Adults 18 to 74, any sex, with Bipolar Depression. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6Primary· Baseline to 6 weeks
Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.
The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.
Group
Value
95% CI
Placebo
-10.6
± 0.72
SM-13496 20 - 60 mg/Day
-13.6
± 0.69
SM-13496 80 - 120 mg/Day
-12.6
± 0.73
Change From Baseline in the CGI-BP-S (Depression) Score at Week 6Secondary· Baseline to 6 weeks
Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression.
The CGI depression score ranges from a minimum of 1 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
Group
Value
95% CI
Placebo
-1.11
± 0.092
SM-13496 20 - 60 mg/Day
-1.51
± 0.088
SM-13496 80 - 120 mg/Day
-1.41
± 0.093
Change From Baseline in the SDS Total Score at Week 6 (LOCF)Secondary· Baseline to 6 weeks
Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of functional impairment in work/school, social life and family life/home responsibilities.
The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
The SDS contains three (3) items. The total score is comput
Group
Value
95% CI
Placebo
-5.7
± 0.66
SM-13496 20 - 60 mg/Day
-7.6
± 0.62
SM-13496 80 - 120 mg/Day
-6.8
± 0.67
Change From Baseline in the YMRS Total Score at Week 6Secondary· Baseline to 6 weeks
YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder.
The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
The YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 ite
Group
Value
95% CI
Placebo
-0.51
± 0.190
SM-13496 20 - 60 mg/Day
-0.98
± 0.180
SM-13496 80 - 120 mg/Day
-0.99
± 0.191
Change From Baseline in the HAM-A Total Score at Week 6 (LOCF)Secondary· Baseline to 6 weeks
The Hamilton Rating Scale for Anxiety (HAM-A) scale is a rating scale developed to quantify the severity of anxiety symptomatology.
The HAM-A total score ranges from a minimum of 0 to a maximum of 56. For the HAM-A total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
The HAM-A contains fourteen (14) items. The total score is computed as the sum of the scores for the 14 items
Group
Value
95% CI
Placebo
-5.7
± 0.51
SM-13496 20 - 60 mg/Day
-7.4
± 0.49
SM-13496 80 - 120 mg/Day
-6.4
± 0.50
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT01986114 — A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sumitomo Pharma Co., Ltd.
Last refreshed: 12 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01986101.