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

NCT ID: NCT01072630

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 492 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Armodafinil 150 mg/day

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.

Group Type: EXPERIMENTAL

Armodafinil

Intervention Type: DRUG

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

Armodafinil 200 mg/day

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.

Group Type: EXPERIMENTAL

Armodafinil

Intervention Type: DRUG

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

Interventions

Armodafinil

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Nuvigil; CEP-10953

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cephalon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sponsor's Medical Expert

Role: STUDY_DIRECTOR

Cephalon

Locations

Birmingham Psychiatry Pharmaceutical Studies, Inc

Birmingham, Alabama, United States

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 D.C., 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

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

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

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

Alliance Research Group

Richmond, Virginia, United States

Dr. Gregorio Hugo Sorin

Buenos Aires, Buenos Aires, Argentina

INECO

Buenos Aires, Buenos Aires, Argentina

Instituto FLENI

Buenos Aires, Buenos Aires, Argentina

Sanatorio Prof. León S. Morra SA

Córdoba, Córdoba Province, Argentina

Centro de Investigación y asistencia en Psiquiatria (CIAP)

Rosario, Rosario, Argentina

B.A. Psychiatric Research Cent

Buenos Aires, , Argentina

Neurotherapy Victoria Clinical Trials

Malvern, Victoria, Australia

Northern Area Mental Health Services Northern Psychiatric R

Melbourne, Victoria, Australia

MHAT Doverie

Sofia, Sofia, Bulgaria

Psychiatric clinic, University Hospital "Alexandrovska"

Sofia, Sofia, Bulgaria

MHAT - Sveta Marina

Varna, Varna, Bulgaria

District Department of Psychiatric Disorders With Stationary

Burgas, , Bulgaria

State Psychiatric Hospital - Pazardjik

Pazardzhik, , Bulgaria

Psychiatric clinic for women UMHAT "Dr. Georgi Stranski"

Pleven, , Bulgaria

ODPZS- EOOD, Plovdiv, Bulgaria

Plovdiv, , Bulgaria

Diagnostic Consultative Center "Tchaika"

Varna, , Bulgaria

Grey Nuns Hospital

Edmonton, Alberta, Canada

Dr. Alexander McIntyre, Inc.

Penticton, British Columbia, Canada

Providence Care Mental Health Services

Kingston, Ontario, Canada

Medical Research Associates

Mississauga, Ontario, Canada

Hôpital Louis Hlafontaine

Montreal, Quebec, Canada

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, 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-Gasteiz, , Spain

Danylo Galitsky Lviv State Medical University

Lviv, Lviv Oblast, Ukraine

Odessa Regional Mental Hospital #2

S. Oleksandrivka, Odesa Oblast, Ukraine

Vinnytsa National Medical University named by M.I. Pirogov

Vinnitsa, Vinnitsa, Ukraine

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

Odessa Regional Psychoneurology Dispensary

Odesa, , Ukraine

Countries

United States; Argentina; Australia; Bulgaria; Canada; France; Poland; South Africa; Spain; Ukraine

References

Ketter TA, Yang R, Frye MA. Adjunctive armodafinil for major depressive episodes associated with bipolar I disorder. J Affect Disord. 2015 Aug 1;181:87-91. doi: 10.1016/j.jad.2015.04.012. Epub 2015 Apr 15.

Reference Type: DERIVED

PMID: 25933099 (View on PubMed)

Other Identifiers

2009-016634-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C10953/3072

Identifier Type: -

Identifier Source: org_study_id