An 8 Week Study to Evaluate Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder - Full Text View

Sponsor:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00481195

Purpose

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.

Condition	Intervention	Phase
Bipolar I Depression	Drug: Armodafinil	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An 8 Week Double Blind, Placebo-Controlled, Parallel Group, Fixed Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Armodafinil

U.S. FDA Resources

Further study details as provided by Cephalon:

Primary Outcome Measures:

Determine if armodafinil treatment is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder, as assessed by the IDS-C30. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MADRS, QIDS-SR16, Q-LES-Q-SF, HAM-A, CGI-BP [ Time Frame: 8 weeks, and at Intermediate Points ] [ Designated as safety issue: No ]
YMRS [ Time Frame: 8 weeks, and at Intermediate Points ] [ Designated as safety issue: Yes ]

Enrollment:	264
Study Start Date:	May 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Armodafinil Patients will begin oral treatment with armodafinil or placebo, which will be titrated to 150 mg/day (3 tablets) of the randomly assigned study drug (armodafinil or placebo).

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key 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.

Key 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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481195

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Locations

United States, Alabama
Birmingham Research Group
Birmingham, Alabama, United States, 35216
Birmingham Psychiatry Pharmaceutical Studies, Inc
Birmingham, Alabama, United States, 35226
United States, California
Synergy Clinical Research Center
National City, California, United States, 91950
Pacific Clinical Research Medical Group
Orange, California, United States, 92868
Excell Research
Oceanside, California, United States, 92056
Pacific Clinical Research Medical Group
Riverside, California, United States, 92506
Stanford University
Stanford, California, United States, 94305
Bay Area Research Institute
Lafayette, California, United States, 94549
CNRI Los Angeles LLC
Pico Rivera, California, United States, 90660
California Neuropsychopharmacology Clinical Research Inst
San Diego, California, United States, 92126
Synergy Clinical Research Center
Escondido, California, United States, 92025
United States, Florida
Stedman Clinical Trials, LLC
Tampa, Florida, United States, 33613
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States, 33407
Fidelity Clinical Research
Lauderhill, Florida, United States, 33319
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, United States, 32216
United States, Georgia
Carman Research
Smyrna, Georgia, United States, 30080
Atlanta Center for Clinical Research
Atlanta, Georgia, United States, 30308
United States, Illinois
Psychiatric Medicine Associates
Skokie, Illinois, United States, 60076
United States, Maryland
Capital Clinical Research Associates
Rockville, Maryland, United States, 20852
United States, New Jersey
CNS Research Institute
Clementon, New Jersey, United States, 08021
United States, New York
Behavioral Medical Research of Staten Island
Staten Island, New York, United States, 10305
Social Psychiatry Research Institute
New York, New York, United States, 10021
Social Psychiatry Research Institute
Brooklyn, New York, United States, 11235
Medical & Behavioral Health Research
New York, New York, United States, 10023
Behavioral Medical Research of Brooklyn
Brooklyn, New York, United States, 11201
United States, North Carolina
Richard Weisler, MD and Associates
Raleigh, North Carolina, United States, 27609
Piedmont Clinical Trials, Inc.
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Midwest Clinical Research Center
Dayton, Ohio, United States, 45408
Mood Disorders Program
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Sooner Clinical Research
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, United States, 97301
United States, Pennsylvania
Dubois Regional Medical Center - Behavioral Health Services
Dubois, Pennsylvania, United States, 15801
Keystone Clinical Studies LLC
Norristown, Pennsylvania, United States, 19401
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
CRI Worldwide
Philadelphia, Pennsylvania, United States, 19139
United States, Tennessee
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States, 38119
United States, Texas
Claghorn-Lesem Research Clinic, LTD
Bellaire, Texas, United States, 77401
University Hills Clinical Research
Irving, Texas, United States, 75062
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States, 76309
Community Clinical Research
Austin, Texas, United States, 78754
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98004
Eastside Therapeutic Resource
Kirkland, Washington, United States, 98033
Bulgaria
Call For Information
Burgas, Bulgaria, 8000
Call For Information
Plovdiv, Bulgaria, 4002
Call For Information - Center Site #2
Plovdiv, Bulgaria, 4002
Call For Information
Sofia, Bulgaria, 1113
Call For Information - Center Site #2
Sofia, Bulgaria, 1113
Hungary
Call For Information
Budapest, Hungary, H-1135
Call For Information
Nagykálló, Hungary, H-4321
Romania
Call For Information
Bucuresti, Romania, 030455
Call For Information
Bucuresti, Romania, 010604
Call For Information
Bucuresti, Romania, 041915
Call For Information
Pitesti, Romania, 110069
Call For Information
Targoviste, Romania, 190081
Call For Information - Center Site #2
Bucuresti, Romania, 041915

Sponsors and Collaborators

Cephalon

More Information

No publications provided

Responsible Party:	Cephalon ( Sponsor's Medical Expert )
Study ID Numbers:	C10953/2032/DP/US
Study First Received:	May 30, 2007
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00481195 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Depression
Physiological Effects of Drugs
Central Nervous System Stimulants
Depressive Disorder, Major
Depressive Disorder
Protective Agents
Neuroprotective Agents

Modafinil
Pharmacologic Actions
Behavioral Symptoms
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2009