Clinical trials: Bipolar Depression Depressed Phase
Bipolar Depression, Major Depressive Disorder
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with Bipolar I or…
- Trial name
- NCT04285515
- Testing
- Lumateperone
- Where
- 42 sites in United States, Bulgaria and 3 more
- Volunteers
- 488 people
- Sponsor
- Intra-Cellular Therapies, 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 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
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
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 I Disorder
Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder.
- Trial name
- NCT00107731
- Testing
- quetiapine fumarate, lithium, divalproex
- Where
- 166 sites in United States, Australia and 16 more
- Volunteers
- 710 people
- Sponsor
- AstraZeneca
Bipolar Disorder, Depression
Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder
This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I…
- Trial name
- NCT02670538
- Testing
- Cariprazine
- Where
- 89 sites in United States, Bulgaria and 6 more
- Volunteers
- 493 people
- Sponsor
- Forest Laboratories
Bipolar Disorder, Depression
Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder.
- Trial name
- NCT02670551
- Testing
- Cariprazine
- Where
- 74 sites in United States, Bulgaria and 4 more
- Volunteers
- 488 people
- Sponsor
- Forest Laboratories
Affective Psychosis, Bipolar, Manic Disorder
Phase 3 /Seroquel SR Acute Mania Monotherapy - US
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks.
- Conditions
- Affective Psychosis, Bipolar, Manic Disorder, Manic-Depressive Psychosis, Mania
- Trial name
- NCT00422123
- Testing
- Quetiapine fumarate (Seroquel) SR
- Where
- 51 sites in United States
- Volunteers
- 447 people
- Sponsor
- AstraZeneca
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 I Disorder
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode
The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.
- Trial name
- NCT00094432
- Testing
- Aripiprazole
- Where
- 40 sites in United States
- Volunteers
- 650 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder
Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder.
- Trial name
- NCT00081380
- Testing
- Seroquel®, quetiapine fumarate (atypical antipsychotic), lithium (mood stabilizer), divalproex (mood stabilizer)
- Where
- 94 sites in United States, Canada
- Volunteers
- 710 people
- Sponsor
- AstraZeneca
Bipolar Disorder, Depression
A Study Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET (Positron Emission Tomography)
This is a subject blind, investigator and sponsor open, randomized study consisting of 2 parts. Up to 15 healthy subjects will be included in the study.
- Trial name
- NCT00939887
- Testing
- PF-04455242
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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.
Bipolar Disorder Depression
Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults
The goal of this clinical trial is to learn if ABX-002 added to participants' existing treatment(s) can improve clinical symptoms of depression and to learn about potential effects on brain chemistry that may correlate with…
- Trial name
- NCT06869187
- Testing
- ABX-002
- Where
- 14 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Autobahn Therapeutics, Inc.
Bipolar Disorder, Bipolar Depression
Seroquel in Bipolar Depression Versus SSRI
The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.
- Conditions
- Bipolar Disorder, Bipolar Depression, Depression
- Trial name
- EMBOLDEN II (NCT00119652)
- Testing
- quetiapine fumarate (Seroquel), paroxetine, mood stabilizing activity
- Where
- 55 sites in United States, Australia and 9 more
- Volunteers
- 676 people
- Sponsor
- AstraZeneca
Bipolar Depression
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar…
- Trial name
- NCT02600507
- Testing
- Lumateperone (ITI-007)
- Where
- 71 sites in United States, Bulgaria and 3 more
- Volunteers
- 529 people
- Sponsor
- Intra-Cellular Therapies, 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
Affective Psychosis, Bipolar, Depression, Bipolar
Phase III/Seroquel SR Bipolar Depression Monotherapy - US
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks.
- Conditions
- Affective Psychosis, Bipolar, Depression, Bipolar, Manic-Depressive Psychosis, Psychoses, Manic-Depressive
- Trial name
- NCT00422214
- Testing
- Quetiapine fumarate (Seroquel) SR
- Where
- 54 sites in United States
- Volunteers
- 400 people
- Sponsor
- AstraZeneca