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TERMINATEDPHASE3

Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

Adjunctive Lisdexamfetamine in Bipolar Depression

NCT01093963•Lindner Center of HOPE

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.

Eligibility

Age

18 - 55 years

Sex

ALL

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.

Locations (1)

Lindner Center of HOP

Mason, Ohio, United States

Key Dates

Start Date

January 1, 2010

Primary Completion Date

February 1, 2014

Completion Date

February 1, 2014

Last Updated

September 2, 2015

Enrollment

ACTUAL participants

Conditions

Bipolar Depression

Interventions

Lisdexamfetamine

DRUG

Placebo

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 2, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure

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Delivering Electronic Cognitive Behavioural Therapy to Patients With Bipolar Disorder and Residual Depressive Symptoms