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

NCT ID: NCT01072929

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 433 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-03-31

Brief Summary

The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Armodafinil 150 mg/day

Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.

Group Type: EXPERIMENTAL

Armodafinil

Intervention Type: DRUG

Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning.

Armodafinil 200 mg/day

Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.

Group Type: EXPERIMENTAL

Armodafinil

Intervention Type: DRUG

Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning.

Placebo

Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo, also in tablet form taken orally, once daily in the morning.

Interventions

Armodafinil

Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning.

Intervention Type: DRUG

Placebo

Matching Placebo, also in tablet form taken orally, once daily in the morning.

Intervention Type: DRUG

Other Intervention Names

Nuvigil; CEP-10953

Eligibility Criteria

Inclusion Criteria

• The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria and is currently experiencing a major depressive episode.
• Documentation that the patient has had at least 1 previous manic or mixed episode.
• The patient has had no more than 6 mood episodes in the last year.
• The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began.
• The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, risperidone, or ziprasidone (only if taken in combination with lithium or valproic acid).
• Written informed consent is obtained.
• The patient is a man or woman 18 through 65 years of age.
• The patient is in good health (except for diagnosis of bipolar I disorder) as judged by the investigator, on the basis of medical and psychiatric history, medical examination, electrocardiography (ECG), serum chemistry, hematology, and urinalysis.
• Women of childbearing potential (women who have not reached menopause, women who are less than 2 years postmenopausal, and women who are not surgically sterile) who are sexually active must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
• The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.
• The patient has permanent accommodations and means of being contacted by the study center.
• The patient understands that they may enroll in this clinical study only once and may not enroll in any other clinical study while participating in this trial.

Exclusion Criteria

• The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period.
• The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period.
• 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 has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period.
• The patient has a history of alcohol or substance abuse or dependence (with the exception of nicotine dependence) within 3 months of the screening visit or during the screening period.
• The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or a history of multiple clinically relevant allergies.
• The patient has any clinically significant uncontrolled medical condition, treated or untreated.
• The patient has received modafinil or armodafinil within the past 5 years, or the patient has a known sensitivity to any ingredients in the study drug tablets.
• The patient has previously participated in a clinical study with armodafinil or has used any investigational product within 90 days of screening. The patient may not enroll in any other clinical study while participating in this study.
• The patient has ever been treated with vagus nerve stimulation (VNS) or deep brain stimulation (DBS), or has been treated with electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) within 3 months of the screening visit.
• The patient is a pregnant or lactating woman.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cephalon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sponsor's Medical Expert

Role: STUDY_DIRECTOR

Cephalon

Locations

Birmingham Research Group

Birmingham, Alabama, United States

Southwestern Research

Beverly Hills, California, United States

Collaborative NeuroScience Network

Garden Grove, California, United States

Sun Valley Behavioral Medical

Imperial, California, United States

University of California Irvine

Irvine, California, United States

Excell Research

Oceanside, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Clinical Innovations Inc.

Santa Ana, California, United States

Viking Clinical Research Center

Temecula, California, United States

CNS Clinical Research Group - Florida Clinical Research Cent

Coral Springs, Florida, United States

Gulfcoast Clinical Research Center

Fort Myers, Florida, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Dr. Vijapura and Assoc.

Jacksonville, Florida, United States

Fidelity Clinical Research

Lauderhill, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

University of South Florida

Tampa, Florida, United States

Comprehensive Neuroscience, Inc

Atlanta, Georgia, United States

Northwest Behavioral Research Center

Roswell, Georgia, United States

AMR Baber Research Inc.

Naperville, Illinois, United States

American Medical Research

Oak Brook, Illinois, United States

CNS - Comprehensive Neuro Science

Park Ridge, Illinois, United States

Pharmasite Research, Inc

Baltimore, Maryland, United States

AccelRx Research

Fall River, Massachusetts, United States

Mid-America Clinical Research, LLC

St Louis, Missouri, United States

CRI Worldwide, LLC

Mount Laurel, New Jersey, United States

Albequerque Neuroscience

Albuquerque, New Mexico, United States

Social Psychiatry Research Institute

Brooklyn, New York, United States

Eastside Comprehensive Medical Center

New York, New York, United States

Finger Lakes Clinical Research

Rochester, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Richard Weisler, MD and Associates

Raleigh, North Carolina, United States

Charak Clinical Research Center

Beachwood, Ohio, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

Oregon Center for Clinical Investigations, Inc

Salem, Oregon, United States

Suburban Research Associates

Media, Pennsylvania, United States

Scranton Counseling Center

Scranton, Pennsylvania, United States

Carolina Clinical Trials, Inc.

Charleston, South Carolina, United States

Community Clinical Research

Austin, Texas, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Countries

United States

References

Calabrese JR, Frye MA, Yang R, Ketter TA; Armodafinil Treatment Trial Study Network. Efficacy and safety of adjunctive armodafinil in adults with major depressive episodes associated with bipolar I disorder: a randomized, double-blind, placebo-controlled, multicenter trial. J Clin Psychiatry. 2014 Oct;75(10):1054-61. doi: 10.4088/JCP.13m08951.

Reference Type: RESULT

PMID: 25099397 (View on PubMed)

Other Identifiers

2009-016667-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C10953/3071

Identifier Type: -

Identifier Source: org_study_id