At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 495 enrolled
Drug / intervention
SM-13496drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
In Brief
A Phase 3 clinical trial evaluating SM-13496 for Bipolar I Disorder. Completed, enrolled 495 participants across 8 sites in 8 countries.
Detailed Summary
The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Disorder
CountriesJapan, Lithuania, Malaysia, Philippines, Russia, Slovakia, Taiwan, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartJan 2014
Primary CompletionFeb 2018
Study CompletionFeb 2018
TodayJul 2026
First PostedNov 18, 2013
Enrollment StartJan 29, 2014
Primary CompletionFeb 8, 2018
Study CompletionFeb 17, 2018
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 12.6 years ago
Interventions
SM-13496drug