Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Bipolar Depression

In brief

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

Key facts

Study ID

NCT01093963

Run by

Lindner Center of HOPE

People needed

25

Starts

2010-01-01

Expected to finish

2014-02-01

Last updated by the study team

2015-09-02

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Lindner Center of HOP — Mason, Ohio, United States

Full record on ClinicalTrials.gov

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