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

NCT01072929 | Completed Phase 3 Results DMC

• 2 other identifiers: C10953/30712009-016667-11
• Study Type: interventional
• Target: 433
• Locations: 1 country
• Sites: 40

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

Keywords

Bipolar I Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 8 in the Total Score From 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 participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.

  Day 0 (baseline), Week 8

Secondary Outcomes (22)

• Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

  Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

• Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

  Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

• Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

  Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

• Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)

  Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

• Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression

  Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Study Arms (3)

Armodafinil 150 mg/day

EXPERIMENTAL

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.

Drug: Armodafinil

Armodafinil 200 mg/day

EXPERIMENTAL

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.

Drug: Armodafinil

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Armodafinil DRUG

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

Also known as: Nuvigil, CEP-10953

Armodafinil 150 mg/day; Armodafinil 200 mg/day

Placebo DRUG

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

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 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.

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 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.

Sponsors & Collaborators

• Cephalon: lead

Study Sites (40)

Birmingham Research Group

Birmingham, Alabama, United States

Location

Southwestern Research

Beverly Hills, California, United States

Location

Collaborative NeuroScience Network

Garden Grove, California, United States

Location

Sun Valley Behavioral Medical

Imperial, California, United States

Location

University of California Irvine

Irvine, California, United States

Location

Excell Research

Oceanside, California, United States

Location

Artemis Institute for Clinical Research

San Diego, California, United States

Location

Clinical Innovations Inc.

Santa Ana, California, United States

Location

Viking Clinical Research Center

Temecula, California, United States

Location

CNS Clinical Research Group - Florida Clinical Research Cent

Coral Springs, Florida, United States

Location

Gulfcoast Clinical Research Center

Fort Myers, Florida, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, United States

Location

Dr. Vijapura and Assoc.

Jacksonville, Florida, United States

Location

Fidelity Clinical Research

Lauderhill, Florida, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Location

University of South Florida

Tampa, Florida, United States

Location

Comprehensive Neuroscience, Inc

Atlanta, Georgia, United States

Location

Northwest Behavioral Research Center

Roswell, Georgia, United States

Location

AMR Baber Research Inc.

Naperville, Illinois, United States

Location

American Medical Research

Oak Brook, Illinois, United States

Location

CNS - Comprehensive Neuro Science

Park Ridge, Illinois, United States

Location

Pharmasite Research, Inc

Baltimore, Maryland, United States

Location

AccelRx Research

Fall River, Massachusetts, United States

Location

Mid-America Clinical Research, LLC

St Louis, Missouri, United States

Location

CRI Worldwide, LLC

Mount Laurel, New Jersey, United States

Location

Albequerque Neuroscience

Albuquerque, New Mexico, United States

Location

Social Psychiatry Research Institute

Brooklyn, New York, United States

Location

Eastside Comprehensive Medical Center

New York, New York, United States

Location

Finger Lakes Clinical Research

Rochester, New York, United States

Location

Richmond Behavioral Associates

Staten Island, New York, United States

Location

Richard Weisler, MD and Associates

Raleigh, North Carolina, United States

Location

Charak Clinical Research Center

Beachwood, Ohio, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, United States

Location

Oregon Center for Clinical Investigations, Inc

Salem, Oregon, United States

Location

Suburban Research Associates

Media, Pennsylvania, United States

Location

Scranton Counseling Center

Scranton, Pennsylvania, United States

Location

Carolina Clinical Trials, Inc.

Charleston, South Carolina, United States

Location

Community Clinical Research

Austin, Texas, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, United States

Location

Related Publications (1)

• 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.

  PMID: 25099397 RESULT

MeSH Terms

Conditions

Depression

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Sponsor's Medical Expert

  Cephalon

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 22, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 27, 2016
• Results First Posted: January 26, 2015

Record last verified: 2016-04

Locations

US (40)