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

NCT00481195 | Completed Phase 2 Results

• 1 other identifier: C10953/2032/DP/US
• Study Type: interventional
• Target: 257
• Locations: 4 countries
• Sites: 55

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

Outcome Measures

Primary Outcomes (1)

• The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

  The IDS C30 is a standardized 30 item, clinician rated scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Endpoint (either week 8 or the last observation after baseline) in the total score of the IDS-C30.

  Baseline and 8 weeks from start of study drug administration (or last observation after baseline)

Secondary Outcomes (39)

• The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

  Baseline and 1 week following the start of study drug administration

• The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

  Baseline and 2 weeks following the start of study drug administration

• The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

  Baseline and 3 weeks following the start of study drug administration

• The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

  Baseline and 4 weeks following the start of study drug administration

• The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

  Baseline and 6 weeks following the start of study drug administration

Study Arms (2)

Armodafinil

ACTIVE COMPARATOR

Drug: Armodafinil

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Armodafinil 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.

Armodafinil

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Cephalon: lead

Study Sites (55)

Birmingham Research Group

Birmingham, Alabama, 35216, United States

Location

Birmingham Psychiatry Pharmaceutical Studies, Inc

Birmingham, Alabama, 35226, United States

Location

Synergy Clinical Research Center

Escondido, California, 92025, United States

Location

Bay Area Research Institute

Lafayette, California, 94549, United States

Location

Synergy Clinical Research Center

National City, California, 91950, United States

Location

Excell Research

Oceanside, California, 92056, United States

Location

Pacific Clinical Research Medical Group

Orange, California, 92868, United States

Location

CNRI Los Angeles LLC

Pico Rivera, California, 90660, United States

Location

Pacific Clinical Research Medical Group

Riverside, California, 92506, United States

Location

California Neuropsychopharmacology Clinical Research Inst

San Diego, California, 92126, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Clinical Neuroscience Solutions Inc

Jacksonville, Florida, 32216, United States

Location

Fidelity Clinical Research

Lauderhill, Florida, 33319, United States

Location

Stedman Clinical Trials, LLC

Tampa, Florida, 33613, United States

Location

Janus Center for Psychiatric Research

West Palm Beach, Florida, 33407, United States

Location

Atlanta Center for Clinical Research

Atlanta, Georgia, 30308, United States

Location

Carman Research

Smyrna, Georgia, 30080, United States

Location

Psychiatric Medicine Associates

Skokie, Illinois, 60076, United States

Location

Capital Clinical Research Associates

Rockville, Maryland, 20852, United States

Location

CNS Research Institute

Clementon, New Jersey, 08021, United States

Location

Behavioral Medical Research of Brooklyn

Brooklyn, New York, 11201, United States

Location

Social Psychiatry Research Institute

Brooklyn, New York, 11235, United States

Location

Social Psychiatry Research Institute

New York, New York, 10021, United States

Location

Medical & Behavioral Health Research

New York, New York, 10023, United States

Location

Behavioral Medical Research of Staten Island

Staten Island, New York, 10305, United States

Location

Richard Weisler, MD and Associates

Raleigh, North Carolina, 27609, United States

Location

Piedmont Clinical Trials, Inc.

Winston-Salem, North Carolina, 27104, United States

Location

Mood Disorders Program

Cleveland, Ohio, 44106, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45408, United States

Location

Sooner Clinical Research

Oklahoma City, Oklahoma, 73112, United States

Location

Oregon Center for Clinical Investigations, Inc.

Salem, Oregon, 97301, United States

Location

Dubois Regional Medical Center - Behavioral Health Services

DuBois, Pennsylvania, 15801, United States

Location

Keystone Clinical Studies LLC

Norristown, Pennsylvania, 19401, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

CRI Worldwide

Philadelphia, Pennsylvania, 19139, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

Community Clinical Research

Austin, Texas, 78754, United States

Location

Claghorn-Lesem Research Clinic, LTD

Bellaire, Texas, 77401, United States

Location

University Hills Clinical Research

Irving, Texas, 75062, United States

Location

Grayline Clinical Drug Trials

Wichita Falls, Texas, 76309, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

Location

Eastside Therapeutic Resource

Kirkland, Washington, 98033, United States

Location

Call For Information

Burgas, 8000, Bulgaria

Location

Call For Information - Center Site #2

Plovdiv, 4002, Bulgaria

Location

Call For Information

Plovdiv, 4002, Bulgaria

Location

Call For Information - Center Site #2

Sofia, 1113, Bulgaria

Location

Call For Information

Sofia, 1113, Bulgaria

Location

Call For Information

Budapest, H-1135, Hungary

Location

Call For Information

Nagykálló, H-4321, Hungary

Location

Call For Information

Bucharest, 010604, Romania

Location

Call For Information

Bucharest, 030455, Romania

Location

Call For Information - Center Site #2

Bucharest, 041915, Romania

Location

Call For Information

Bucharest, 041915, Romania

Location

Call For Information

Piteşti, 110069, Romania

Location

Call For Information

Târgovişte, 190081, Romania

Location

Related Publications (1)

• 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.

  PMID: 20673554 DERIVED

MeSH Terms

Interventions

Modafinil

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Medical Monitor
• Organization: Cephalon, Inc.

1-800-896-5855

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2007
• First Posted: June 1, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 19, 2013
• Results First Posted: December 20, 2010

Record last verified: 2013-07

Locations

HU (2); US (42); BU (5); RO (6)