Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

Lindner Center of HOPE

Status and phase: Terminated; Phase 3

Conditions: Bipolar Depression

Treatments: Drug: Placebo; Drug: Lisdexamfetamine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01093963

LDX BP

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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25 participants in 2 patient groups, including a placebo group

Lisdexamfetamine

Active Comparator group

Description:

Drug

Treatment:

Drug: Lisdexamfetamine

Placebo

Placebo Comparator group

Description:

Drug

Treatment:

Drug: Placebo