Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-02-28

Brief Summary

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

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Detailed Description

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Conditions

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Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lisdexamfetamine

Drug

Group Type ACTIVE_COMPARATOR

Lisdexamfetamine

Intervention Type DRUG

oral; 20-70mg/day

Placebo

Drug

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral; 20-70mg/day

Interventions

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Lisdexamfetamine

oral; 20-70mg/day

Intervention Type DRUG

Placebo

oral; 20-70mg/day

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes