Clinical trials: Depression Bipolar
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.
Psychotic Disorders, Schizophrenia
Parallel Group, Multiple Dose Pharmacokinetics Study of Five Antipsychotic Medications in Psychiatric Participants
The purpose of this study is to gather information about the steady-state plasma concentrations of aripiprazole, olanzapine, quetiapine and their relevant metabolites, at various dose levels and at different time points after…
- Conditions
- Psychotic Disorders, Schizophrenia, Bipolar Disorder, Depressive Disorder
- Trial name
- NCT02087579
- Testing
- Aripiprazole, oral formulation, Olanzapine, oral formulation, Paliperidone, oral formulation
- Where
- 24 sites in United States, Argentina and 5 more
- Volunteers
- 305 people
- Sponsor
- Janssen Research & Development, LLC
Bipolar Depression, Suicidal Ideation and Behavior
NRX-101 for Bipolar Depression With Subacute Suicidal Ideation
NMDA antagonist drugs have shown to reduce symptoms of depression and suicidal ideation. NeuroRx has developed NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for oral use in the treatment of bipolar depression…
- Trial name
- NCT03395392
- Testing
- NRX-101, Lurasidone HCl
- Where
- 14 sites in United States
- Volunteers
- 74 people
- Sponsor
- NeuroRx, Inc.
Schizophrenia, Bipolar I Disorder
Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine
The purpose of this study is to assess the PK, Safety, Tolerability (all cohorts) and Efficacy (cohort 3), of once-a-month long-acting SC injection of dose escalating Cariprazine Depot in subjects eligible for treatment with oral…
- Conditions
- Schizophrenia, Bipolar I Disorder, Major Depressive Disorder
- Trial name
- NCT07185815
- Testing
- Cariprazine Depot, Cariprazine Depot MTD, Oral Cariprazine 3 mg/day
- Where
- 6 sites in India, Israel
- Volunteers
- 24 people
- Sponsor
- Mapi Pharma Ltd.
Bipolar I Depression
Lurasidone Pediatric Bipolar Study
A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression
- Trial name
- Illuminate (NCT02046369)
- Testing
- Lurasidone
- Where
- 66 sites in United States, Bulgaria and 9 more
- Volunteers
- 350 people
- Sponsor
- Sumitomo Pharma America, Inc.
Depression
Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.
- Trial name
- NCT01121536
- Testing
- Armodafinil
- Where
- 158 sites in United States, Argentina and 15 more
- Volunteers
- 867 people
- Sponsor
- Cephalon
Depression
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major…
- Trial name
- NCT01305408
- Testing
- Armodafinil
- Where
- 130 sites in United States, Argentina and 12 more
- Volunteers
- 399 people
- Sponsor
- Cephalon
Schizophrenia, Major Depressive Disorder
Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
This study will assess the helpfulness of the integrated call center in optimizing use of the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder taking oral aripiprazole.
- Conditions
- Schizophrenia, Major Depressive Disorder, Bipolar I Disorder
- Trial name
- NCT02722967
- Testing
- Aripiprazole + IEM (Ingestible Event Marker)
- Where
- 4 sites in United States
- Volunteers
- 49 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Depression, Bipolar Disorder
A Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder
The purpose of this study is to evaluate the safety and effectiveness of quetiapine in actual clinical settings.
- Trial name
- NCT03403790
- Testing
- Quetiapine
- Where
- 47 sites in Japan
- Volunteers
- 369 people
- Sponsor
- Astellas Pharma Inc
Bipolar Depression
Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression
The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.
- Trial name
- NCT00926393
- Testing
- Quetiapine Immediate Release, Quetiapine Extended Release
- Volunteers
- 139 people
- Sponsor
- AstraZeneca
Depressive Episodes, Bipolar I Depression
A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).
This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression).
- Trial name
- NCT05227209
- Testing
- SEP-4199 CR
- Where
- 69 sites in United States, Bulgaria and 1 more
- Volunteers
- 64 people
- Sponsor
- Sumitomo Pharma America, Inc.
Depression in Patients With Bipolar Disorder
Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression
This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.
- Trial name
- NCT00622245
- Testing
- Lu AA34893, Quetiapine fumarate
- Where
- 50 sites in Australia, Austria and 16 more
- Volunteers
- 166 people
- Sponsor
- H. Lundbeck A/S
Schizophrenia, Bipolar 1 Disorder
A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder
The primary objective of this pragmatic clinical trial (Main Study) was to assess the difference between all-cause hospitalizations in participants using Abilify MyCite versus virtual matched controls.
- Conditions
- Schizophrenia, Bipolar 1 Disorder, Major Depressive Disorder
- Trial name
- NCT03643159
- Testing
- Abilify MyCite - Digital Medicine System, Aripiprazole or other oral antipsychotics
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder, Bipolar Depression
Seroquel in Bipolar Depression Versus Lithium
This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to…
- Conditions
- Bipolar Disorder, Bipolar Depression, Depression
- Trial name
- NCT00206141
- Testing
- Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)
- Where
- 76 sites in Canada, Croatia and 14 more
- Volunteers
- 672 people
- Sponsor
- AstraZeneca
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 Depression
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective…
- Trial name
- PREVAIL3 (NCT01284517)
- Testing
- Lurasidone
- Where
- 75 sites in United States, Canada and 8 more
- Volunteers
- 356 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar Disorder, Depression, Bipolar
Adjunctive Ziprasidone in the Treatment of Bipolar I Depression
The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression.
- Trial name
- NCT00483548
- Testing
- Ziprasidone
- Where
- 70 sites in United States, Australia and 1 more
- Volunteers
- 298 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bipolar I Disorder, Bipolar II Disorder
A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant 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 and 1.8% of the pediatric population in the United States.
- Trial name
- NCT06696755
- Testing
- Icalcaprant
- Where
- 33 sites in United States
- Volunteers
- 195 people
- Sponsor
- AbbVie
Bipolar Depression
Proof Of Mechanism Study To Determine Efficacy Of PF-04455242 In Blocking Spiradoline (PF-00345768) Stimulated Prolactin Release
This study will be a Proof of Mechanism (POM) study to establish evidence of central pharmacodynamic activity for PF 04455242, and will be a parallel group, randomized, double blind, sponsor open study conducted in healthy male…
- Trial name
- NCT00988949
- Testing
- PF-04455242, spiradoline
- Where
- Singapore
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Schizophrenia, Autism
Pediatric Open-Label Extension Study
This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have…
- Conditions
- Schizophrenia, Autism, Bipolar Depression
- Trial name
- NCT01914393
- Testing
- Lurasidone 20, 40, 60, 80 mg, flexibly dosed
- Where
- 88 sites in United States, Bulgaria and 13 more
- Volunteers
- 702 people
- Sponsor
- Sumitomo Pharma America, Inc.