Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression

Phase 3

Terminated

• Conditions: Bipolar; Depression
• Interventions: Drug: Lisdexamfetamine; 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

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-19
• Study First Submitted QC: 2010-05-26
• Study First Posted: 2010-05-27
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-04
• Last Update Posted: 2014-03-05

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.

Trial Locations

Locations (1)

Lindner Center of HOPE; 🇺🇸 Mason, Ohio, United States