Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

NCT ID: NCT00481195

Last Updated: 2013-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 257 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-12-31

Brief Summary

The primary objective of the study is to determine if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to their current treatment for a current major depressive episode.

Conditions

Bipolar I Depression

Study Design

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

Study Groups

Armodafinil

Group Type: ACTIVE_COMPARATOR

Armodafinil

Intervention Type: DRUG

Patients were randomly assigned to begin oral treatment with armodafinil, which was titrated to 150 mg/day (3 tablets). Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day \[2 tablets\]) was allowed. The dosage could not be increased after it was decreased.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients were randomly assigned to begin oral treatment with placebo, which was titrated to 3 tablets. Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.

Interventions

Armodafinil

Patients were randomly assigned to begin oral treatment with armodafinil, which was titrated to 150 mg/day (3 tablets). Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day \[2 tablets\]) was allowed. The dosage could not be increased after it was decreased.

Intervention Type: DRUG

Placebo

Patients were randomly assigned to begin oral treatment with placebo, which was titrated to 3 tablets. Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The patient has a diagnosis of Bipolar I Disorder and is currently experiencing a major depressive episode.
• The patient is currently being treated with 1 or 2 of the following drugs: lithium, olanzapine, or valproic acid.

Exclusion Criteria

• The patient has any Axis I disorder apart from Bipolar I Disorder that was the primary focus of treatment within 6 months before the screening visit (with the exception of nicotine dependence).
• The patient has any clinically significant uncontrolled medical or surgical condition.
• The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
• The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)

• 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

Locations

Birmingham Research Group

Birmingham, Alabama, United States

Birmingham Psychiatry Pharmaceutical Studies, Inc

Birmingham, Alabama, United States

Synergy Clinical Research Center

Escondido, California, United States

Bay Area Research Institute

Lafayette, California, United States

Synergy Clinical Research Center

National City, California, United States

Excell Research

Oceanside, California, United States

Pacific Clinical Research Medical Group

Orange, California, United States

CNRI Los Angeles LLC

Pico Rivera, California, United States

Pacific Clinical Research Medical Group

Riverside, California, United States

California Neuropsychopharmacology Clinical Research Inst

San Diego, California, United States

Stanford University

Stanford, California, United States

Clinical Neuroscience Solutions Inc

Jacksonville, Florida, United States

Fidelity Clinical Research

Lauderhill, Florida, United States

Stedman Clinical Trials, LLC

Tampa, Florida, United States

Janus Center for Psychiatric Research

West Palm Beach, Florida, United States

Atlanta Center for Clinical Research

Atlanta, Georgia, United States

Carman Research

Smyrna, Georgia, United States

Psychiatric Medicine Associates

Skokie, Illinois, United States

Capital Clinical Research Associates

Rockville, Maryland, United States

CNS Research Institute

Clementon, New Jersey, United States

Behavioral Medical Research of Brooklyn

Brooklyn, New York, United States

Social Psychiatry Research Institute

Brooklyn, New York, United States

Social Psychiatry Research Institute

New York, New York, United States

Medical & Behavioral Health Research

New York, New York, United States

Behavioral Medical Research of Staten Island

Staten Island, New York, United States

Richard Weisler, MD and Associates

Raleigh, North Carolina, United States

Piedmont Clinical Trials, Inc.

Winston-Salem, North Carolina, United States

Mood Disorders Program

Cleveland, Ohio, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

Sooner Clinical Research

Oklahoma City, Oklahoma, United States

Oregon Center for Clinical Investigations, Inc.

Salem, Oregon, United States

Dubois Regional Medical Center - Behavioral Health Services

DuBois, Pennsylvania, United States

Keystone Clinical Studies LLC

Norristown, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

CRI Worldwide

Philadelphia, Pennsylvania, United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Community Clinical Research

Austin, Texas, United States

Claghorn-Lesem Research Clinic, LTD

Bellaire, Texas, United States

University Hills Clinical Research

Irving, Texas, United States

Grayline Clinical Drug Trials

Wichita Falls, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Eastside Therapeutic Resource

Kirkland, Washington, United States

Call For Information

Burgas, , Bulgaria

Call For Information - Center Site #2

Plovdiv, , Bulgaria

Call For Information

Plovdiv, , Bulgaria

Call For Information - Center Site #2

Sofia, , Bulgaria

Call For Information

Sofia, , Bulgaria

Call For Information

Budapest, , Hungary

Call For Information

Nagykálló, , Hungary

Call For Information

Bucharest, , Romania

Call For Information

Bucharest, , Romania

Call For Information - Center Site #2

Bucharest, , Romania

Call For Information

Bucharest, , Romania

Call For Information

Piteşti, , Romania

Call For Information

Târgovişte, , Romania

Countries

United States; Bulgaria; Hungary; Romania

References

Calabrese JR, Ketter TA, Youakim JM, Tiller JM, Yang R, Frye MA. Adjunctive armodafinil for major depressive episodes associated with bipolar I disorder: a randomized, multicenter, double-blind, placebo-controlled, proof-of-concept study. J Clin Psychiatry. 2010 Oct;71(10):1363-70. doi: 10.4088/JCP.09m05900gry. Epub 2010 Jul 27.

Reference Type: DERIVED

PMID: 20673554 (View on PubMed)

Other Identifiers

C10953/2032/DP/US

Identifier Type: -

Identifier Source: org_study_id

NCT00547222

Identifier Type: -

Identifier Source: nct_alias