Overview

Adjunctive Lisdexamfetamine (LDX) in 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 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:

- 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.