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

NCT01072630 | Completed Phase 3 Results DMC

• 2 other identifiers: C10953/30722009-016634-27
• Study Type: interventional
• Target: 492
• Locations: 10 countries
• Sites: 92

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)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

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

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 (92)

Birmingham Psychiatry Pharmaceutical Studies, Inc

Birmingham, Alabama, United States

Location

South Coast Medical Associates/SC Clinical Trials, Inc.

Anaheim, California, United States

Location

Comprehensive NeuroScience

Cerritos, California, United States

Location

Sun Valley Behavioral Medical

Imperial, California, United States

Location

North County Clinical Research

Oceanside, California, United States

Location

CNRI Los Angeles LLC

Pico Rivera, California, United States

Location

CNRI-San Diego LLC

San Diego, California, United States

Location

Clinical Innovations Inc.

Santa Ana, California, United States

Location

Schuster Medical Research Institute

Sherman Oaks, California, United States

Location

Stanford University Medical Center

Stanford, California, United States

Location

Viking Clinical Research Center

Temecula, California, United States

Location

Comprehensive NeuroScience

Washington D.C., District of Columbia, United States

Location

Scientific Clinical Research, Inc.

Aventura, Florida, United States

Location

Florida Clinical Research Center

Bradenton, Florida, United States

Location

Clinical Neuroscience Solutions Inc

Jacksonville, Florida, United States

Location

Fidelity Clinical Research

Lauderhill, Florida, United States

Location

Compass Research, LLC

Orlando, Florida, United States

Location

Stedman Clinical Trials, LLC

Tampa, Florida, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Location

Carman Research

Smyrna, Georgia, United States

Location

Hawaii Clinical Research Center

Honolulu, Hawaii, United States

Location

Midwest Center for Neurobehavioral Medicine

Oakbrook Terrace, Illinois, United States

Location

CNS - Comprehensive Neuro Science

Park Ridge, Illinois, United States

Location

Community Research

Crestview Hills, Kentucky, United States

Location

AccelRx Research

Fall River, Massachusetts, United States

Location

Mayo College of Medicine

Rochester, Minnesota, United States

Location

Precise Research Centers

Flowood, Mississippi, United States

Location

CRI Worldwide, LLC

Mount Laurel, New Jersey, United States

Location

Behavioral Medical Research of Brooklyn

Brooklyn, New York, United States

Location

Fieve Clinical Services, Inc.

New York, New York, United States

Location

Medical and Behavioral Health Research

New York, New York, United States

Location

Behavioral Medical Research of Staten Island

Staten Island, New York, United States

Location

Richmond Behavioral Associates

Staten Island, New York, United States

Location

North Coast Clinical Trials, Inc.

Beachwood, Ohio, United States

Location

Neuro-Behavioral Clinical Research, Inc

Canton, Ohio, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, United States

Location

Oregon Center for Clinical Investigators, Inc. (OCCI, Inc.)

Portland, Oregon, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, United States

Location

Belmont Center for Comprehensive Treatment

Philadelphia, Pennsylvania, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, United States

Location

Insite Clinical Research

DeSoto, Texas, United States

Location

Red Oak Psychiatry Associates, P.A.

Houston, Texas, United States

Location

University Hills Clinical Research

Irving, Texas, United States

Location

Aspen Clinical Research, LLC

Orem, Utah, United States

Location

Clinical Methods

Salt Lake City, Utah, United States

Location

Alliance Research Group

Richmond, Virginia, United States

Location

Dr. Gregorio Hugo Sorin

Buenos Aires, Buenos Aires, Argentina

Location

INECO

Buenos Aires, Buenos Aires, Argentina

Location

Instituto FLENI

Buenos Aires, Buenos Aires, Argentina

Location

Sanatorio Prof. León S. Morra SA

Córdoba, Córdoba Province, Argentina

Location

Centro de Investigación y asistencia en Psiquiatria (CIAP)

Rosario, Rosario, Argentina

Location

B.A. Psychiatric Research Cent

Buenos Aires, Argentina

Location

Neurotherapy Victoria Clinical Trials

Malvern, Victoria, Australia

Location

Northern Area Mental Health Services Northern Psychiatric R

Melbourne, Victoria, Australia

Location

MHAT Doverie

Sofia, Sofia, Bulgaria

Location

Psychiatric clinic, University Hospital "Alexandrovska"

Sofia, Sofia, Bulgaria

Location

MHAT - Sveta Marina

Varna, Varna, Bulgaria

Location

District Department of Psychiatric Disorders With Stationary

Burgas, Bulgaria

Location

State Psychiatric Hospital - Pazardjik

Pazardzhik, Bulgaria

Location

Psychiatric clinic for women UMHAT "Dr. Georgi Stranski"

Pleven, Bulgaria

Location

ODPZS- EOOD, Plovdiv, Bulgaria

Plovdiv, Bulgaria

Location

Diagnostic Consultative Center "Tchaika"

Varna, Bulgaria

Location

Grey Nuns Hospital

Edmonton, Alberta, Canada

Location

Dr. Alexander McIntyre, Inc.

Penticton, British Columbia, Canada

Location

Providence Care Mental Health Services

Kingston, Ontario, Canada

Location

Medical Research Associates

Mississauga, Ontario, Canada

Location

Hôpital Louis Hlafontaine

Montreal, Quebec, Canada

Location

CMP/CHS du Jura

Dole, France

Location

Centre Hospitalier de Jonzac

Jonzac, France

Location

Hopital Universitaire Caremeau-Batiment Polyvalent, Service

Nîmes, France

Location

Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy

Bydgoszcz, Bydgoszcz, Poland

Location

Klinika Chorob Psychicznych i Zaburzen Nerwicowych GUM

Gdansk, Poland

Location

Wojewodzki Szpital Psychiatryczny im. prof. Tadeusza Bilikie

Gdansk, Poland

Location

Malopolskie Centrum Medyczne

Krakow, Poland

Location

Cape Trial Centre

Cape Town, South Africa

Location

Flexivest Fourteen Research Centre

Cape Town, South Africa

Location

Knighton Surgery

Cape Town, South Africa

Location

Vista Clinic

Centurion, South Africa

Location

Dr Magnus & Dr Brink

Johannesburg, South Africa

Location

Paarl Medical Centre

Paarl, South Africa

Location

Dey Clinic

Pretoria, South Africa

Location

Hospital del Henares

Coslada (Madrid), Spain

Location

Clínica Universitaria de Navarra

Pamplona, Spain

Location

Hospital Psiquiátrico de Álava

Vitoria-Gasteiz, Spain

Location

Hospital Santiago Apostol

Vitoria-Gasteiz, Spain

Location

Danylo Galitsky Lviv State Medical University

Lviv, Lviv Oblast, Ukraine

Location

Odessa Regional Mental Hospital #2

S. Oleksandrivka, Odesa Oblast, Ukraine

Location

Vinnytsa National Medical University named by M.I. Pirogov

Vinnitsa, Vinnitsa, Ukraine

Location

Donetsk National Medical University n.a. M. Horkyy

Donetsk, Ukraine

Location

Public Institution "Institute of Neurology, Psychiatry and N

Kharkiv, Ukraine

Location

Kiev City Psychoneurological Hospital N 1, CNTRP

Kiev, Ukraine

Location

Odessa Regional Psychoneurology Dispensary

Odesa, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 25933099 DERIVED

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: March 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 27, 2016
• Results First Posted: January 26, 2015

Record last verified: 2016-04

Locations

BU (8); AU (2); US (46); AR (6); FR (3); ZA (7); UA (7); PL (4); CA (5); ES (4)