Clinical trials: bipolar
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 I Disorder
A Study of Elpipodect (MK-8189) in Participants With Bipolar I Disorder (MK-8189-020)
The goal of this study is to evaluate the safety and tolerability of elpipodect in participants with stable bipolar I disorder. There was no hypothesis testing in this study.
- Trial name
- NCT06273774
- Testing
- Elpipodect
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Merck Sharp & Dohme LLC
Bipolar I Disorder
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
The primary objective of this trial is to evaluate the clinical efficacy and safety of aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a manic or mixed episode.
- Trial name
- NCT00606281
- Testing
- Aripiprazole
- Where
- 12 sites in China, Japan and 2 more
- Volunteers
- 258 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Bipolar Disorder
Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania
This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania.
- Trial name
- NCT00488618
- Testing
- Cariprazine (RGH-188)
- Where
- United States
- Volunteers
- 238 people
- Sponsor
- Forest Laboratories
Depression, Bipolar
Olanzapine Treatment of Patients With Bipolar I Disorder
The purpose of this study is to assess whether olanzapine is superior to placebo in patients with bipolar depression.
- Trial name
- NCT00510146
- Testing
- Olanzapine
- Where
- 16 sites in China, Japan and 1 more
- Volunteers
- 514 people
- Sponsor
- Eli Lilly and Company
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
Bipolar Disorder
40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)
The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or…
- Trial name
- NCT00145509
- Testing
- Asenapine
- Volunteers
- 77 people
- Sponsor
- Organon and Co
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.
Adolescent Schizophrenia, Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.
This is an open-label study consisting of a screening period, a conversion/titration phase (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period.
- Trial name
- ATTAIN 267 (NCT01122927)
- Testing
- Aripiprazole
- Where
- 101 sites in United States, Bulgaria and 11 more
- Volunteers
- 524 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder Mania
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.
- Trial name
- NCT00665366
- Testing
- Aripiprazole, Lithium, Valproate
- Where
- 73 sites in Austria, Czechia and 11 more
- Volunteers
- 493 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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 I
Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder
This will be an open-label uncontrolled trial to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar I disorder.
- Trial name
- ATLAS (NCT01710709)
- Testing
- Aripiprazole
- Where
- 142 sites in United States, Canada and 8 more
- Volunteers
- 748 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Acute Bipolar Mania
A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study
The primary objective of this study is to compare the efficacy of Seroquel XR monotherapy compared with Seroquel XR plus lithium in the treatment of acute bipolar mania by evaluation of the changes from baseline in Young Mania…
- Trial name
- STAR (NCT01254721)
- Testing
- Quetiapine fumarate, lithium
- Where
- 5 sites in South Korea
- Volunteers
- 131 people
- Sponsor
- AstraZeneca
Acute Mania, Bipolar Disorder, Manic
Ziprasidone And Olanzapine's Outcomes In Mania
The purpose of this study is to compare the efficacy and tolerability of ziprasidone versus olanzapine in the treatment of acute mania.
- Trial name
- ZOOM (NCT00329108)
- Testing
- ziprasidone hydrochloride, olanzapine
- Where
- 19 sites in Germany, Greece and 3 more
- Volunteers
- 29 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bipolar Disorder
An Evaluation Of BW430C (Lamotrigine) Versus Placebo In The Prevention Of Mood Episodes In Bipolar I Disorder Patients
This study is planned to objectively assess the efficacy and safety of lamotrigine maintenance therapy after symptoms of mood episode had been stabilised by open-label treatment with lamotrigine alone or in combination with other…
- Trial name
- NCT00550407
- Testing
- lamotrigine
- Where
- 60 sites in Japan
- Volunteers
- 215 people
- Sponsor
- GlaxoSmithKline
Bipolar I Disorder
A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients
Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I disorder.
- Trial name
- NCT00402324
- Testing
- olanzapine, divalproex
- Where
- United States
- Volunteers
- 202 people
- Sponsor
- Eli Lilly and Company
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
Bipolar Disorder
A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With 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
- NCT00282464
- Testing
- Geodon (Ziprasidone)
- Where
- 43 sites in United States
- Volunteers
- 392 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Congestive Heart Failure
Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar
The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead.
- Trial name
- CELESTIAL (NCT00810264)
- Testing
- CRT Therapy - LV Lead Registry
- Where
- 86 sites in United States
- Volunteers
- 2,499 people
- Sponsor
- Biotronik, Inc.
Bipolar Disorder
Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder
To evaluate the efficacy of ramelteon for treatment of acute depressive episodes associated with Bipolar 1 Disorder.
- Trial name
- NCT01677182
- Testing
- Ramelteon
- Where
- 104 sites in United States, Bulgaria and 8 more
- Volunteers
- 535 people
- Sponsor
- Takeda