Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

Adjunctive Lisdexamfetamine in Bipolar Depression

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01093963

Enrollment

Registered

2010-03-26

Start date

2010-01-31

Completion date

2014-02-28

Last updated

2015-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Depression

Brief summary

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

Interventions

DRUGLisdexamfetamine

oral; 20-70mg/day

DRUGPlacebo

oral; 20-70mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in the Montgomery-Asberg Depression Rating Scale	30-36 months	Efficacy will be assessed by measuring the baseline-to-endpoint change in the Montgomery-Asberg Depression Rating Scale (MADRS)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026