Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression
Information source: Lindner Center of HOPE
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar; Depression
Intervention: Lisdexamfetamine (Drug); Placebo control (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Lindner Center of HOPE
Summary
The specific aim of this study is to evaluate the efficacy and tolerability of
lisdexamfetamine in the adjunctive treatment of bipolar disorder.
Clinical Details
Official title: Adjunctive Lisdexamfetamine in Bipolar Depression
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in MADRS score
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Lindner Center of HOPE, Mason, Ohio 45040, United States
Additional Information
Link to facility where study is conducted
Starting date: January 2010
Last updated: March 4, 2014
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