Clinical trials: Manic
Bipolar Disorder
VALID : VAlproate Versus LIthium in Bipolar Disorders
Primary Objective : To compare the efficacy of valproate to lithium in Bipolar I patients suffering from a manic or a mixed episode according to DSM IV TR (APA 2000) [Diagnostic and Statistical Manual of Mental Disorders (DSM)…
- Trial name
- NCT00264173
- Testing
- Valproate sodium
- Volunteers
- 270 people
- Sponsor
- Sanofi
Sleep Initiation and Maintenance Disorders
A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients
A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug.
- Trial name
- NCT00374777
- Testing
- zolpidem MR, nitrazepam
- Where
- 6 sites in Japan
- Volunteers
- 450 people
- Sponsor
- Astellas Pharma Inc
Bipolar I Disorder, Manic or Mixed
Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents
To determine if long-term treatment, up to 6 months, with Depakote ER is safe and effective in the treatment of bipolar I disorder in children and adolescents.
- Trial name
- NCT00195767
- Testing
- divalproex sodium
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Abbott
Bipolar-I Disorder With Mania or Mania With Mixed Features
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
- Trial name
- BALSAM-1 (NCT06951698)
- Testing
- KarXT
- Where
- 74 sites in United States, Argentina and 7 more
- Volunteers
- 274 people
- Sponsor
- Bristol-Myers Squibb
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
Abilify in Bipolar Disorder for 6 Weeks Treatment Effectiveness
To demonstrate the efficacy and safety of co-administration of Abilify(aripiprazole) with Depakote(divalproate) in the acute phase of 6-week treatment of acute mania in patients with bipolar disorder.
- Trial name
- SMART-A (NCT00545142)
- Testing
- Abilify(Aripiprazole), Depakote(Divalproate)
- Where
- South Korea
- Volunteers
- 280 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Bipolar Disorder
3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)
Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes).
- Trial name
- NCT00159796
- Testing
- Asenapine, Olanzapine
- Volunteers
- 489 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
3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008)
Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes).
- Trial name
- NCT00159744
- Testing
- Asenapine, Olanzapine
- Volunteers
- 488 people
- Sponsor
- Organon and Co
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, Manic
Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with…
- Trial name
- NCT06462586
- Testing
- Lumateperone
- Where
- 42 sites in United States, Bulgaria and 3 more
- Volunteers
- 354 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar I Depression
A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression
The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms of bipolar I depression and to make sure it is safe in humans.
- Trial name
- NCT00812058
- Testing
- RG2417
- Where
- 36 sites in United States
- Volunteers
- 180 people
- Sponsor
- Repligen Corporation
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 Disorder
Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study
To assess the efficacy of Di-valproate in Bipolar I patients suffering from a manic episode according to DSM IV (APA 1994) over a 12 weeks period of treatment. To evaluate the clinical safety of Di-valproate.
- Trial name
- GEVANS (NCT00477373)
- Testing
- depakine chrono
- Where
- 4 sites in Bahrain, Kuwait and 2 more
- Volunteers
- 70 people
- Sponsor
- Sanofi
Mania, Schizophrenia
Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect
With this observational study we want to examine if the intensity of agitation, the intensity of psychotic symptoms and the presence of sleeping disorder predict the success of the treatment with a atypical antipsychotic after 12…
- Trial name
- UPTAQE (NCT00534222)
- Where
- 6 sites in Netherlands
- Volunteers
- 387 people
- Sponsor
- AstraZeneca
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.
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
Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder
The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar manic symptoms, when given once daily in the evening vs. twice daily.
- Trial name
- NCT00150553
- Testing
- Extended-release carbamazepine
- Volunteers
- 102 people
- Sponsor
- Validus Pharmaceuticals
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
A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder
The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who…
- Trial name
- NCT00490971
- Testing
- Olanzapine, Paliperidone ER
- Where
- 78 sites in United States, Bulgaria and 14 more
- Volunteers
- 768 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.