential of transcranial direct current stimulation (tDCS) to reduce cognitive deficits and substance craving in individuals with substance use disorders (SUD), with a focus on alcohol use disorder (AUD). Patients of any gender between the ages of 18 and 65 are examined who are in our inpatient and day clinic settings for a standard detoxification treatment program. As there are conflicting findings regarding the effective settings for tDCS as an adjunctive treatment in SUD (e.g., effects on inhibitory control seem to be sensitive to current direction), the aim is to examine and compare three different active tDCS conditions, a sham tDCS condition (placebo), inhibition training, and a control group of patients receiving only standard detoxification treatment. The aim is to identify the optimal electrode placement and current direction to positively influence both inhibitory control and craving, leading to improved treatment outcomes such as longer abstinence periods or reduced substance use after relapse.",[110,111],"Alcohol Use Disorder","Substance Use Disorders",[113,114,115,116,117,118,119,120],"Transcranial Direct Current Stimulation","tDCS","Inhibition Training","Electroencephalography","EEG","Inhibitory Control","Working Memory","Craving","2025-05-28",{"date":123,"type":34},"2025-06-04",{"date":125,"type":34},"2024-09-23",{"date":127,"type":22},"2027-09-30",{"name":40,"class":41},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":147,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":42},"100524217","neurobehavioral-profiles-of-adaptive-stress-responses-in-individuals-with-alcohol-use-disorder-100524217","NCT06105853","Neurobehavioral Profiles of Adaptive Stress Responses in Individuals With Alcohol Use Disorder","Towards Neurobehavioral Profiles and Models of Adaptive Stress Responses and Resilience in Individuals With Alcohol Use Disorder","A03","Inclusion criteria are:\n\n* age between 16 and 65 years\n* meeting at least 2 criteria of an alcohol use disorder according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5), yet without the need for a therapeutic intervention\n* fluency in German\n* able to understand the study procedures and give informed consent\n* willingness to use a study smartphone\n\nExclusion criteria are:\n\n* current use of drugs or medications that interact with the central nervous system or the glucocorticoid system\n* contraindications for magnetic resonance imaging\n* medical history of bipolar disorder, psychotic disorder, schizophrenia or schizophrenic spectrum disorder, or substance use disorder other than alcohol, nicotine, or cannabis\n* medical history of severe head injury or other severe central nervous system disorders or other severe somatic disorders (e.g. liver cirrhosis)\n* pregnancy",{"count":138,"type":22},100,[84],"The goal of this observational study is to investigate longitudinal stress response profiles and adaptive versus non-adaptive stress responses in alcohol use disorder. The main questions the projects aims to answer are:\n\nWhat are the neurobehavioral underpinnings of adaptive stress responses and resilience to repeated stress exposure with regards to:\n\n* alcohol craving?\n* alcohol use?\n* their modulation by prior stress exposure, social interactions, coping strategies and individual health behavior?\n\nParticipants will:\n\n* be exposed to an established experimental stress-induction protocol, the Trier Social Stress Test\n* be exposed to their favorite drink in a bar lab environment\n* be assessed using fMRI to determine their neural alcohol cue reactivity, response inhibition, and emotion processing\n* conduct an ambulatory phase to assess stressors, alcohol craving, substance use and details on social interactions, health behavior and coping strategies using ecological momentary assessment tools.",[110,142,143,120,144,145,146],"Stress Reaction","Social Stress","Relapse","Addiction, Alcohol","Risk Behavior",[148,149,150,151,152,153,154,155],"stress","resilience","craving","sensitization","habituation","cortisol","ecological momentary assessment","alcohol use disorder","2025-04-28",{"date":158,"type":34},"2025-04-29",{"date":160,"type":34},"2023-12-01",{"date":162,"type":22},"2027-06-30",{"name":40,"class":41},{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":177,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":4},"100242739","electroconvulsive-therapy-for-treatment-of-alzheimers-disease-100242739","NCT02438202","Electroconvulsive Therapy for Treatment of Alzheimer´s Disease","ECTAD","Inclusion Criteria:\n\n* confirmed Diagnostic and Statistical Manual of Mental Disorders (DSM IV) diagnosis of Alzheimer's disease (Mini Mental State Examination \\>5 and \\\u003C26)\n* routine treatment of AD due to German national guidelines (\"S3-Leitlinie\")\n* Ability to consent. If in doubt an independent (from the study) psychiatrist has to document ability to consent. If no ability to consent is stated, a legal guardian can consent instead. No ECT will be performed against the patient's will.\n\nExclusion Criteria:\n\n* contraindications for ECT\n* current major depressive episode due to DSM IV",{"count":172,"type":22},15,[84],"Electroconvulsive therapy (ECT) induces a cerebral seizure by electrical stimulation under general anesthesia and muscle relaxation, is regarded as a highly efficient (for specific and severe psychiatric disorders) and extremely safe modern treatment option.\n\nAlzheimer´s disease (AD) is a neurodegenerative disorder which is characterized by progressive cognitive deterioration accompanied by declining activities of daily living, by a variety of behavioral disturbances and by neuropsychiatric symptoms. The clinical progression of disease can be delayed by pharmaceutical therapies like acetylcholinesterase inhibition (e.g. rivastigmine) for 6 to 12 months at most.\n\nAlong with the well-known biomarkers of AD (Aß- and tau-proteins) a lower brain-derived neurotrophic factor (BDNF) level is since recently being considered as a negative predictor for the further disease course. In animal experimental studies it was possible to arrest the disease progression with the aid of neurotrophic substances. Many single studies, but also a number of meta-analyses show primary gray matter atrophy in hippocampal, parahippocampal and medial temporal brain regions.\n\nStrikingly, ECT yields exact opposite effects to those caused by AD: an ECT series leads to an increase of serum BDNF-levels in patients. Parallel to this observation evidence exists for gray matter volume gain after an ECT series, especially for the hippocampus.\n\nThere is sufficient clinical experience regarding the use of ECT in AD-patients, mainly on the basis of following indications: a) affective disorders and b) behavioral disturbances. A positive effect of ECT on the symptoms of agitation and aggression was assessed in AD patients alongside with a very good tolerability.\n\nTo investigate the potential salutary effects of ECT on AD the investigators designed a pilot study with the following concept: Patients with a confirmed AD diagnosis and preexisting stable antidementia medication over at least 6 months will receive a modified maintenance ECT over a total of 27 weeks.\n\nIn the proposed pilot study, the investigators hypothesize that cognitive functioning of AD patients will improve significantly and independently from affective symptoms, when initial and final examinations are compared. The affirmation of the hypothesis would provide not only further insight into the mechanism of action of ECT but also a very important reference point for the development of new treatment options for a so-far incurable disease.",[176],"Alzheimer's Disease","NOT_YET_RECRUITING","2025-04-02",{"date":180,"type":34},"2025-04-03",{"date":182,"type":22},"2026-12",{"date":184,"type":22},"2028-01",{"name":40,"class":41},{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":23,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},"100583859","phase-2-enhancing-social-skills-in-schizophrenia-spectrum-disorders---oxytocin-as-add-on-to-psychosocial-treatment-100583859","NCT06881810","Enhancing Social Skills in Schizophrenia Spectrum Disorders - Oxytocin as add-on to Psychosocial Treatment","Enhancing Social Skills in Schizophrenia Spectrum Disorders - Two-arm, Double-blind, Randomized Clinical Trial Investigating Oxytocin vs. Placebo as an add-on to an Individualized Psychosocial Treatment (OXY-APS)","OXY-APS","Inclusion Criteria:\n\n1. Age 18 to 64 years\n2. Written informed consent (must be available before enrolment in the clinical trial)\n3. ICD-11 diagnosis of schizophrenia or other primary psychotic disorders (6A20-6A25) confirmed by the MINI-DIPS-OA Interview\n4. At least one symptom of moderate severity or worse in the PANSS negative subscale (a score ≥ 4 for one or more symptoms from N1-N7 at baseline).\n5. In- or outpatient psychosocial treatment on a regular basis at least twice a week during the study\n6. Male participants and female participants who are not capable of bearing children or female patients of childbearing potential who use a highly effective birth control method that is medically approved by the health authority at screening.\n\n1\\. Age 18 to 64 years 2. Written informed consent (must be available before enrolment in the clinical trial) 3. ICD-11 diagnosis of schizophrenia or other primary psychotic disorders (6A20-6A25) confirmed by the MINI-DIPS-OA Interview 4. At least one symptom of moderate severity or worse in the PANSS negative subscale (a score ≥ 4 for one or more symptoms from N1-N7 at baseline). 5. In- or outpatient psychosocial treatment on a regular basis at least twice a week during the study 6. Male participants and female participants who are not capable of bearing children or female patients of childbearing potential who use a highly effective birth control method that is medically approved by the health authority at screening.\n\nExclusion Criteria:\n\n1. Patients who are not suitable for the study in the opinion of the investigator (including acutely suicidal patients)\n2. Coercive treatment at the time of study inclusion\n3. Diagnosis of primary substance dependency other than nicotine: exclusion alcohol dependency via AUDIT-screening (Bohn, Babor et al. 1995; Babor et al. 2001) and ICD- 11 criteria (MINI-DIPS-OA); exclusion of other drug dependencies other than alcohol and nicotine: drug screening of urine and ICD-11 criteria (MINI-interview: patient fulfilling early (\\> 3 months) or sustained (\\>12 months) remission criteria and\u002For with low severity of substance use disorder according to MINI (ICD-11) are eligible for the study).\n4. Documented intolerance to the study drug or any of its ingredients.\n5. Pregnancy (incl. positive urine or blood pregnancy test) \u002F breastfeeding (female patients) or lactating individuals\n6. Severe endocrinological disorder besides diabetes\n7. Endometriosis\n8. Concurrent participation","64 Years",{"count":196,"type":22},98,[25],"Research on schizophrenia spectrum disorders (SSD) patients with social impairment is essential for improving treatment, enhancing the lives of affected individuals, reducing stigma, and advancing our understanding of this complex psychiatric disorder. A clinical trial focusing on the improvement of social skills in SSD has the potential to transform clinical practice and support systems to better meet the needs of those living with SSD. Because of the role of oxytocin in regulating social behaviors and emotions, the investigator hypothesizes that it is beneficial in addressing the social cognition deficits observed in SSD when combined with psychosocial interventions.",[200],"Schizophrenia Spectrum Disorders (SSD)","2025-03-18",{"date":203,"type":34},"2025-03-21",{"date":205,"type":34},"2024-08-29",{"date":207,"type":22},"2028-03-31",{"name":40,"class":41},1,{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":217,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":209},"100495043","increasing-smoking-cessation-success-through-sleep-amplified-memory-consolidation-100495043","NCT05726045","Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation","Increasing the Smoking Cessation Success Rate by Enhancing Improvement of Self-control Through Sleep-amplified Memory Consolidation","Inclusion Criteria:\n\n* severe tobacco use disorder (TUD) according to DSM-5\n* sufficient ability to communicate with investigators and answer questions in both written and verbal format\n* ability to provide fully informed consent and to use self-rating scales\n* right-handedness\n* HIIT can be performed without the risk of side effect (medical sports check)\n\nExclusion Criteria:\n\n* severe internal, neurological, and\u002For psychiatric comorbidities; other Axis I mental disorders other than TUD according to ICD-10 and DSM 5 (except for mild depression, i.e. F32.0, adjustment disorder and specific phobias) in the last 12 months\n* history of brain injury\n* severe physical diseases\n* common exclusion criteria for MRI (e.g. metal, claustrophobia)\n* positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)\n* psychotropic medication within the last 14 days\n* pregnancy",{"count":82,"type":22},[84],"The goal of this subproject is to examine the hypothesized improvement of treatment with chess-based training and sleep enhancement, both together and on their own, in smokers.\n\nParticipants will undergo fMRI measurements, sleep monitoring. They will then be assigned to one of the four experimental groups, including high-intensity interval training with or without chess-based training.",[221],"Tobacco Use Disorder",[223,224,225,144,226,227],"Addiction","Nicotine","Smoking Cessation","Cognitive remediation","Exercise training","2025-01-29",{"date":230,"type":34},"2025-01-31",{"date":232,"type":34},"2024-04-01",{"date":234,"type":22},"2026-06-30",{"name":40,"class":41},{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":252,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":209},"100535090","using-neurofeedback-to-understand-the-relationship-between-stress-and-alcohol-consumption-100535090","NCT06247306","Using Neurofeedback to Understand the Relationship Between Stress and Alcohol Consumption","Probing the Influence of Neural Stress Responses on Problematic Alcohol Use With Real-time fMRI Neurofeedback (C04)","NeuStress","Inclusion Criteria:\n\n* Age 18-65 years\n* Presence of 2 to a maximum of 5 criteria for alcohol use disorder according to DSM-5\n* no clinical necessity for detoxification treatment\n* participants may have a moderate cannabis use disorder and tobacco use disorder\n* Capacity for consent and ability to use self-assessment scales\n* Sufficient knowledge of German\n* Willingness to use a mobile phone with Android operating system\n\nExclusion Criteria:\n\n* Lifetime diagnosis of bipolar or psychotic disorder or a substance use disorder according to Diagnostical and Statistical Manual of Mental Disorders - 5 (DSM-5) that is not alcohol, cannabis, or tobacco use disorder\n* Current substance use other than cannabis and tobacco\n* Current diagnosis of one of the following conditions according to DSM-5: (hypo)manic episode, major depression, generalized anxiety disorder, post-traumatic stress disorder, borderline personality disorder, or obsessive-compulsive disorder\n* History of severe head trauma or other severe central neurological disorders (dementia, Parkinson\\'s disease, multiple sclerosis)\n* Pregnancy or lactation\n* Use of medications known to interact with the central nervous system within the last 10 days; testing at least four half-lives after the last dose\n* Exercising the prerogative of the \\"Right not to know\\" in the context of incidental findings during an examination or investigation",{"count":245,"type":22},102,[84],"In this research project, the aim is to discover the role specific brain networks play in the relationship between stress reactions and the desire for alcohol and alcohol consumption. To investigate this question, various brain imaging methods as well as cognitive tasks are combined. Various questionnaires are sampled and brain scans are conducted.\n\nIndividuals interested in participating in the study have to fulfill certain criteria...\n\n* no serious medical or mental health diagnosis\n* problematic alcohol drinking habits\n* interested in improving drinking habits\n\n  ...and undergo various non-invasive procedures\n* filling out several questionnaires concerning personality and habits\n* undergoing a mental performance task while being in a brain scanner (MRI)\n* attempting to regulate their own brain activity while lying in the MRI scanner\n* filling out an electronic diary for 6 weeks - concerning daily mood, stress, and alcohol habits\n\nParticipants will be randomly allocated to either one of 2 experimental groups. Both groups undergo the same tasks, receive the same instructions and only differ regarding some aspects of the brain self-regulation task .",[249,120,250,251],"Alcohol Abuse","Psychosocial Stressor","Neural Stress Response",[253,254,255,256,153,257],"functional Magnetic Resonance Imaging (fMRI)","psychosocial stress","real-time fMRI neurofeedback (rtfMRI neurofeedback)","problematic alcohol use","Ecological momentary assessment (EMA)","2025-01-22",{"date":260,"type":34},"2025-01-23",{"date":262,"type":34},"2024-03-01",{"date":264,"type":22},"2027-07-01",{"name":40,"class":41},""]