Clinical trials: Bipolar and Related Disorders
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
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
Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4451
This is a single ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD4451.
- Trial name
- AZD4451 SAD (NCT01196676)
- Testing
- AZD4451
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Affective Psychosis, Bipolar, Manic Disorder
Phase 3 /Seroquel SR Acute Mania Monotherapy - US
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks.
- Conditions
- Affective Psychosis, Bipolar, Manic Disorder, Manic-Depressive Psychosis, Mania
- Trial name
- NCT00422123
- Testing
- Quetiapine fumarate (Seroquel) SR
- Where
- 51 sites in United States
- Volunteers
- 447 people
- Sponsor
- AstraZeneca
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
Schizophrenia, Bipolar Disorder
Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar Disorder
This is a multicenter,open-label,prospective study of Aripiprazole use in patients with schizophrenia and bipolar disorder.
- Trial name
- NCT00216723
- Testing
- Aripiprazole
- Where
- 2 sites in South Korea
- Volunteers
- 3,000 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Bipolar Disorder
9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)
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
- NCT00143182
- Testing
- Asenapine, Olanzapine
- Volunteers
- 504 people
- Sponsor
- Organon and Co
Bipolar Disorder
Evaluation of Patient Characteristics and Treatment Approaches to Patients With Bipolar Disorder in Turkey
A registry study to identify the patient-diagnosis-treatment characteristic profile of patients with bipolar disorder in Turkey.
- Trial name
- NCT00660712
- Where
- 19 sites in Turkey (Türkiye)
- Volunteers
- 1,018 people
- Sponsor
- AstraZeneca
Bipolar Disorders
Open-label Adjunctive Zonisamide for Bipolar Disorder
To study the safety and efficacy of zonisamide as adjunctive therapy for children and adolescents with bipolar I or II disorder.
- Trial name
- NCT00047567
- Testing
- zonisamide
- Volunteers
- 20 people
- Sponsor
- Elan Pharmaceuticals
Bipolar Disorder, Schizophrenia
A Non-interventional Naturalistic Project to Investigate the Effect of the Use of SMS Text Service on Treatment Adherence in Patients Treated With Seroquel® (Quetiapine)
The basic hypothesis of this trial is that forgetfulness and failure to establish a routine that facilitates medication adherence are prominent reasons for non-adherence.
- Trial name
- SEQUEL (NCT00533260)
- Where
- 35 sites in Netherlands
- Volunteers
- 128 people
- Sponsor
- AstraZeneca
Bipolar Disorder
Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode
The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.
- Trial name
- NCT00080314
- Testing
- Aripiprazole
- Where
- 28 sites in United States
- Volunteers
- 400 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, 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 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 Depression
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective…
- Trial name
- PREVAIL3 (NCT01284517)
- Testing
- Lurasidone
- Where
- 75 sites in United States, Canada and 8 more
- Volunteers
- 356 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar Depression, Suicidal Ideation
NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation
NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression and suicidal ideation. NeuroRx has developed a sequential therapy consisting of IV NRX-100 (ketamine HCL) for rapid stabilization of…
- Trial name
- SBD-ASIB (NCT03396068)
- Testing
- NRX-101, Lurasidone HCl
- Where
- 4 sites in United States
- Volunteers
- 72 people
- Sponsor
- NeuroRx, Inc.
Bipolar Disorder
Depressive Symptoms in Acute Manic Episode
Observational, non-interventional, transversal, multicenter, open label (No treatment is involved). The primary objective is to detect the prevalence of depressive symptoms in bipolar patients admitted to a psychiatric Unit due…
- Trial name
- MM1 (NCT00690248)
- Where
- 34 sites in Spain
- Volunteers
- 250 people
- Sponsor
- AstraZeneca
Bipolar Disorder
Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects
This Pharmacokinetic (PK) study is going to provide supplemental PK data for supporting bipolar Phase III study for New Drug Application (NDA) filing according to regulatory requirement.
- Trial name
- NCT02513654
- Testing
- Lamotrigine
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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 Disorder
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms.
- Trial name
- NCT07286175
- Testing
- Brenipatide
- Where
- 87 sites in United States, Argentina and 6 more
- Volunteers
- 400 people
- Sponsor
- Eli Lilly and Company
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