Phase 3
N=525
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
Bipolar Depression
Bottom Line
View on ClinicalTrials.gov: NCT01986101 ↗Enrolled (actual)
525
Serious AEs
2.1%
Results posted
Jul 2019
Primary outcome: Primary: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 — -10.6; -13.6; -12.6 units on a scale — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); SM-13496 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma Co., Ltd.
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 |
-10.6; -13.6; -12.6 | 0.007 sig |
| SECONDARY Change From Baseline in the CGI-BP-S (Depression) Score at Week 6 |
-1.11; -1.51; -1.41 | 0.002 sig |
| SECONDARY Change From Baseline in the SDS Total Score at Week 6 (LOCF) |
-5.7; -7.6; -6.8 | 0.037 sig |
| SECONDARY Change From Baseline in the YMRS Total Score at Week 6 |
-0.51; -0.98; -0.99 | 0.076 |
| SECONDARY Change From Baseline in the HAM-A Total Score at Week 6 (LOCF) |
-5.7; -7.4; -6.4 | 0.016 sig |
Summary
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.
Eligibility Criteria
Inclusion Criteria
- Patients who were fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provided written voluntary consent to participate in the study.
- Outpatients aged 18 through 74 years at the time of consent
- Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
Exclusion Criteria
- Patients with imminent risk of suicide or injury to self, others, or property.
- Patients who had been hospitalized because of a manic or mixed episode within 60 days prior to screening.
- Patients who are otherwise considered ineligible for the study by the investigator.
Data sourced from ClinicalTrials.gov (NCT01986101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.