Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

Phase 3

Terminated

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

• Registration Number: NCT01093963
• Lead Sponsor: Lindner Center of HOPE

Brief Summary

The specific aim of this study is to evaluate the efficacy and tolerability of a stimulant (lisdexamfetamine) in the adjunctive treatment of bipolar disorder.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-26
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Men and women, through the ages of 18 and 55 years, inclusive.

Exclusion Criteria

• Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures.
• Subjects who are displaying clinically significant homicidality or suicidality
• 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
Placebo	Placebo	Drug
Lisdexamfetamine	Lisdexamfetamine	Drug

Primary Outcome Measures

Name	Time	Method
Change in the Montgomery-Asberg Depression Rating Scale	30-36 months	Efficacy will be assessed by measuring the baseline-to-endpoint change in the Montgomery-Asberg Depression Rating Scale (MADRS)

Trial Locations

Locations (1)

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