Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression
Phase 3
Terminated
- Conditions
- BipolarDepression
- Interventions
- Drug: Placebo control
- Registration Number
- NCT01131559
- Lead Sponsor
- Lindner Center of HOPE
- Brief Summary
The specific aim of this study is to evaluate the efficacy and tolerability of lisdexamfetamine in the adjunctive treatment of bipolar disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lisdexamfetamine Lisdexamfetamine Drug Placebo Placebo control Drug
- Primary Outcome Measures
Name Time Method Change in MADRS score 30-36 months The primary efficacy variable is baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) score.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie LDX's efficacy in bipolar depression via dopamine/norepinephrine transporter modulation?
How does adjunctive LDX compare to standard-of-care antidepressants in bipolar depression treatment outcomes?
Which genetic or neuroimaging biomarkers predict response to adjunctive LDX in bipolar depression?
What are the known adverse events and management strategies for adjunctive LDX in bipolar depression?
What combination therapies or competitor drugs show promise as adjuncts for bipolar depression alongside LDX?
Trial Locations
- Locations (1)
Lindner Center of HOPE
🇺🇸Mason, Ohio, United States
Lindner Center of HOPE🇺🇸Mason, Ohio, United States