[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"treatment-resistant-bipolar-depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:treatment-resistant-bipolar-depression":58},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100642096","phase-2-adjunctive-oral-ket-ad-capsules-in-treatment-resistant-bipolar-depression-100642096",false,"NCT07644767","Adjunctive Oral KET-AD Capsules in Treatment Resistant Bipolar Depression","Abuse-deterrent Immediate Release Oral Ketamine Capsules for Treatment Resistant Bipolar Depression: A Phase 2A, Randomised, Double-blind, Placebo-controlled Study","Inclusion Criteria:\n\n1. Male or female aged 18 to 65 years (inclusive) at the time of informed consent, with first major depressive episode (MDE) before the age of 50 years.\n2. Body mass index (BMI) between 18 and 40 kg\u002Fm2, inclusive.\n3. Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for BD (any type) currently experiencing a depressive episode, without psychotic features, based upon clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (MINI).\n4. Current MDE must be moderate to severe, as determined by the Hamilton Depression Rating Scale (HDRS-17) score \\> 20 with inadequate response (lack of clinically meaningful improvement of clinical symptoms) to 2 or more adequate evidence based treatment trials for bipolar depression, as per the 2018 Canadian Network for Mood and Anxiety Treatments (CANMAT) Bipolar Disorder Guidelines (25) as assessed using the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and documented by records (eg, medical\u002Fpharmacy\u002Fprescription records or a letter from treating physician etc.), for the current episode of depression.\n5. Participant is taking a stable dose of a guideline concordant treatment for the bipolar depression on the MGH-ATRQ for at least 6 weeks at or above the minimum therapeutic dose.\n6. Any psychotherapeutic treatment has been stable for at least 6 weeks prior to Screening, with no anticipated changes in frequency or therapist anticipated until after the EOS visit.\n7. Willing to abstain from recreational\u002Fillicit drugs from Screening until the end of the study.\n8. Willing to allow their own GP and\u002For other mental health professional, to be informed of study participation and agree to the participant withdrawing from their current medication as required.\n9. Participant has stable, euthyroid thyroid function at Screening, as confirmed by laboratory results. Participants with a history of thyroid disease may be included if they are clinically euthyroid and have been on a stable thyroid treatment regimen for at least 2 months prior to the Screening visit.\n10. Woman of childbearing potential (WOCBP) or fertile man agrees to use an acceptable method of contraception from at least 1 month prior to the Screening visit (WOCBP) or the start of Screening (fertile man) until 90 days after the last dose of IP. WOCBP must agree to not donate eggs and males must agree to not donate sperm from the first dose of IP until at least 90 days after the last dose of IP.\n11. Not pregnant or breastfeeding, or willing to cease breastfeeding.\n12. Any form of exercise, including but not limited to, sporting activities, gym, yoga or Pilates attendance, has been stable for at least 6 weeks prior to Screening, with the participant agreeable to not making changes to their type or frequency of exercise\u002Fs until after the EOS visit.\n13. Able and willing to attend the necessary visits to the study site.\n14. Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.\n\nExclusion Criteria:\n\n1. In the Investigator's opinion, participant has chronic, refractory treatment resistant depression characterised by a lifetime history of \\> 4 adequate therapeutic trials of guideline concordant medications for bipolar depression (with or without adjuvants and\u002For electroconvulsive therapy \\[ECT\\]) without response, as confirmed by the MGH-ATRQ.\n2. Current MDE for longer than 12 months prior to the Screening visit.\n3. Current symptoms of mania, hypomania, or mixed features, as determined by the YMRS score \\> 12.\n4. Has a history or current diagnosis of rapid cycling BD.\n5. History of mania or hypomania in the past 6 months as determined by psychiatric history.\n6. Has a current substance use disorder or history of any substance use disorder per DSM-5 criteria within 6 months prior to Screening, except for tobacco use disorder.\n7. Has a history or current diagnosis of schizophrenia, schizoaffective disorders, or any psychotic disorder. Has posttraumatic stress disorder, obsessive compulsive disorder, autism spectrum disorder, borderline personality disorder, antisocial personality disorder, narcissistic personality disorder or histrionic personality disorder, or any other mental disorder with psychotic features.\n8. Has past suicidal behaviour and\u002For suicidal thoughts with an intention defined by:\n\n   1. suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, during the Screening period, or at Baseline; or\n   2. suicidal behaviours within the past year; or\n   3. clinical assessment of significant suicidal risk during clinical interview; or\n   4. non-suicidal self-injury within the past year.\n9. Has dementia, delirium, amnesia, or any other significant cognitive disorder.\n10. Has any known aneurysmal disease, recent myocardial infarction (MI) (within past 12 months), or medical condition for which an increase in blood pressure or intracranial pressure poses a serious risk. Has clinically significant cardiovascular disorders such as uncontrolled atrial fibrillation, heart failure, or ischaemic heart disease.\n11. Recent hospitalisation (within 6 months of Screening) for procedures, such as percutaneous coronary intervention or coronary artery bypass surgery.\n12. Has prolonged QTcF interval at Screening (QTcF \\> 450 msec for men and \\> 470 msec for women).\n13. Has uncontrolled hypertension (≥ 140 mm Hg systolic or ≥ 90 mm Hg diastolic).\n14. Participants who have taken phencyclidine (PCP)\u002Fketamine within 12 months prior to the Screening visit.\n15. Has had vagal nerve stimulation, deep brain stimulation, ECT, or transcranial magnetic stimulation during the current MDE episode.\n16. Has current or history of seizures. Note: uncomplicated childhood febrile seizures with no sequelae are not exclusionary.\n17. Has medically unstable condition such as clinically significant neurological, hepatic, renal, metabolic, haematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.\n18. Has unstable diabetes mellitus (insulin dependent diabetes mellitus \\[IDDM\\] and non IDDM) of HbA1C \\> 7.0 or above or fasting blood sugars \\>125 mg\u002FdL.\n19. Participant has a history of, or symptoms and signs suggestive of, liver cirrhosis (eg, oesophageal varices, ascites, and increased prothrombin time) OR alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values \\> 2× the upper limit of normal (ULN) or total bilirubin \\>1.5× the ULN during Screening.\n\n    For elevations in bilirubin if, in the opinion of the Investigator and agreed upon by the Sponsor's medical officer, the elevation in bilirubin is consistent with Gilbert's disease, the participant may be enrolled in the study.\n20. Participants with known history of, or a positive test for, HIV.\n21. Participants with an active hepatitis B and\u002For hepatitis C infection.\n22. Poor pill swallowing ability.\n23. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents.\n24. Positive toxicology screening panel (urine test including qualitative identification of barbiturates, tetrahydrocannabinol \\[THC\\], amphetamines, benzodiazepines, opiates, methadone, methamphetamine, ecstasy \\[MDMA\\], phencyclidine, and cocaine), or alcohol breath test.\n25. Clinical laboratory values outside the normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or designee.\n26. Unwilling to abstain from alcohol from 24 hours before to 24 hours after each IP administration.\n27. Use of rifampicin, St John's wort, diazepam or secobarbital, clarithromycin, or moderate to strong CYP3A4 inhibitors within 30 days or 5 half-lives of the medication (whichever is longer) prior to first IP administration.\n28. Use of any investigational medical device or investigational drug within 30 days or 5 half lives of the investigational drug (whichever is longer) prior to the first administration of the IP.\n29. Anything that the Investigator considers would jeopardise the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.","ALL","18 Years","65 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is testing a new oral ketamine treatment called KET-AD in adults with treatment-resistant bipolar depression (TRBD). The study will look at how safe and tolerable the treatment is, and whether it may help improve symptoms of depression when used together with a participant's usual treatment.\n\nAbout 160 people will take part in the study. Participants will be randomly assigned (like flipping a coin) to receive either KET-AD or a placebo (a treatment with no active medicine). Neither the participant nor the study team will know which treatment the participant is receiving during the study.\n\nThe study treatment will be taken by mouth 3 times a week for up to 7 weeks. Participants will continue taking their usual standard treatment throughout the study.\n\nThe study has several parts:\n\nScreening Period (up to 28 days)\n\nBefore joining the study, participants will complete tests and assessments to confirm whether they are eligible to take part.\n\nTitration Phase (Weeks 1-3)\n\nThe first 3 weeks are used to find the highest dose of study treatment that each participant can comfortably tolerate.\n\nAll doses during this phase are given at the study clinic. Participants will start on a lower dose. Depending on how well the treatment is tolerated, the dose may be increased, kept the same, or reduced. The study doctor will carefully monitor participants for side effects after each dose.\n\nParticipants who cannot tolerate the treatment, or who cannot reach the required dose level by the end of Week 3, will stop study treatment and complete an early finish visit.\n\nMaintenance Phase (Weeks 4-7)\n\nParticipants who tolerate the treatment during the Titration Phase may continue into the 4-week Maintenance Phase.\n\nParticipants will stay on the same dose throughout this phase. Some doses will still be given at the study clinic. Other doses may be taken at home if approved by the study doctor. Home doses will be supervised remotely by a mental health professional using a secure telehealth app.\n\nParticipants will use an electronic app during the study. The app will be used to complete questionnaires and other study assessments both at the clinic and at home. Participants may use their own device or be provided with one by the study team. Training will be provided before participants begin using the app independently.\n\nSafety Monitoring\n\nParticipant safety will be closely monitored throughout the study by the study doctors and by an independent safety committee called a Data Safety Monitoring Board (DSMB).\n\nFollow-up Visits\n\nAfter treatment ends, participants will attend:\n\na follow-up clinic visit on Day 50, and an end-of-study visit on Day 64, which may be completed remotely.\n\nParticipants can leave the study at any time if they choose.",[27],"Treatment Resistant Bipolar Depression",[27,29],"Ketamine","NOT_YET_RECRUITING","2026-06-08",{"date":33,"type":34},"2026-06-12","ACTUAL",{"date":36,"type":21},"2026-10-30",{"date":38,"type":21},"2028-06",{"name":40,"class":41},"Neurocentrx Pharma Pty Ltd","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":63,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100636708","phase-2-ketamine-with-dialectical-behavioural-therapy-dbt-for-suicidality-in-individuals-with-treatment-resistant-depression-and-borderline-personality-disorder-ket-dbt-100636708","NCT07569198","Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)","Combining Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder: A Phase II Randomized, Midazolam-Controlled Clinical Trial (KET-DBT)","KET-DBT","Inclusion Criteria:\n\n1. Adults between the age of 18 to 70, inclusive;\n2. Meets criteria for BPD, as determined by clinical assessment by a psychiatrist or psychologist and confirmed by the International Personality Disorder Examination (IPDE);\n3. Meets DSM-5 criteria for MDD or BD (I or II), currently experiencing a MDE without psychotic features, as diagnosed by a study psychiatrist or psychologist. Diagnosis will be confirmed using the Mini- International Neuropsychiatric Interview (MINI);\n4. Current MDE must be moderate to severe, as determined by the MADRS score \\>20 with an inadequate response to two or more guideline-concordant treatment trials as defined by the Antidepressant Treatment History Form-Short Form (ATHF- SF);\n5. No changes in pharmacotherapy for MDD\u002FBD in the last month or changes in psychotherapy in the past month;\n6. Baseline SI as shown by two consecutive MSSI scores \\> 10 two weeks apart.\n\nExclusion Criteria:\n\n1. Past or current history of a psychotic disorder as determined by clinical assessment and MINI;\n2. Current or recent (within the past 3 months) manic or hypomanic episode as determined by clinical assessment via YMRS (score \\> 12) and the MINI;\n3. Meeting criteria for Moderate to Severe Alcohol or substance use disorders currently or within the past 3 months;\n4. Lifetime history of ketamine use disorder or illicit ketamine use.\n5. Acute suicide risk requiring involuntary inpatient treatment under the Mental Health Act (MHA).\n6. Presence of a relative or absolute contraindication to ketamine or midazolam, including a drug allergy, lifetime history of stroke, uncontrolled hypertension (Systolic BP \\> 160 or Diastolic BP \\> 100), low or labile blood pressure (Systolic BP \\\u003C 100 or Diastolic BP \\\u003C 60), recent (within the past 6 months) myocardial infarction, severe coronary artery disease (ascertained through participant's medical history), or moderate to severe renal (GFR scores ≤ 44) or hepatic impairment (A Child-Pugh score of ≥ 7);\n7. Currently pregnant or breastfeeding or planning on getting pregnant within the first two months of the trial or planning on getting someone else pregnant within the first two months of trial. Participants who are sexually active must agree to use a highly effective contraceptive method (please see exhaustive list in Section 3.6.1);\n8. Current use of prohibited concomitant medications, including other forms of ketamine or esketamine, high dose daily benzodiazepines (greater than 4 mg lorazepam equivalent daily) or monoamine oxidase inhibitors;\n9. Currently engaged (or completed within the past year) in DBT treatment. NOTE: Individuals who have received only DBT skills training in the past year will be considered eligible to participate;\n10. Those engaged in other forms of psychotherapy must be willing to discontinue for the duration of the 6-month DBT intervention (standard for DBT). There should be no changes in psychotherapy 30 days prior to baseline (i.e., Screening Visit 2).","70 Years",{"count":52,"type":21},120,[24],"The goal of this clinical trial is to learn if intravenous (IV) ketamine with Dialectical Behavioural Therapy (DBT) reduces suicidal ideation in individuals with suicidality who have been diagnosed with Borderline Personality Disorder and either Major Depressive Disorder or Bipolar Disorder. The main question it aims to answer is:\n\nDoes IV ketamine and DBT produce more rapid and robust improvements in suicidal ideation (SI) severity between baseline and Day 35 compared to IV midazolam and DBT, as measured by changes in the Modified Scale for Suicidal Ideation (MSSI) scores ?\n\nResearchers will compare six IV ketamine infusions and DBT to an active placebo (a look-alike substance that mimics some of ketamine's effects and not others) and DBT to see if IV ketamine with DBT is more effective at reducing SI severity.\n\nParticipants will:\n\n* Complete six infusions of either IV ketamine or IV midazolam\n* Take part in 6 months of DBT (includes both weekly one-on-one sessions, and group sessions, starting week 5 of the trial)\n* Visit the hospital for scheduled in-person visits\n* Join a call or videocall for scheduled remote visits\n* Complete a variety of different mood, cognitive and behavioral assessments",[56,57,58,59,60,61,62],"Borderline Personality Disorder (BPD)","Treatment-Resistant Major Depressive Disorder","Treatment-resistant Bipolar Depression","Major Depressive Disorder (MDD)","Bipolar Disorder (BD)","Bipolar Disorder I or II","Suicidal Ideation",[64,65,66,67,60,59,68],"Dialectical Behavioural Therapy (DBT)","ketamine","Borderline Personality Disorder","Treatment-Resistant Depression","Suicidality","2026-04-28",{"date":71,"type":34},"2026-05-06",{"date":73,"type":21},"2026-06-01",{"date":75,"type":21},"2029-08",{"name":77,"class":78},"Joshua Rosenblat","OTHER",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100325863","phase-1-adjunctive-allogeneic-mesenchymal-stem-cells-for-treatment-resistant-bipolar-depression-100325863","NCT03522545","Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression","Inclusion criteria:\n\n1. Diagnosis of DSM-IV-TR of Bipolar I or Bipolar II disorder as verified by the semi-structured diagnostic interviews SCID. The diagnosis may be supported by information from significant others, and from hospital records.\n2. Age: 18-65 years\n3. Severity: meet DSM-IV-TR criteria of depressive episode and MADRS of 25 or above\n4. Treatment resistance: None response to two trials (during lifetime) with mood stabilizers with proven efficacy in bipolar depression (lithium, lamotrigine, quetiapine, olanzapine) and\u002For antidepressants.\n\n   a A trial is defined as at least 6 weeks in adequate or tolerated dose as reported by the patient, or patients that have been unable to comply with 6 weeks trials of mood stabilizer or an antidepressant.\n\n   b None response: Less than 50% reduction in MADRS values or still meet DSM-IV-TR criteria of depressive episode\n5. CRP concentration greater than 5 mg\u002FL\n6. Female subjects whom are not pregnant, not breastfeeding, and not planning on becoming pregnant during the study. Female patients of childbearing potential must be using a reliable method of contraception.\n7. Patient competent to give informed consent according to the judgment of the clinician\n8. Written informed consent\n9. Patient sufficiently fluent in English language to ensure valid responses to psychometric testing (needed for validated neurocognitive outcomes testing)\n\nExclusion criteria:\n\n1. MSCs transplant within the last six months\n2. Inability to comply with study protocol\n3. Patient at high suicidal risk according to clinicians' judgement\n4. History of previous brain injury; neurologic impairment and\u002For deficit; seizure disorder requiring anti-convulsant therapy; renal disease or altered renal function as defined by serum creatinine 2x ULN at admission; hepatic disease or altered liver function as defined by SGPT \\> 2 x ULN (non-contusion related), and\u002For T. Bilirubin 1.5 x ULN at admission; immunosuppression as defined by WBC\\\u003C3,000 cells\u002Fml at admission; HIV, splenectomy or cancer\n5. Unstable serious medical conditions, including clinically relevant laboratory abnormalities. Conditions that affect neuropsychological assessment such as Parkinson's Disease, Multiple sclerosis, stroke, alcohol and substance abuse or dependence (according to SCID or DSM-IV-TR). Other serious medical illness that is not adequately controlled and, in the investigator's opinion, would not permit the subject to be managed according to the protocol.\n6. Hemodynamic instability at the time of MSCs infusion.\n7. Positive pregnancy test (at screening or baseline visits).",{"count":86,"type":21},30,[88],"PHASE1","The overall objective of the investigators is to assess the therapeutic efficacy and tolerability of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow for treatment of treatment-resistant bipolar depression patient (TRBD).",[58],[92,93,94],"treatment-resistant bipolar depression","bipolar disorder","manic depression","RECRUITING","2025-06-17",{"date":98,"type":34},"2025-06-22",{"date":100,"type":34},"2022-04-20",{"date":102,"type":21},"2026-12-01",{"name":104,"class":78},"The University of Texas Health Science Center, Houston",1]