Clinical trials: Bipolar I Disorder, open to volunteers
Bipolar I Disorder, Mania
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or…
- Trial name
- NCT07288320
- Testing
- NBI-1117568
- Where
- 11 sites in United States
- Volunteers
- 150 people
- Sponsor
- Neurocrine Biosciences
Bipolar Disorder Type I With Mania
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the…
- Trial name
- NCT06929273
- Testing
- KarXT, Lithium, Valproate
- Where
- 184 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Bristol-Myers Squibb
Bipolar I Disorder
Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.
Phase II study for patients with Bipolar 1 Disorder experiencing major depressive episode. Patient eligible for enrollment will be randomized (like flipping a coin) to either active drug (LB-102 or placebo).
- Trial name
- Illuminate1 (NCT07494305)
- Testing
- LB-102
- Where
- 26 sites in United States
- Volunteers
- 320 people
- Sponsor
- LB Pharmaceuticals Inc.
Bipolar Depression
Brexpiprazole Treatment for Bipolar I Depression
Bipolar disorder (BD) is a frequent and lifelong recurrent mood disorder with treatment-resistant depressive episodes. Importantly, depressive symptoms and cognitive decline are major determinants of functionality and quality of…
- Trial name
- NCT04569448
- Testing
- Brexpiprazole
- Where
- 3 sites in Canada
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Douglas Mental Health University Institute
Bipolar Affective Disorder
Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.
Initially, observational studies suggested a possible effect of Lacosamide on depressive and anxious symptoms in individuals with epilepsy, and later, an open-label study demonstrated the efficacy of lacosamide in improving…
- Trial name
- NCT07412132
- Testing
- Lacosamide
- Where
- Brazil
- Volunteers
- 40 people
- Sponsor
- University of Sao Paulo
Bipolar I Disorder, Bipolar II Disorder
Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder
The goal of this clinical trial is to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss, and to study the effect of individualized guided medication in…
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Schizo Affective Disorder, Obesity
- Trial name
- OBOE-Mayo (NCT07213466)
- Testing
- Group Therapy Program, semaglutide, Phentermine-Topiramate
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic
Schizophrenia, Schizo-Affective Disorder
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
- Conditions
- Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I
- Trial name
- NCT05025605
- Testing
- BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
- Where
- 5 sites in United States
- Volunteers
- 140 people
- Sponsor
- BioXcel Therapeutics Inc
Borderline Personality Disorder (BPD), Treatment-Resistant Major Depressive Disorder
Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)
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…
- Conditions
- Borderline Personality Disorder (BPD), Treatment-Resistant Major Depressive Disorder, Treatment-resistant Bipolar Depression, Major Depressive Disorder (MDD)
- Trial name
- KET-DBT (NCT07569198)
- Testing
- Ketamine Hydrochloride, Midazolam Hydrochloride, Dialectical Behavioral Therapy (DBT)
- Where
- Canada
- Volunteers
- 120 people
- Sponsor
- Joshua Rosenblat
Treatment-Resistant Depression, Bipolar Depression
Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for the Treatment of Refractory Bipolar Depression
The goal of this clinical trial is to evaluate the safety and initial effectiveness of MR-guided focused ultrasound (MRgFUS) bilateral capsulotomy in patients with treatment-resistant bipolar depression (TRBD).
- Trial name
- NCT07108257
- Testing
- ExAblate Neuro 4000
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Sunnybrook Health Sciences Centre
Cardio Vascular Disease, Metabolic Syndrome (MetS)
Norwegian Mental Illness Heart Health Study
Norwegian patients with severe mental illnesses (SMI), such as schizophrenia spectrum or bipolar disorder, lose on average 10 years of life compared to mentally healthy individuals. Much of this gap is due to heart disease.
- Conditions
- Cardio Vascular Disease, Metabolic Syndrome (MetS), Severe Mental Disorder, Schizophrenia and Schizophrenia Spectrum Psychosis
- Trial name
- NORMI-Heart (NCT07085923)
- Testing
- Lifestyle Intervention
- Where
- Norway
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Madeleine Elisabeth Angelsen
Schizoaffective Disorder, Depressive Type, Bipolar Disorder I
Biocollection on Peripheral Inflammation
Most psychiatric research is based on the nosographic classifications used in current practice. At present, there is no diagnostic or prognostic biomarker for psychiatric pathologies commonly used in clinical practice.
- Conditions
- Schizoaffective Disorder, Depressive Type, Bipolar Disorder I, Bipolar Disorder II
- Trial name
- IBIS-PSY (NCT05934474)
- Testing
- Peripheral venipuncture blood sampling, as part of standard care procedures, Interview with a psychiatrist
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Nantes University Hospital
Bipolar 1 Disorder
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.
- Trial name
- B2Bi (NCT07194278)
- Testing
- Blue-blocking glasses
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Centre Hospitalier St Anne
Major Depressive Disorder (MDD), Schizophenia Disorder
Prospective Observational Study of the Relationship Between Sociodemographic Factors, Blood-based Biomarkers and Psychiatric Symptoms in Neurodegenerative Diseases and Mental Disorders
This is a prospective observational study to identify sociodemographic factors that predict mental health outcomes in the European population and provide evidence linking common, modifiable sociodemographic risk factors for…
- Conditions
- Major Depressive Disorder (MDD), Schizophenia Disorder, Bipolar 1 Disorder, Alzheimer Disease
- Trial name
- Synapsing-SD (NCT07239843)
- Where
- Spain
- Volunteers
- 1,310 people, healthy volunteers welcome
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Depressive Disorder, Major, Bipolar Disorder
Psychiatric Genotype/Phenotype Project Repository
The purpose of this project is to obtain DNA, brain imaging data, other biological samples (e.g., urine, serum), and a comprehensive clinical assessment on patients with schizophrenia and other psychotic disorders, bipolar…
- Conditions
- Depressive Disorder, Major, Bipolar Disorder, Psychotic Disorders
- Trial name
- PGPP (NCT00762866)
- Where
- United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University
Schizophrenia, Bipolar I Disorder
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.
- Trial name
- NCT05648591
- Testing
- Iloperidone
- Where
- 11 sites in United States
- Volunteers
- 100 people
- Sponsor
- Vanda Pharmaceuticals
Bipolar I Disorder, Bipolar Depression
Safety and Feasibility of DBS for Bipolar Depression
This study addresses a critical unmet need in the treatment of bipolar disorder by investigating whether Subcallosal Cingulate (SCC) Deep Brain Stimulation (DBS) can safely and effectively treat treatment-resistant bipolar…
- Trial name
- NCT07745374
- Testing
- Medtronic Percept PC DBS system
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Bipolar I Disorder, Schizoaffective Disorder
Open Label Extension Study of NCT06221852
This is a 12-week open-label extension study for participants completing study NCT06221852.
- Conditions
- Bipolar I Disorder, Schizoaffective Disorder, Psychosis
- Trial name
- NCT06558201
- Testing
- Ketogenic diet
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mclean Hospital
Schizophrenia, Bipolar I Disorder
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
- Trial name
- NCT05303064
- Testing
- OLZ/SAM, Olanzapine
- Where
- 47 sites in United States, Argentina and 3 more
- Volunteers
- 220 people
- Sponsor
- Alkermes, Inc.
Bipolar I Disorder, Schizophrenia
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
- Trial name
- NCT04987229
- Testing
- OLZ/SAM
- Where
- 35 sites in United States, Argentina and 3 more
- Volunteers
- 236 people
- Sponsor
- Alkermes, Inc.
Bipolar Depression, Bipolar I Disorder
SYNCED - SYNChronized Eating in Bipolar Depression Study
Bipolar disorders (BD) are a group of complex disorders that impact mood, behaviour and cognition and are known to cause significant suffering and impairment.
- Conditions
- Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- NCT06560957
- Testing
- Time restricted eating, Eating ad libitum with nutritional counselling
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- University of Ottawa