Clinical trials: Bipolar II Disorder
Bipolar Depression
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant bipolar depression (TRBD).
- Trial name
- NCT03965871
- Testing
- Esketamine DPI - low dose, Esketamine DPI - medium dose, Esketamine DPI - high dose
- Where
- 12 sites in Poland
- Volunteers
- 88 people
- Sponsor
- Celon Pharma SA
Bipolar Disorder
Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling
The purpose of the study is to evaluate the efficacy of quetiapine compared to valproate during a 12 month treatment period in subjects with Bipolar Disorder I or II with Rapid Cycling.
- Trial name
- NCT00254774
- Testing
- quetiapine fumarate or valproate
- Where
- 3 sites in Germany
- Volunteers
- 44 people
- Sponsor
- AstraZeneca
Bipolar Disorder
The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Bipolar Disorder I or II This Study is Not Being Conducted in the United States.
Bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania, grandiose delusions, and suicidality. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of patients with…
- Trial name
- NCT00154323
- Testing
- Oxcarbazepine
- Volunteers
- 55 people
- Sponsor
- Novartis
Bipolar I Disorder, Bipolar II Disorder
Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder
This open-label study will utilize treatment with BXCL501 in order to assess the suitability of patient-and lay informant-assessed outcome measures for evaluation of severity of psychomotor agitation episodes in patients with…
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder
- Trial name
- NCT07116694
- Testing
- BXCL501 Sublingual Film
- Where
- 5 sites in United States
- Volunteers
- 33 people
- Sponsor
- BioXcel Therapeutics Inc
Bipolar Depression
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B.
- Trial name
- NCT02600494
- Testing
- ITI-007 (Lumateperone)
- Where
- 55 sites in United States
- Volunteers
- 554 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar Depression
Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression
The primary purpose of this study is to determine the safety and efficacy of oral RG2417 (Uridine) when administered to patients with Bipolar I depression twice daily for six weeks.
- Trial name
- NCT00322764
- Testing
- Uridine
- Where
- 11 sites in United States
- Volunteers
- 80 people
- Sponsor
- Repligen Corporation
Bipolar Disorder, Bipolar Depression
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a…
- Conditions
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- X-CEED (NCT07172516)
- Testing
- Azetukalner
- Where
- 44 sites in United States, Bulgaria and 2 more
- Volunteers
- 400 people
- Sponsor
- Xenon Pharmaceuticals Inc.
Major Depressive Disorder, Bipolar I and Bipolar II
Bipolar Proteomic Assay Validation Study
The purpose of this study is to validate a set of signatures, based on a panel of proteomic markers, that discriminate BDI, BDII, and MDD in people seeking treatment for a depressive episode.
- Trial name
- NCT02746367
- Testing
- Diagnostic test (LDT)
- Where
- 5 sites in United States
- Volunteers
- 261 people
- Sponsor
- Myriad Genetic Laboratories, Inc.
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
Bipolar Disorder
A Study Evaluating the Efficacy of Administered Maintenance Treatments in Bipolar Disorder I and II.
The primary objective of the study is to evaluate the efficacy of administered maintenance treatments in bipolar disorder I and II, defined as the percentage of patients who experience a relapse episode during the first 9 months…
- Trial name
- NCT01202604
- Where
- 33 sites in Greece
- Volunteers
- 294 people
- Sponsor
- AstraZeneca
Major Depressive Disorder, Bipolar 1 Disorder
Efficacy of the Mobile Application for Prediction and Prevention of Mood Episode Recurrence Based on Machine Learning
This study was designed to evaluate the efficacy of the mobile application named Circadian Rhythm for Mood (CRM), which was developed to prevent recurring episodes of mood disorders (major depressive disorders, bipolar disorders…
- Conditions
- Major Depressive Disorder, Bipolar 1 Disorder, Bipolar II Disorder
- Trial name
- NCT05400785
- Testing
- Circadian Rhythms for Mood (CRM) application - Active
- Where
- South Korea
- Volunteers
- 93 people
- Sponsor
- Hucircadian
Bipolar Disorder I or II
Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine
A non randomized study to validate the MATHYS Scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and treated with olanzapine.
- Trial name
- NCT00259272
- Testing
- olanzapine
- Where
- 16 sites in France
- Volunteers
- 141 people
- Sponsor
- Eli Lilly and Company
Schizophrenia, Major Depressive Disorder (MDD)
A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple dose oral administration of SEP-380135 in participants with schizophrenia or with a major depressive…
- Conditions
- Schizophrenia, Major Depressive Disorder (MDD), Bipolar Disorder
- Trial name
- NCT07549581
- Testing
- SEP-380135
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Episode Associated With Bipolar II Disorder
To Evaluate the Effects of NMRA-335140 on Symptoms of Major Depression in Participants With Bipolar II Disorder.
This is a randomized, double-blind, placebo-controlled pilot study aiming to evaluate the effects of NMRA-335140 on symptoms of major depression in adults with Bipolar (BP) II disorder.
- Trial name
- NCT06429722
- Testing
- NMRA-335140 80 mg
- Where
- 21 sites in United States
- Volunteers
- 18 people
- Sponsor
- Neumora Therapeutics, Inc.
Bipolar II Disorder
Phase 2 Clinical Trial of GH001 in Bipolar II Disorder
This study is a multicenter, open-label, single-arm Phase 2 clinical trial. Approximately 15 participants with clinically diagnosed bipolar disorder (BD) type II and experiencing a current episode of depression will be included…
- Trial name
- NCT05839509
- Testing
- GH001
- Where
- 7 sites in Germany, Netherlands and 1 more
- Volunteers
- 6 people
- Sponsor
- GH Research Ireland Limited
Bipolar Depression, Bipolar I Disorder
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
X-CEED-OLE is a Phase 3, multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner in adult participants who successfully completed an antecendent Phase 3 azetukalner bipolar…
- Conditions
- Bipolar Depression, Bipolar I Disorder, Bipolar Disorder, Bipolar II Disorder
- Trial name
- NCT07217860
- Testing
- Azetukalner
- Where
- 20 sites in United States
- Volunteers
- 400 people
- Sponsor
- Xenon Pharmaceuticals Inc.
Bipolar I Disorder, Bipolar II Disorder
Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. This study will assess how safe and effective ABBV-932 is in treating participants with bipolar I or II…
- Trial name
- CANTO (NCT06605599)
- Testing
- ABBV-932
- Where
- 40 sites in United States, Japan and 1 more
- Volunteers
- 161 people
- Sponsor
- AbbVie
Bipolar Disorders
A NIS Evaluating the Treatment Patterns of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II Disorder
The purpose of this NIS is to obtain data on how AAPs are used in DSM-IV-TR Bipolar I and II Disorder, in the course of a major depressive episode.
- Trial name
- HARMONY (NCT00888264)
- Where
- 45 sites in Belgium
- Volunteers
- 152 people
- Sponsor
- AstraZeneca
Depression, Bipolar
A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
This is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or…
- Trial name
- APOLLO (NCT03423680)
- Testing
- Abilify 2, 5, 10, 15mg (Tablet)
- Where
- South Korea
- Volunteers
- 390 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Bipolar Disorder I, Bipolar Disorder II
A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode
This is an open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in the treatment of participants with bipolar I/II disorder with a current major depressive episode.
- Conditions
- Bipolar Disorder I, Bipolar Disorder II, Major Depressive Episode
- Trial name
- NCT03692910
- Testing
- SAGE-217
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Biogen