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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 April 2022 |
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Main ID: |
NCT01986101 |
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Date of registration:
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04/11/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
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Scientific title:
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A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression. |
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Date of first enrolment:
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February 19, 2014 |
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Target sample size:
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525 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01986101 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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China
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Japan
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Lithuania
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Malaysia
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Philippines
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Russian Federation
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Slovakia
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Taiwan
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Ukraine
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Contacts
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Name:
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Director, Drug Development Division |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sumitomo Pharma Co., Ltd. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
74 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bipolar Depression
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Intervention(s)
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Drug: Placebo
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Drug: SM-13496
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Primary Outcome(s)
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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
[Time Frame: Baseline to 6 weeks]
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Secondary Outcome(s)
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Change From Baseline in the YMRS Total Score at Week 6
[Time Frame: Baseline to 6 weeks]
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Change From Baseline in the CGI-BP-S (Depression) Score at Week 6
[Time Frame: Baseline to 6 weeks]
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Change From Baseline in the SDS Total Score at Week 6 (LOCF)
[Time Frame: Baseline to 6 weeks]
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Change From Baseline in the HAM-A Total Score at Week 6 (LOCF)
[Time Frame: Baseline to 6 weeks]
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Secondary ID(s)
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JapicCTI-132318
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D1002001
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2013-003038-34
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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