Clinical trials: Affective Psychosis, Bipolar
- Condition Affective Psychosis, Bipolar
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
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
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, 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
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
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, Schizophrenia
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
- Conditions
- Bipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder
- Trial name
- NCT06041646
- Testing
- Sublingual film containing Igalmi
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- BioXcel Therapeutics Inc
Bipolar Depression
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major…
- Trial name
- NCT03249376
- Testing
- Lumateperone
- Where
- 47 sites in United States, Bulgaria and 4 more
- Volunteers
- 381 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar Depression
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
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
- NCT00868699
- Testing
- lurasidone
- Where
- 55 sites in United States, Czechia and 6 more
- Volunteers
- 505 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar Depression
A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression
The main goal of this study is to help answer the following research question(s) and not to treat the child's illness. Can this study drug make children with bipolar depression feel better? Does this study drug work better than a…
- Trial name
- NCT00844857
- Testing
- Olanzapine Fluoxetine Combination (OFC)
- Where
- 7 sites in United States, Russia
- Volunteers
- 291 people
- Sponsor
- Eli Lilly and Company
Bipolar Disorder, Depression, Bipolar
Adjunctive Ziprasidone in the Treatment of Bipolar I Depression
The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression.
- Trial name
- NCT00483548
- Testing
- Ziprasidone
- Where
- 70 sites in United States, Australia and 1 more
- Volunteers
- 298 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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 I Disorder
A Multicenter, Investigative Study of the Safety and Efficacy of Extended Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
To assess the safety and efficacy of long-term administration of aripiprazole by performing extended administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner to those…
- Trial name
- NCT00606320
- Testing
- Aripiprazole
- Where
- 12 sites in China, Japan and 2 more
- Volunteers
- 59 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Depression, Bipolar
Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.
- Trial name
- NCT01396447
- Testing
- Cariprazine
- Where
- 88 sites in United States, Bulgaria and 4 more
- Volunteers
- 584 people
- Sponsor
- Forest Laboratories
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 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.
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
A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder
The purpose of this randomized, double blind, double dummy, multicenter study was to evaluate the efficacy of risperidone long-acting injectable (LAI) monotherapy in comparison with placebo in the prevention of a mood episode in…
- Trial name
- NCT00391222
- Testing
- Olanzapine, Risperidone Long Acting Injectable (LAI)
- Where
- 63 sites in China, Colombia and 13 more
- Volunteers
- 585 people
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
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
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
A Study of JNJ-55308942 in the Treatment of Bipolar Depression
The purpose of this study is to evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with bipolar disorder (BD) in a major depressive episode (MDE) at Week 6.
- Trial name
- NCT05328297
- Testing
- JNJ-55308942
- Where
- 44 sites in United States, Canada and 2 more
- Volunteers
- 116 people
- Sponsor
- Janssen Pharmaceutica N.V., Belgium