A Preliminary Study of the Effectiveness and Tolerability of Aripiprazole in Bipolar Depression

Lindner Center of HOPE1 site in 1 country31 target enrollmentAugust 2006

ConditionsBipolar Depression

Drugsaripiprazole

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Bipolar Depression
Sponsor: Lindner Center of HOPE
Enrollment: 31
Locations: 1
Primary Endpoint: Montgomery-Asberg Depression Rating Scale (MADRS)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The specific aim of this study is to obtain preliminary evidence of the acute effectiveness and tolerability of aripiprazole in the treatment of bipolar depression.

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

March 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Lindner Center of HOPE

Eligibility Criteria

Inclusion Criteria

•subjects must have bipolar I, II or NOS disorder as defined by DSM-IV-TR; must have clinical significant depressive symptoms and have failed one or more mood stabilizer trials; may or may not be receiving antimanic or mood stabilizing medications; subjects or legally authorized representative must sign the Informed Consent document after the nature of the trial has been fully explained; if female, subjects must be postmenopausal, surgically incapable of childbearing or practicing medically acceptable effective method(s) of contraception.

Exclusion Criteria

•subjects who do not have bipolar disorder by DSM-IV criteria; subjects with current DSM-IV Axis I diagnosis of delirium, dementia, amnesia or other cognitive disorders or a psychotic disorder; subjects with serious general medical illness; subjects who are allergic to or have demonstrated hypersensitivity to aripiprazole; women who are pregnant or nursing; subjects who have received an experimental drug or used an experimental device within 30 days; subjects who have a history of neurologic malignant syndrome.