Clinical trials: Bipolar and Related Disorders
- Condition Bipolar and Related Disorders
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Bipolar Disorder, Bipolar Affective Psychosis
Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder.
The primary purpose of the study is to assess the efficacy of Quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to Bipolar disorder.
- Conditions
- Bipolar Disorder, Bipolar Affective Psychosis, Mania, Manic Disorder
- Trial name
- EMMY (NCT00521365)
- Testing
- Quetiapine 600mg
- Where
- 7 sites in Mexico
- Volunteers
- 88 people
- Sponsor
- AstraZeneca
Bipolar Disorder
One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome
The purpose of this study is to explore the impact of Ziprasidone HCl on the distribution of metabolic syndrome (MS) risk factors in a population of Bipolar patients presenting with glucose intolerance, dyslipidemia and/or…
- Trial name
- NCT01113541
- Testing
- Ziprasidone HCL (oral)
- Where
- 10 sites in Canada
- Volunteers
- 13 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bipolar Depression, Suicidal Ideas
Sequential Therapy for the Treatment of Severe Bipolar Depression.
NeuroRx is developing NRX-101, a fixed-dose combination oral capsule composed of d-cycloserine (DCS) and lurasidone for the maintenance of remission from Severe Bipolar Depression with Acute Suicidal Ideation (C-SSRS level 4 or…
- Conditions
- Bipolar Depression, Suicidal Ideas, Suicidal Ideation, Suicide, Attempted
- Trial name
- STABIL-B (NCT02974010)
- Testing
- NRX-101 Oral Capsule, Lurasidone Oral Capsule, Ketamine Intravenous Infusion
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- NeuroRx, Inc.
Schizophrenia, Bipolar Disorder
Aripiprazole Open-Label, Safety and Tolerability Study
The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.
- Trial name
- APEX 241 (NCT00102518)
- Testing
- Aripiprazole
- Where
- 50 sites in United States
- Volunteers
- 325 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Depression
Study Comparing Outcomes for Patients With Treatment Resistant Depression Who Receive VNS Therapy at Different Doses
This is a postmarket medical device study. The objective of this study is to compare the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy administered at different amounts of electrical charge for the treatment…
- Trial name
- NCT00305565
- Testing
- VNS Therapy
- Where
- 26 sites in United States
- Volunteers
- 331 people
- Sponsor
- Cyberonics, Inc.
Agitation Associated With Bipolar Disorder, Agitation,Psychomotor
Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder.
- Conditions
- Agitation Associated With Bipolar Disorder, Agitation,Psychomotor, Bipolar Disorder
- Trial name
- SERENITY II (NCT04276883)
- Testing
- Sublingual film containing Dexmedetomidine (BXCL501)
- Where
- 15 sites in United States
- Volunteers
- 380 people
- Sponsor
- BioXcel Therapeutics Inc
Bipolar Disorder
A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes
The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.
- Trial name
- NCT00132678
- Testing
- Risperdal Consta
- Where
- 51 sites in United States, Austria and 8 more
- Volunteers
- 559 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
Bipolar Depression
Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
The primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(XR) mono-therapy, administered once daily compared to placebo, in the treatment of depressive symptoms in patients with…
- Trial name
- NCT01256177
- Testing
- Quetiapine Fumarate (SEROQUEL) Extended Release
- Where
- 12 sites in China
- Volunteers
- 361 people
- Sponsor
- AstraZeneca
Bipolar Disorder
Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder
The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in adult patients.
- Trial name
- NCT01467713
- Testing
- Ramelteon SL
- Where
- 156 sites in United States, Argentina and 3 more
- Volunteers
- 642 people
- Sponsor
- Takeda
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
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 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 Disorder
Aripiprazole in Children and Adolescents With Bipolar I Disorder
The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.
- Trial name
- NCT00110461
- Testing
- Aripiprazole
- Where
- 53 sites in United States
- Volunteers
- 296 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Epilepsy, Bipolar Disorder
Lamotrigine Pregnancy Registry (LAM05)
Antiepileptic drugs (AEDs) are not indicated for use in pregnancy. However, women with epilepsy, and other approved indications including bipolar disorder, may require or be unintentionally exposed to AEDs during pregnancy.
- Trial name
- NCT01064297
- Testing
- Lamotrigine monotherapy, Lamotrigine polytherapy including valproate, Lamotrigine polytherapy without valproate
- Volunteers
- 3,416 people
- Sponsor
- GlaxoSmithKline
Bipolar Disorder
Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)
This study will investigate the safety and tolerability of a flexible dosing regimen of asenapine for the long-term treatment of manic or mixed episodes associated with bipolar disorder I in children and adolescents who completed…
- Trial name
- ADDRESS-98 (NCT01349907)
- Testing
- Asenapine, Rescue medication
- Volunteers
- 322 people
- Sponsor
- Organon and Co
Bipolar Disorder
An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder
The precursor study (SCA101469) was an open-label, prospective multicentre study in adult subjects diagnosed with bipolar disorder consisting of 36 weeks treatment with lamotrigine.
- Trial name
- NCT00360126
- Testing
- lamotrigine
- Where
- 3 sites in Australia
- Volunteers
- 11 people
- Sponsor
- GlaxoSmithKline
Bipolar Disorder
A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression
This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed.
- Trial name
- NCT00141271
- Testing
- Geodon (Ziprasidone)
- Where
- 72 sites in United States
- Volunteers
- 536 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bipolar Depression
Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression
- Trial name
- NCT00868959
- Testing
- lurasidone
- Where
- 151 sites in United States, Canada and 13 more
- Volunteers
- 817 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar Disorder
Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
The study will be a multi-center, parallel, group, placebo control, double-blind, randomized controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged 10 to 17 years) diagnosed with Bipolar I…
- Trial name
- NCT00723450
- Testing
- lamictal
- Where
- 46 sites in United States
- Volunteers
- 301 people
- Sponsor
- GlaxoSmithKline