Clinical trials: Acute Mania
Bipolar 1 Disorder
Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)
This trial will study the efficacy and safety of a fixed dose of asenapine in participants diagnosed with Bipolar 1 Disorder. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine…
- Trial name
- NCT00764478
- Testing
- Asenapine
- Volunteers
- 367 people
- Sponsor
- Organon and Co
Bipolar Disorder
Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With Acute Mania or Mixed Episodes
The primary objective of this study is to compare the efficacy and tolerability of quetiapine versus divalproex extended-release administered in a rapid oral loading fashion in the treatment of acute episodes of mania or mixed…
- Trial name
- NCT00397020
- Testing
- divalproex ER, quetiapine
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of California, San Diego
Bipolar Disorder
12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)
This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.
- Trial name
- NCT00145470
- Testing
- Asenapine
- Volunteers
- 326 people
- Sponsor
- Organon and Co
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
Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder
The primary study objective was to evaluate the dose-dependent efficacy of eslicarbazepine acetate administered at doses of 600, 1200, and 1800 mg over a 3-week period, compared with placebo, as therapy in patients with acute…
- Trial name
- NCT01824602
- Testing
- Eslicarbazepine acetate 1800 mg, Eslicarbazepine acetate 1200 mg, Eslicarbazepine acetate 600 mg
- Volunteers
- 38 people
- Sponsor
- Bial - Portela C S.A.
Bipolar Disorder, Mania
Safety and Efficacy of Cariprazine for Mania
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
- NCT01058096
- Testing
- Cariprazine
- Where
- 28 sites in United States, India
- Volunteers
- 323 people
- Sponsor
- Forest Laboratories
Acute Mania in Bipolar Disorder
Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder
To compare the efficacy and safety of quetiapine fumarate given as mono-therapy or adjunct therapy to lithium in the treatment of patients with acute mania in bipolar disorder.
- Trial name
- MANIA (NCT00672490)
- Testing
- Quetiapine Fumarate, Lithium
- Where
- 16 sites in China
- Volunteers
- 376 people
- Sponsor
- AstraZeneca
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
Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
The aim of this study is to investigate the efficacy, safety, and tolerability of iloperidone compared with placebo in treating acute manic or mixed episodes associated with Bipolar I Disorder.
- Trial name
- NCT04819776
- Testing
- Iloperidone
- Where
- 27 sites in United States, Bulgaria and 1 more
- Volunteers
- 417 people
- Sponsor
- Vanda Pharmaceuticals
Bipolar Disorder, Mania
Treatment of Bipolar Mania in Older Adults
This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.
- Trial name
- GERI-BD (NCT00254488)
- Testing
- Lithium (LI), Divalproex (DV)
- Where
- 8 sites in United States, Canada
- Volunteers
- 224 people
- Sponsor
- Weill Medical College of Cornell University
Bipolar Disorder
3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects
3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects
- Trial name
- NCT00312494
- Testing
- Ziprasidone
- Where
- 66 sites in United States
- Volunteers
- 680 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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 I Disorder, Acute Mania
A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
This study evaluated the safety and evaluate the safety and tolerability of open-label brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult subjects with bipolar I disorder.
- Trial name
- NCT03287869
- Testing
- Brexpiprazole
- Where
- 73 sites in United States, Bulgaria and 4 more
- Volunteers
- 381 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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 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.
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
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 Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)
Bipolar disorder is characterized by mood swings that range from from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes).
- Trial name
- NCT00159783
- Testing
- asenapine, Olanzapine
- Volunteers
- 218 people
- Sponsor
- Organon and Co
Schizophrenia, Mania
Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.
- Trial name
- NCT00102479
- Testing
- Aripiprazole
- Volunteers
- 21 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.