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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: Armodafinil (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Cephalon

Official(s) and/or principal investigator(s):
Sponsor's Medical Expert, Study Director, Affiliation: Cephalon

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.

Clinical Details

Official title: A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

Secondary outcome:

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

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

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

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

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

Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale

Participants With Treatment-Emergent Adverse Events (TEAE)

Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score

Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score

Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

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

Additional Information

Starting date: January 2010
Last updated: January 15, 2015

Page last updated: August 23, 2015

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