Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
57 participants
INTERVENTIONAL
2011-09-30
2012-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
NCT01986101
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
NCT01986114
A Study to Evaluate the Efficacy of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
NCT01725308
Long-term Study of FK949E in Elderly Bipolar Disorder Patients
NCT01737268
The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder
NCT00719706
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm1: BMS-820836
Panels 1-4 are fixed dose panels (0.5, 1, 1 and 2 mg respectively), Panels 5-7 are titration dose panels (initiated at 1 mg and dose escalated to the target dose of 2 mg)
BMS-820836
Tablets, Oral, 0.5 mg, Once daily, 14 days
BMS-820836
Tablets, Oral, 1 mg, Once daily, 14 days
BMS-820836
Tablets, Oral, 2 mg, Once daily, 14 days
BMS-820836
Tablets, Oral, (initiated at 1 mg and dose escalated to the target dose of 2 mg), Once daily, 14 days
Arm 2: Placebo matching BMS-820836
Panels 1-4 are fixed dose panels (0.5, 1, 1 and 2 mg respectively), Panels 5-7 are titration dose panels (initiated at 1 mg and dose escalated to the target dose of 2 mg)
Placebo matching BMS-820836
Tablets, Oral, 0 mg, Once daily, 14 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BMS-820836
Tablets, Oral, 0.5 mg, Once daily, 14 days
BMS-820836
Tablets, Oral, 1 mg, Once daily, 14 days
BMS-820836
Tablets, Oral, 2 mg, Once daily, 14 days
Placebo matching BMS-820836
Tablets, Oral, 0 mg, Once daily, 14 days
BMS-820836
Tablets, Oral, (initiated at 1 mg and dose escalated to the target dose of 2 mg), Once daily, 14 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Non-compliance, or overall not suitable as determined by the investigator.
* History of, or current clinically significant psychiatric disorders or illnesses, substance abuse or dependence.
20 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution
Taito-Ku, Tokyo, Japan
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CN162-014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.