Clinical trials: bipolar
Bipolar Disorder, Depression
Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder.
- Trial name
- NCT02670551
- Testing
- Cariprazine
- Where
- 74 sites in United States, Bulgaria and 4 more
- Volunteers
- 488 people
- Sponsor
- Forest Laboratories
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.
Bipolar I Disorder
Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients
This will be a randomized, double-blind, placebo-controlled trial to assess the time to recurrence of any mood episode in subjects with bipolar I disorder who have maintained stability on aripiprazole IM depot for at least 8…
- Trial name
- NCT01567527
- Testing
- Intramuscular (IM) Depot Aripiprazole
- Where
- 76 sites in United States, Canada and 5 more
- Volunteers
- 731 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Depression
Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.
- Trial name
- NCT00852202
- Testing
- cariprazine
- Where
- 26 sites in United States
- Volunteers
- 234 people
- Sponsor
- Forest Laboratories
Depression, Bipolar Disorder
Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression
The purpose of this study is to determine if a mobile sensing platform can passively and objectively detect the presence of clinically significant mood disorder symptomatology and symptom progression over time.
- Trial name
- NCT02742064
- Testing
- Cogito Companion Mobile Phone Application
- Where
- United States
- Volunteers
- 899 people
- Sponsor
- Cogito Health Inc
ADHD, Autism
Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders
A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to <13 years with CNS disorders.
- Conditions
- ADHD, Autism, Bipolar I Disorder, Conduct Disorder
- Trial name
- NCT03292848
- Testing
- Brexpiprazole
- Where
- 9 sites in United States
- Volunteers
- 24 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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.
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
Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions
The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fasting conditions using a…
- Trial name
- NCT00601536
- Testing
- Lithium
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Bipolar Disorder
Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions
The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fed…
- Trial name
- NCT00601575
- Testing
- Lithium
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Bipolar Disorder
Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions
The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fasting…
- Trial name
- NCT00602381
- Testing
- Lithium
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Bipolar Disorder
Bioequivalency Study of 300 mg Lithium Carbonate Under Fed Conditions
The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fed conditions using a single-dose…
- Trial name
- NCT00602394
- Testing
- Lithium
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Bipolar I Disorder
Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fed conditions.
- Trial name
- NCT01570894
- Testing
- Quetiapine Fumarate
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Treatment for Bipolar I Disorder
Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fasted conditions.
- Trial name
- NCT01570907
- Testing
- Quetiapine Fumarate
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Bipolar I Disorder
Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Steady State Fasted Conditions
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 300 mg Tablet under fasted steady state conditions.
- Trial name
- NCT01570959
- Testing
- Quetiapine Fumarate
- Where
- 7 sites in United States
- Volunteers
- 56 people
- Sponsor
- Roxane Laboratories
Bipolar I Depression
Lurasidone Pediatric Bipolar Study
A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression
- Trial name
- Illuminate (NCT02046369)
- Testing
- Lurasidone
- Where
- 66 sites in United States, Bulgaria and 9 more
- Volunteers
- 350 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar Depression, Bipolar Disorder
Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.
GSK1014802 is a use-dependent sodium channel blocker and an effective anticonvulsant in animal models. This study is being conducted to obtain information regarding the safety, tolerability and pharmacokinetics of repeated doses…
- Trial name
- NCT00908154
- Testing
- GSK1014802
- Where
- United Kingdom
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Biogen
Bipolar Disorder
GSK Drug Single Dose Escalation And Their Effect On Resting Motor Threshold In Healthy Volunteers
This is a First Time in Human Study to assess the safety, tolerability, pharmacokinetics and resting motor threshold (rMT) of single doses of GSK drug in healthy volunteers.This will be a 2 part and 2 centre study.Part 1 will be…
- Trial name
- NCT00488566
- Testing
- GSK drug, Lamictal
- Where
- 2 sites in United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Biogen
Bipolar Disorder
Oral Contraceptive Interaction Study for GW273225
GW273225 is in development for epilepsy and bipolar disorder and can affect women of child bearing potential. A clear understanding of the potential interaction between oral contraceptives and GW273225 is therefore important for…
- Trial name
- NCT00483535
- Testing
- GW273225, COC
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bipolar Disorder
Study to Assess the Effect of Food on the Concentration of GW273225 in the Body of Healthy Male and Female Volunteers
The rationale of this study is to assess whether or not food affects the absorption of GW273225 into the blood of healthy male and female volunteers in order to evaluate whether or not this drug should be given at a certain time…
- Trial name
- NCT00501865
- Testing
- GW273225
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline