Clinical trials: Bipolar 1 Disorder
Bipolar Disorder
Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
The study will be a multi-center, parallel, group, placebo control, double-blind, randomized controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged 10 to 17 years) diagnosed with Bipolar I…
- Trial name
- NCT00723450
- Testing
- lamictal
- Where
- 46 sites in United States
- Volunteers
- 301 people
- Sponsor
- GlaxoSmithKline
Depression
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major…
- Trial name
- NCT01305408
- Testing
- Armodafinil
- Where
- 130 sites in United States, Argentina and 12 more
- Volunteers
- 399 people
- Sponsor
- Cephalon
Bipolar I Disorder, Mania
A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e.
- Conditions
- Bipolar I Disorder, Mania, Depression
- Trial name
- NCT03573297
- Testing
- Cariprazine
- Where
- 108 sites in United States, Bulgaria and 9 more
- Volunteers
- 901 people
- Sponsor
- AbbVie
Manic or Mixed Episode Associated With Bipolar I Disorder
Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder
The efficacy and safety of the extended treatment to patients with most recent episode manic or mixed who completed previous double blind study (F1D-JE-BMAC [Study BMAC]) will be examined.
- Trial name
- NCT00266630
- Testing
- olanzapine, lithium, valproate
- Where
- 11 sites in Japan
- Volunteers
- 139 people
- Sponsor
- Eli Lilly and Company
Major Depression, Bipolar I Disorder
The BIO-K Study: A Single-Arm, Open-Label, Biomarker Development Clinical Trial of Ketamine for Non-Psychotic Unipolar Major Depression and Bipolar I or II Depression.
The purpose of this research study is to find out if the medication known as ketamine can help the symptoms of depression. This drug is approved by the Food and Drug Administration (FDA) but the investigators will use it for a…
- Conditions
- Major Depression, Bipolar I Disorder, Bipolar II Disorder, Unipolar Depression
- Trial name
- Bio-K (NCT03156504)
- Testing
- Ketamine Hydrochloride
- Where
- 4 sites in United States
- Volunteers
- 75 people
- Sponsor
- Mayo Clinic
Depressive Episodes, Bipolar I Depression
A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).
This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression).
- Trial name
- NCT05227209
- Testing
- SEP-4199 CR
- Where
- 69 sites in United States, Bulgaria and 1 more
- Volunteers
- 64 people
- Sponsor
- Sumitomo Pharma America, Inc.
Psychosis, Schizophrenia
Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders
This clinical trial is a single center, single dose study of the acute effects of intranasal insulin on energy metabolism and cognitive function in patients with schizophrenia, schizoaffective and bipolar disorders, compared and…
- Conditions
- Psychosis, Schizophrenia, Schizo Affective Disorder, Bipolar I Disorder
- Trial name
- NCT03943537
- Testing
- Intranasal Insulin
- Where
- United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Mclean Hospital
Depressive Episode, Bipolar 1 Depression
A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression
A clinical study to test the effectiveness of an investigational drug to treat people that have major depressive episodes when they have Bipolar 1 Depression
- Trial name
- NCT03543410
- Testing
- SEP-4199 200 mg, SEP-4199 400 mg
- Where
- 87 sites in United States, Bulgaria and 6 more
- Volunteers
- 344 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar Disorder
A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes
The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.
- Trial name
- NCT00132678
- Testing
- Risperdal Consta
- Where
- 51 sites in United States, Austria and 8 more
- Volunteers
- 559 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bipolar Disorder
A Clinical Evaluation Of BW430C (Lamotrigine) In Bipolar I Disorder- Long-term Extension Of Study SCA104779 (NCT00550407) -
This study is planned to assess the long-term safety of lamotrigine in Japanese patients with bipolar I disorder who will continue into the 52-week extension upon completion of a double-blind comparative study (Study No.…
- Trial name
- NCT00566020
- Testing
- BW430C (lamotrigine)
- Where
- 52 sites in Japan
- Volunteers
- 92 people
- Sponsor
- GlaxoSmithKline
Bipolar I Disorder
This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296
This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of…
- Trial name
- PERSISTExt (NCT01575561)
- Testing
- Lurasidone
- Where
- 71 sites in United States, Argentina and 10 more
- Volunteers
- 377 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar Disorder
One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome
The purpose of this study is to explore the impact of Ziprasidone HCl on the distribution of metabolic syndrome (MS) risk factors in a population of Bipolar patients presenting with glucose intolerance, dyslipidemia and/or…
- Trial name
- NCT01113541
- Testing
- Ziprasidone HCL (oral)
- Where
- 10 sites in Canada
- Volunteers
- 13 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
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
Schizophrenia, Autism
Lurasidone Pediatric Pharmacokinetics Study
This is a Phase 1, open-label, multicenter, single and multiple ascending lurasidone dose study in subjects from 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric…
- Trial name
- NCT01620060
- Testing
- Lurasidone
- Where
- 10 sites in United States
- Volunteers
- 105 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar I Disorder
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.
- Trial name
- NCT01059539
- Testing
- Cariprazine
- Where
- 35 sites in United States, Hungary and 2 more
- Volunteers
- 403 people
- Sponsor
- Forest Laboratories
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.
Schizophrenia, Bipolar Disorder
Aripiprazole Open-Label, Safety and Tolerability Study
The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.
- Trial name
- APEX 241 (NCT00102518)
- Testing
- Aripiprazole
- Where
- 50 sites in United States
- Volunteers
- 325 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar 1 Disorder
Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder
The primary purpose of this study is to determine whether ELND005 is effective in the maintenance treatment of bipolar 1 disorder when added to other therapies.
- Trial name
- NCT01674010
- Testing
- ELND005, Lamotrigine, Valproic acid
- Where
- 82 sites in United States, Bulgaria and 7 more
- Volunteers
- 309 people
- Sponsor
- OPKO Health, Inc.
Bipolar I Disorder
A Study of Elpipodect (MK-8189) in Participants With Bipolar I Disorder (MK-8189-020)
The goal of this study is to evaluate the safety and tolerability of elpipodect in participants with stable bipolar I disorder. There was no hypothesis testing in this study.
- Trial name
- NCT06273774
- Testing
- Elpipodect
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Merck Sharp & Dohme LLC