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Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression

Information source: Lindner Center of HOPE
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar; Depression

Intervention: Lisdexamfetamine (Drug); Placebo control (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Lindner Center of HOPE

Summary

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

Clinical Details

Official title: Adjunctive Lisdexamfetamine in Bipolar Depression

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in MADRS score

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Lindner Center of HOPE, Mason, Ohio 45040, United States
Additional Information

Link to facility where study is conducted

Starting date: January 2010
Last updated: March 4, 2014

Page last updated: August 23, 2015

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