Clinical trials: Bipolar Disorder I
Bipolar I Disorder
Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder.
Patients with bipolar I disorder (BD) experience depression 3 times more frequently than mania, and antidepressants are prescribed as adjuncts to mood stabilizers in up to 70% of patients.
- Trial name
- NCT00958633
- Testing
- Escitalopram, Bupropion XL
- Where
- Canada
- Volunteers
- 237 people
- Sponsor
- University of British Columbia
Bipolar I Disorder
Staccato Loxapine in Agitated Patients With Bipolar Disorder
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.
- Trial name
- NCT00721955
- Testing
- Inhaled loxapine 5 mg, Inhaled loxapine 10 mg
- Where
- 6 sites in United States
- Volunteers
- 314 people
- Sponsor
- Alexza Pharmaceuticals, Inc.
Bipolar Disorder
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
- Trial name
- NCT00277212
- Testing
- Lamotrigine + Aripiprazole
- Where
- 66 sites in United States, Puerto Rico
- Volunteers
- 1,169 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder, Major Depressive Episode
Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
The purpose of this study is to understand the efficacy of light therapy for bipolar depression.
- Trial name
- NCT00852592
- Testing
- 7000lux broad-spectrum light, 50lux dim red light
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Northwestern University
Schizophrenia, Schizoaffective Disorder
Targeting Cerebellum to Treat Psychosis: a Transcranial Magnetic Stimulation (TMS) Study
The goal of this study is to use transcranial magnetic stimulation (TMS) to investigate the impact of modulating cerebellar activity on time perception, executive function, and mood and psychotic symptoms in psychosis patients…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder I
- Trial name
- NCT02642029
- Testing
- Excitatory TMS, Inhibitory TMS
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mclean Hospital
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
Schizophrenia, Bipolar I Disorder
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1)
This study is an open label, sequential-group, two site, multiple dose escalating study of sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I disorder; in one study cohort (3a)…
- Trial name
- NCT01206517
- Testing
- Asenapine 2.5 mg, Asenapine 5 mg, Asenapine 10 mg
- Volunteers
- 30 people
- Sponsor
- Organon and Co
Bipolar Disorder
Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder
This 26-week open-label extension study is designed to provide information on the safety and tolerability of oral ziprasidone (20-80 mg BID (twice daily) with meals) during long-term administration in children and adolescents…
- Trial name
- NCT03768726
- Testing
- Ziprasidone
- Where
- 9 sites in United States
- Volunteers
- 23 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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 Disorder I, Bipolar Disorder II
A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode
This is an open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in the treatment of participants with bipolar I/II disorder with a current major depressive episode.
- Conditions
- Bipolar Disorder I, Bipolar Disorder II, Major Depressive Episode
- Trial name
- NCT03692910
- Testing
- SAGE-217
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Biogen
Bipolar I Disorder, Bipolar II Disorder
Gabapentin for Bipolar & Cannabis Use Disorders
The proposed 2-week, double-blind, crossover, proof of concept study aims to measure and manipulate core neurochemical (i.e., dysregulated brain GABA/glutamate homeostasis) and neurobehavioral (i.e., elevated impulsivity)…
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Cannabis Use Disorder, Substance Use Disorders
- Trial name
- NCT03334721
- Testing
- Gabapentin
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Medical University of South Carolina
Bipolar Depression
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.
- Trial name
- NCT01986101
- Testing
- SM-13496
- Where
- 8 sites in Japan, Lithuania and 6 more
- Volunteers
- 525 people
- Sponsor
- Sumitomo Pharma Co., Ltd.
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 Disorder
Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders
Children between the ages of 5-17 years old who have or display symptoms of emotional dysregulation (explosiveness, mood swings, irritability, and/or violent behavior) are invited to participate in a 12-week research study to…
- Trial name
- NCT02357290
- Testing
- Open-label Treatment with N-Acetylcysteine
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Massachusetts General Hospital
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
Effect of Pharmaceutical Care in Patients With Bipolar I Disorder (BD I)
This project aims, through pharmaceutical care in patients with Bipolar I Disorder, improve compliance and adherence rate, associated with greater effectiveness and safety of drug therapy to help achieve therapeutic goals, and…
- Trial name
- EMDADER-TABI (NCT01750255)
- Testing
- Pharmaceutical Care, Education
- Where
- Colombia
- Volunteers
- 92 people
- Sponsor
- Universidad de Antioquia
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.