Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression

Lindner Center of HOPE

Status and phase: Terminated; Phase 3

Conditions: Depression; Bipolar

Treatments: Drug: Placebo control; Drug: Lisdexamfetamine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01131559

Adjunctive LDX in BP

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 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 control