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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: |
NCT01986114 |
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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 Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
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Scientific title:
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A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder. |
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Date of first enrolment:
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January 29, 2014 |
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Target sample size:
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495 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01986114 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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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 completed the D1002001 study
·Patients who completed the D1002001 study and who are considered by the investigator to be
eligible and without safety concerns.
Patients who did not participate in the D1002001 study
- 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 manic,
hypomanic, or mixed with or without rapid cycling disease course (= 4 episodes of mood
disturbance, but < 8 episodes in the previous 12 months prior to screening).
Exclusion Criteria:
- Patients with imminent risk of suicide or injury to self, others, or property.
- 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 I Disorder
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Intervention(s)
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Drug: SM-13496
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Primary Outcome(s)
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Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR)
[Time Frame: 28, 52 weeks]
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Secondary Outcome(s)
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Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
[Time Frame: Baseline, 52 weeks and each month]
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Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score.
[Time Frame: Baseline, 52 weeks and each month]
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Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder.
[Time Frame: Baseline to 52 weeks]
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Secondary ID(s)
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D1002002
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2013-003039-31
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JapicCTI-132319
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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