Overview

Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

Status:
Terminated

Trial end date:
2014-02-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Lindner Center of HOPE

Collaborators:

Shire
University of Cincinnati

Treatments:

Lisdexamfetamine Dimesylate

Criteria

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.