Clinical trials: Bipolar I Disorder
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.
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
Major Depressive Episode, Bipolar Depression
NeoSync TMS Treatment for Bipolar I Depression
This study is designed to evaluate the safety and preliminary efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Bipolar Disorder type I in a…
- Conditions
- Major Depressive Episode, Bipolar Depression, Bipolar Disorder, Mood Disorders
- Trial name
- NESTTBID (NCT02839798)
- Testing
- NEST (NeoSync EEG Synchronized TMS)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Butler Hospital
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
Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
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
- NCT00868959
- Testing
- lurasidone
- Where
- 151 sites in United States, Canada and 13 more
- Volunteers
- 817 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar I Disorder
Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder
Multicentre, double-blind, randomised, parallel-group, placebo-controlled dose-titration study; depending on clinical efficacy, up-titration of dosage 3 and 6 days after start of treatment; maintenance of individual maximum dose…
- Trial name
- NCT01822678
- Testing
- Eslicarbazepine Acetate
- Volunteers
- 161 people
- Sponsor
- Bial - Portela C S.A.
Bipolar I Disorder, Schizophrenia
Study in Adolescents With Schizophrenia or Bipolar Disorder
Open-label safety study of oral olanzapine treatment in adolescents, aged 13 to 17 years, with bipolar I disorder (manic or mixed episodes) or schizophrenia.
- Trial name
- NCT00982020
- Testing
- Olanzapine, Standard behavioral weight intervention, Intense behavioral weight intervention
- Where
- 14 sites in United States, Poland and 2 more
- Volunteers
- 203 people
- Sponsor
- Eli Lilly and Company
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
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 Depression, Bipolar I Disorder
iTBS in Bipolar I Depression
A multisite, open label pilot study to investigate the efficacy and safety of a novel accelerated intermittent theta-burst stimulation (iTBS) protocol while assessing for changes in neuroimaging biomarkers associated with…
- Trial name
- NCT05375214
- Testing
- Magnus Transcranial Magnetic Neuromodulation System (MNS) with SAINT®(Stanford Accelerated Intelligent Neuromodulation Therapy)
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Johns Hopkins University
Bipolar I Disorder
Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed
To assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar I disorder, depressed.
- Trial name
- NCT00618748
- Testing
- Olanzapine
- Where
- 10 sites in Japan
- Volunteers
- 101 people
- Sponsor
- Eli Lilly and Company
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.
Bipolar Disorder, Mania
Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder
The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder.
- Trial name
- NCT00181844
- Testing
- lamotrigine
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Massachusetts General Hospital
Bipolar Disorder
A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression
This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed.
- Trial name
- NCT00141271
- Testing
- Geodon (Ziprasidone)
- Where
- 72 sites in United States
- Volunteers
- 536 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bipolar Disorder
Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania
This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania.
- Trial name
- NCT00488618
- Testing
- Cariprazine (RGH-188)
- Where
- United States
- Volunteers
- 238 people
- Sponsor
- Forest Laboratories
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, 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
Bipolar Disorder, Pediatric
Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107)
Efficacy and safety of asenapine for the treatment of bipolar I disorder (manic or mixed episodes) will be evaluated in participants between 10 and 17 years old, who are either hospitalized or non-hospitalized.
- Trial name
- NCT01244815
- Testing
- asenapine, Rescue medication
- Volunteers
- 404 people
- Sponsor
- Organon and Co