Clinical trials: Manic
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 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
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
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
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, Pediatric
Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107)
Efficacy and safety of asenapine for the treatment of bipolar I disorder (manic or mixed episodes) will be evaluated in participants between 10 and 17 years old, who are either hospitalized or non-hospitalized.
- Trial name
- NCT01244815
- Testing
- asenapine, Rescue medication
- Volunteers
- 404 people
- Sponsor
- Organon and Co
Acute Mania
Adult Bipolar Mania
The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in treating acute mania and if so, how it…
- Trial name
- NCT00931723
- Testing
- Quetiapine fumarate XR, Lithium
- Where
- 65 sites in Belgium, Bulgaria and 7 more
- Volunteers
- 356 people
- Sponsor
- AstraZeneca
Bipolar Disorder
Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.
- Trial name
- NCT00129220
- Testing
- olanzapine, haloperidol
- Where
- 16 sites in Japan
- Volunteers
- 224 people
- Sponsor
- Eli Lilly and Company
Bipolar Disorder
Lamotrigine Phase III Study in Bipolar I Disorder
This registration study in China is a multi-centre, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of lamotrigine in the prevention of recurrence/relapse of mood episodes in subjects with…
- Trial name
- NCT01602510
- Testing
- Lamotrigine
- Where
- 21 sites in China
- Volunteers
- 265 people
- Sponsor
- GlaxoSmithKline
Bipolar I Disorder, Mania
A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e.
- Conditions
- Bipolar I Disorder, Mania, Depression
- Trial name
- NCT03573297
- Testing
- Cariprazine
- Where
- 108 sites in United States, Bulgaria and 9 more
- Volunteers
- 901 people
- Sponsor
- AbbVie
Bipolar I Disorder, Schizophrenia
Study in Adolescents With Schizophrenia or Bipolar Disorder
Open-label safety study of oral olanzapine treatment in adolescents, aged 13 to 17 years, with bipolar I disorder (manic or mixed episodes) or schizophrenia.
- Trial name
- NCT00982020
- Testing
- Olanzapine, Standard behavioral weight intervention, Intense behavioral weight intervention
- Where
- 14 sites in United States, Poland and 2 more
- Volunteers
- 203 people
- Sponsor
- Eli Lilly and Company
Bipolar Disorder
Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder
The purpose of this study is to determine if ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).
- Trial name
- NCT02075047
- Testing
- ziprasidone oral capsules
- Where
- 50 sites in United States, Ukraine
- Volunteers
- 171 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Mania, Bipolar I Disorder
Safety and Efficacy of Cariprazine for Bipolar I Disorder
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.
- Trial name
- NCT01058668
- Testing
- Cariprazine
- Where
- 66 sites in United States, Croatia and 4 more
- Volunteers
- 497 people
- Sponsor
- Forest Laboratories
Bipolar I Disorder
Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder
Multicentre, double-blind, randomised, parallel-group, placebo-controlled dose-titration study; depending on clinical efficacy, up-titration of dosage 3 and 6 days after start of treatment; maintenance of individual maximum dose…
- Trial name
- NCT01822678
- Testing
- Eslicarbazepine Acetate
- Volunteers
- 161 people
- Sponsor
- Bial - Portela C S.A.
Bipolar I Disorder
A Multicenter, Placebo-controlled, Double-blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
To investigate the safety and efficacy of long-term administration of aripiprazole by performing extended administration of the treatment administered in the preceding multicenter, double-blind, placebo-controlled, parallel…
- Trial name
- NCT00606177
- Testing
- Aripiprazole
- Where
- 12 sites in China, Japan and 2 more
- Volunteers
- 99 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Bipolar I Disorder, Manic Episode
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder
To demonstrate the efficacy of brexpiprazole for the acute treatment of manic episodes, with or without mixed features, in participants with a diagnosis of bipolar I disorder.
- Trial name
- NCT03259555
- Testing
- Brexpiprazole
- Where
- 48 sites in United States, Bulgaria and 2 more
- Volunteers
- 322 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.