Bipolar 1 Disorder

6

Review clinical trials related to Bipolar 1 Disorder. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Socio-cognitive and Biological Responses to Maltreatment

The study will investigate how a history of emotional childhood maltreatment (CM) is associated with different aspects of psychological (social behaviour, empathy) and biological (brain function and structure, inflammation) health. In fact, CM is a risk factor for many mental disorders, such as schizophrenia and autism. However, it is unclear how a history of emotional CM affects psychological and biological outcomes in bipolar disorder (BD). Therefore, this study focuses on understanding how a possible history of CM affects BD compared to control participants (CP) with no known psychiatric illness. The aim of the project is to investigate how a history of emotional CM is associated with social cognition. The investigators will recruit 80 CP and 80 people diagnosed with BD, some of whom will have a history of CM. The investigators will assess psychological well-being (social behaviour, empathy) at two points in time at the Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology at the Medical University of Innsbruck (MUI). Additionally, as they want to understand how emotional CM affects brain function and structure, the investigators will perform magnetic resonance imaging (MRI) of the brain at the Neuroimaging Core Facility (Medical University of Innsbruck). The investigators also want to understand how biological markers in the blood (such as telomere length, inflammation) might be affected, assessed in collaboration with the Department of Psychology (Leopold-Franzens University of Innsbruck). Finally, the investigators will look at a combination of the psychological and biological tests to see if there is a link between emotional CM and health outcomes.

Participants needed: 160
Trial details
Age: 18-65Biological sex: AllType: ObservationalSponsor: Medical University InnsbruckUpdated: Jun 29, 2026Locations: 1
Eligibility criteria

diagnosis of a moderate to severe depressive episode without psychotic features... [+3]

a history of one or more diagnoses of the following DSM-5 categories: past or cu... [+24]

Status: Not yet recruiting

Risperidone vs Cariprazine in Acute Mania

Randomized, double-blind, parallel-group study comparing efficacy and safety of Risperidone versus Cariprazine in adults with acute manic episodes. Participants will receive oral study drug for 6 weeks. Primary outcome is change in YMRS total score from baseline to week 6.

Participants needed: 50
Trial details
Phase: Phase 4Age: 18-60Biological sex: AllType: InterventionalSponsor: Pakistan Institute of Medical SciencesUpdated: Jun 24, 2026
Eligibility criteria

Not listed

Status: Recruiting

Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder

This is a clinical research study for an investigational drug called RAP-219 in participants with bipolar I disorder. This study is being conducted to determine if RAP-219 is safe and effective in participants experiencing mania associated with bipolar I disorder.

Participants needed: 250
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Rapport Therapeutics Inc.Updated: Jun 22, 2026Locations: 22
Eligibility criteria

Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (... [+1]

History of any of the following diagnoses: a. schizophrenia; schizoaffective dis... [+1]

Status: Recruiting

CLOZAPINE Response in Biotype-1

The CLOZAPINE study is designed as a multisite study across 5 sites and is a clinical trial, involving human participants who are prospectively assigned to an intervention. The study will utilize a stringent randomized, double-blinded, parallel group clinical trial design. B2 group will serve as psychosis control with risperidone as medication control. The study is designed to evaluate effect of clozapine on the B1 participants, and the effect that will be evaluated is a biomedical outcome. The study sample will be comprised of individuals with psychosis, including 1) schizophrenia, 2) schizoaffective disorder and 3) psychotic bipolar I disorder. The investigators plan to initially screen and recruit n=524 (from both the existing B-SNIP library and newly-identified psychosis cases, \~50% each) in order to enroll n=320 (B1 and B2) into the RCT.

Participants needed: 524
Trial details
Phase: Phase 4Age: 18-60Biological sex: AllType: InterventionalSponsor: University of Texas Southwestern Medical CenterUpdated: May 11, 2026Locations: 5
Eligibility criteria

18-60y/o; males and females; all races and ethnicities; able to provide written...

premorbid intellectual ability estimate below 70 (WRAT-4, Word Reading subtest,...

Status: Recruiting

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

The Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services (BICEPS) study aims to understand the early stages of psychotic disorders like Schizophrenia, Schizoaffective Disorder, and Bipolar I Disorder. It involves gathering mental health information, brain scans (MRI), eye movement patterns (Eye-Tracking), and brain electrical waves (EEG) data from individuals who have experienced these disorders in recent years. Participants will be involved for about a year, with four visits over this period. Screening procedures, lasting approximately 3 hours, include tests for drug use, a pregnancy test for eligible women, clinical interviews about feelings and experiences, psychiatric and family history interviews, and a medical history review. Research procedures for eligible participants include DNA collection, a neuropsychological test battery, EEG, eye-tracking, and MRI. These procedures will help researchers understand brain function, genetics, and cognitive abilities related to psychotic disorders. Follow-up visits at 1-month, 6-month, and 12-month intervals involve modified clinical interviews and repeating neuropsychological tests to track changes over time. Participants may opt to provide DNA samples for genetic analysis, undergo various cognitive tests, EEG to record brain waves, eye-tracking to monitor eye movements, and MRI scans to visualize brain structure. Follow-up visits at regular intervals will help researchers track changes in symptoms and cognitive function. This study provides comprehensive insight into the onset and progression of psychotic disorders and offers valuable information for patients, families, and healthcare providers involved in managing these conditions. Our goal is to better understand whether a combination of biological markers and different types of people (BT1, BT2, BT3) can help us predict how well individuals with early psychosis respond to specialized care. We expect that those in BT3 will have the best outcomes, BT2 will have intermediate outcomes, and BT1 will have the poorest outcomes. Even though BT1 and BT2 might start with similar cognitive issues, their biology might lead to different responses to treatment. This research can help us understand which treatments work best for different people with early psychosis.

Participants needed: 320
Trial details
Age: 18-40Biological sex: AllType: ObservationalSponsor: Beth Israel Deaconess Medical CenterUpdated: Mar 10, 2026Locations: 6
Eligibility criteria

Males and females, all races and ethnicities [+6]

Estimated premorbid intellectual ability <70 (WRAT-4, Word Reading subtest, age-... [+6]

Status: Recruiting

Feasibility and Preliminary Results of the Efficacy of Blue-Blocking Glasses on Manic Symptoms in Bipolar Disorder

The goal of this clinical trial is to assess the feasibility of conducting a clinical trial of the use of blue-blocking glasses among patients with a type1 bipolar disorder, experiencing a manic episode. The feasibility criteria include: recruitment rates, participation rates, adherence to the research protocol, the material feasibility of the study. Feasibility criteria will be assessed at the end of the study period. The investigators also want to assess patients' acceptability regarding the use of blue-blocking glasses during a manic episode, using self-reported satisfaction criteria. Those criteria will be monitored at the end of participation period for each patient (7 days after inclusion). In addition, the study will evaluate the impact of the use of blue-blocking glasses on the severity of manic symptoms, sleeping pattern (quality of sleep, sleep latency, night wake, etc.), global functioning, and on suicidal ideations. Those indicators will be assessed at day 0 (inclusion), day 3 and day 7, using validated questionnaires and actimetry data. The study is presented to all patients over 18 years old, with type 1 bipolar disorder, presenting a manic episode, hospitalised in an adult psychiatric ward of Bichat Hospital (GHU Paris). Patients' participation duration is of 7 days after inclusion.

Participants needed: 25
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Centre Hospitalier St AnneUpdated: Sep 26, 2025Locations: 1
Eligibility criteria

Patient over 18 years old [+1]

Patient who did not agree to participate to the study [+4]