Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression

Sponsor

Lindner Center of HOPE (Other)

Overall Status

Terminated

CT.gov ID

NCT01131559

Collaborator

Shire (Industry), University of Cincinnati (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bipolar Depression	Drug: Lisdexamfetamine Drug: Placebo control	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Adjunctive Lisdexamfetamine in Bipolar Depression

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lisdexamfetamine Drug	Drug: Lisdexamfetamine Oral; 20-70mg/day Other Names: Vyvanse
Placebo Comparator: Placebo Drug	Drug: Placebo control Oral; 20-70mg/day Other Names: Sugar pill, fake pill with no active medication

Arm

Intervention/Treatment

Active Comparator: Lisdexamfetamine

Drug

Drug: Lisdexamfetamine

Oral; 20-70mg/day

Other Names:

Vyvanse

Placebo Comparator: Placebo

Drug

Drug: Placebo control

Oral; 20-70mg/day

Other Names:

Sugar pill, fake pill with no active medication

Outcome Measures

Primary Outcome Measures

Change in MADRS score [30-36 months]
The primary efficacy variable is baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.