Depression Clinical Trial
Official title:
Adjunctive Lisdexamfetamine in Bipolar Depression
Verified date | March 2014 |
Source | Lindner Center of HOPE |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The specific aim of this study is to evaluate the efficacy and tolerability of lisdexamfetamine in the adjunctive treatment of bipolar disorder.
Status | Terminated |
Enrollment | 50 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Subjects will meet DSM-IV-TR criteria bipolar I or II disorder, Exclusion Criteria: - Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. - Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Lindner Center of HOPE | Mason | Ohio |
Lead Sponsor | Collaborator |
---|---|
Lindner Center of HOPE | Shire, University of Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in MADRS score | The primary efficacy variable is baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) score. | 30-36 months | Yes |
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