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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 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

B.A. Psychiatric Research Cent, Buenos Aires, Argentina

Dr. Gregorio Hugo Sorin, Buenos Aires, Argentina

INECO, Buenos Aires, Argentina

Instituto FLENI, Buenos Aires, Argentina

Sanatorio Prof. León S. Morra SA, Córdoba, Argentina

Centro de Investigación y asistencia en Psiquiatria (CIAP), Rosario, Argentina

District Department of Psychiatric Disorders With Stationary, Bourgas, Bulgaria

State Psychiatric Hospital - Pazardjik, Pazardjik, Bulgaria

Psychiatric clinic for women UMHAT "Dr. Georgi Stranski", Pleven, Bulgaria

ODPZS- EOOD, Plovdiv, Bulgaria, Plovdiv, Bulgaria

MHAT Doverie, Sofia, Bulgaria

Psychiatric clinic, University Hospital "Alexandrovska", Sofia, Bulgaria

Diagnostic Consultative Center "Tchaika", Varna, Bulgaria

MHAT - Sveta Marina, Varna, Bulgaria

CMP/CHS du Jura, Dole, France

Centre Hospitalier de Jonzac, Jonzac, France

Hopital Universitaire Caremeau-Batiment Polyvalent, Service, Nîmes, France

Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy, Bydgoszcz, Poland

Klinika Chorob Psychicznych i Zaburzen Nerwicowych GUM, Gdansk, Poland

Wojewodzki Szpital Psychiatryczny im. prof. Tadeusza Bilikie, Gdansk, Poland

Malopolskie Centrum Medyczne, Krakow, Poland

Cape Trial Centre, Cape Town, South Africa

Flexivest Fourteen Research Centre, Cape Town, South Africa

Knighton Surgery, Cape Town, South Africa

Vista Clinic, Centurion, South Africa

Dr Magnus & Dr Brink, Johannesburg, South Africa

Paarl Medical Centre, Paarl, South Africa

Dey Clinic, Pretoria, South Africa

Hospital del Henares, Coslada (Madrid), Spain

Clínica Universitaria de Navarra, Pamplona, Spain

Hospital Psiquiátrico de Álava, Vitoria-Gasteiz, Spain

Hospital Santiago Apostol, Vitoria, Spain

Donetsk National Medical University n.a. M. Horkyy, Donetsk, Ukraine

Public Institution "Institute of Neurology, Psychiatry and N, Kharkiv, Ukraine

Kiev City Psychoneurological Hospital N 1, CNTRP, Kiev, Ukraine

Danylo Galitsky Lviv State Medical University, Lviv, Ukraine

Odessa Regional Psychoneurology Dispensary, Odessa, Ukraine

Vinnytsa National Medical University named by M.I. Pirogov, Vinnitsa, Ukraine

Birmingham Psychiatry Pharmaceutical Studies, Inc, Birmingham, Alabama, United States

Grey Nuns Hospital, Edmonton, Alberta, Canada

Dr. Alexander McIntyre, Inc., Penticton, British Columbia, Canada

South Coast Medical Associates/SC Clinical Trials, Inc., Anaheim, California, United States

Comprehensive NeuroScience, Cerritos, California, United States

Sun Valley Behavioral Medical, Imperial, California, United States

North County Clinical Research, Oceanside, California, United States

CNRI Los Angeles LLC, Pico Rivera, California, United States

CNRI-San Diego LLC, San Diego, California, United States

Clinical Innovations Inc., Santa Ana, California, United States

Schuster Medical Research Institute, Sherman Oaks, California, United States

Stanford University Medical Center, Stanford, California, United States

Viking Clinical Research Center, Temecula, California, United States

Comprehensive NeuroScience, Washington DC, District of Columbia, United States

Scientific Clinical Research, Inc., Aventura, Florida, United States

Florida Clinical Research Center, Bradenton, Florida, United States

Clinical Neuroscience Solutions Inc, Jacksonville, Florida, United States

Fidelity Clinical Research, Lauderhill, Florida, United States

Compass Research, LLC, Orlando, Florida, United States

Stedman Clinical Trials, LLC, Tampa, Florida, United States

Atlanta Center for Medical Research, Atlanta, Georgia, United States

Carman Research, Smyrna, Georgia, United States

Hawaii Clinical Research Center, Honolulu, Hawaii, United States

Midwest Center for Neurobehavioral Medicine, Oakbrook Terrace, Illinois, United States

CNS - Comprehensive Neuro Science, Park Ridge, Illinois, United States

Community Research, Crestview Hills, Kentucky, United States

AccelRx Research, Fall River, Massachusetts, United States

Mayo College of Medicine, Rochester, Minnesota, United States

Precise Research Centers, Flowood, Mississippi, United States

CRI Worldwide, LLC, Mount Laurel, New Jersey, United States

Behavioral Medical Research of Brooklyn, Brooklyn, New York, United States

Fieve Clinical Services, Inc., New York, New York, United States

Medical and Behavioral Health Research, New York, New York, United States

Behavioral Medical Research of Staten Island, Staten Island, New York, United States

Richmond Behavioral Associates, Staten Island, New York, United States

Odessa Regional Mental Hospital #2, s. Oleksandrivka, Odessa, Ukraine

North Coast Clinical Trials, Inc., Beachwood, Ohio, United States

Neuro-Behavioral Clinical Research, Inc, Canton, Ohio, United States

IPS Research Company, Oklahoma City, Oklahoma, United States

Providence Care Mental Health Services, Kingston, Ontario, Canada

Medical Research Associates, Mississauga, Ontario, Canada

Oregon Center for Clinical Investigators, Inc. (OCCI, Inc.), Portland, Oregon, United States

Lehigh Center for Clinical Research, Allentown, Pennsylvania, United States

Belmont Center for Comprehensive Treatment, Philadelphia, Pennsylvania, United States

Hôpital Louis Hlafontaine, Montreal, Quebec, Canada

FutureSearch Trials of Neurology, Austin, Texas, United States

Insite Clinical Research, Desoto, Texas, United States

Red Oak Psychiatry Associates, P.A., Houston, Texas, United States

University Hills Clinical Research, Irving, Texas, United States

Aspen Clinical Research, LLC, Orem, Utah, United States

Clinical Methods, Salt Lake City, Utah, United States

Neurotherapy Victoria Clinical Trials, Malvern, Victoria, Australia

Northern Area Mental Health Services Northern Psychiatric R, Melbourne, Victoria, Australia

Alliance Research Group, Richmond, Virginia, United States

Additional Information

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

Page last updated: August 23, 2015

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