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Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

NCT01121536•Cephalon

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The patient has completed 8 weeks of treatment in a Cephalon-sponsored Phase 3, double-blind study of armodafinil treatment in patients with major depression associated with bipolar I disorder.
•The patient met criteria for enrollment in the previous double-blind study and, in the opinion of the investigator, is in need of continued treatment for depression.
•During the previous double-blind study, the patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium; valproic acid; olanzapine; quetiapine; aripiprazole; lamotrigine; risperidone; ziprasidone, (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:
•1. The mood stabilizers must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation.
•2. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.
•3. The patient must be judged by the investigator to be compliant with treatment with the mood stabilizer(s).
•4. The patient must be willing to continue treatment with the same protocol-allowed mood stabilizer(s) at dosages considered appropriate by the investigator.
•The patient has a Young Mania Rating Scale (YMRS) total score of 14 or less at the enrollment visit. Patients who have a YMRS score of 12 through 14 must be discussed with the medical monitor to determine their suitability for enrollment.

Exclusion Criteria

•The patient has any Axis I or Axis II disorder apart from bipolar I disorder that became the primary focus of treatment during the double-blind study.
•The patient has psychotic symptoms or had psychosis during the double-blind study.
•The patient has current active suicidal ideation, is at imminent risk of self harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
•The patient met criteria for alcohol or substance abuse or dependence (with the exception of nicotine dependence) during the double-blind study.
•The patient has any history of homicidal ideation or significant aggression or currently has homicidal or significant aggressive ideation.

Locations (158)

Teva Investigational Site 113

Birmingham, Alabama, United States

Teva Investigational Site 225

Birmingham, Alabama, United States

Teva Investigational Site 229

Anaheim, California, United States

Teva Investigational Site 217

Cerritos, California, United States

Teva Investigational Site 223

Cerritos, California, United States

Teva Investigational Site 115

Garden Grove, California, United States

Teva Investigational Site 121

Imperial, California, United States

Teva Investigational Site 303

Oceanside, California, United States

Teva Investigational Site 400

Oceanside, California, United States

Teva Investigational Site 200

Pico Rivera, California, United States

Key Dates

Start Date

April 30, 2010

Primary Completion Date

October 31, 2013

Completion Date

October 31, 2013

Last Updated

September 21, 2018

Enrollment

867

ACTUAL participants

Conditions

Depression

Interventions

Armodafinil

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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 21, 2018Data 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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Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Inclusion Criteria

Exclusion Criteria

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