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

NCT ID: NCT01121536

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 867 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-10-31

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Armodafinil 150-200 mg/day

Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.

Group Type: EXPERIMENTAL

Armodafinil

Intervention Type: DRUG

Armodafinil tablets, taken orally, once daily in the morning

Interventions

Armodafinil

Armodafinil tablets, taken orally, once daily in the morning

Intervention Type: DRUG

Other Intervention Names

CEP-10953; Nuvigil

Eligibility Criteria

Inclusion Criteria

• The patient has completed 8 weeks of treatment in a Cephalon-sponsored Phase 3, double-blind study of armodafinil treatment in patients with major depression associated with bipolar I disorder.
• The patient met criteria for enrollment in the previous double-blind study and, in the opinion of the investigator, is in need of continued treatment for depression.
• During the previous double-blind study, the patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium; valproic acid; olanzapine; quetiapine; aripiprazole; lamotrigine; risperidone; ziprasidone, (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:

1. The mood stabilizers must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation.

2. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.

3. The patient must be judged by the investigator to be compliant with treatment with the mood stabilizer(s).

4. The patient must be willing to continue treatment with the same protocol-allowed mood stabilizer(s) at dosages considered appropriate by the investigator.

• The patient has a Young Mania Rating Scale (YMRS) total score of 14 or less at the enrollment visit. Patients who have a YMRS score of 12 through 14 must be discussed with the medical monitor to determine their suitability for enrollment.

Exclusion Criteria

• The patient has any Axis I or Axis II disorder apart from bipolar I disorder that became the primary focus of treatment during the double-blind study.
• The patient has psychotic symptoms or had psychosis during the double-blind study.
• 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 met criteria for alcohol or substance abuse or dependence (with the exception of nicotine dependence) during the double-blind study.
• The patient has any history of homicidal ideation or significant aggression or currently has homicidal or significant aggressive ideation.

• 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

Teva Investigational Site 113

Birmingham, Alabama, United States

Teva Investigational Site 225

Birmingham, Alabama, United States

Teva Investigational Site 229

Anaheim, California, United States

Teva Investigational Site 217

Cerritos, California, United States

Teva Investigational Site 223

Cerritos, California, United States

Teva Investigational Site 115

Garden Grove, California, United States

Teva Investigational Site 121

Imperial, California, United States

Teva Investigational Site 303

Oceanside, California, United States

Teva Investigational Site 400

Oceanside, California, United States

Teva Investigational Site 200

Pico Rivera, California, United States

Teva Investigational Site 128

San Diego, California, United States

Teva Investigational Site 201

San Diego, California, United States

Teva Investigational Site 192

Santa Ana, California, United States

Teva Investigational Site 292

Santa Ana, California, United States

Teva Investigational Site 295

Sherman Oaks, California, United States

Teva Investigational Site 122

Temecula, California, United States

Teva Investigational Site 131

Gainesville, Florida, United States

Teva Investigational Site 132

Jacksonville, Florida, United States

Teva Investigational Site 606

Jacksonville Beach, Florida, United States

Teva Investigational Site 127

Lauderhill, Florida, United States

Teva Investigational Site 119

North Miami, Florida, United States

Teva Investigational Site 118

Tampa, Florida, United States

Teva Investigational Site 608

Tampa, Florida, United States

Teva Investigational Site 205

Atlanta, Georgia, United States

Teva Investigational Site 116

Atlanta, Georgia, United States

Teva Investigational Site 204

Smyrna, Georgia, United States

Teva Investigational Site 107

Naperville, Illinois, United States

Teva Investigational Site 301

Naperville, Illinois, United States

Teva Investigational Site 219

Oakbrook Terrace, Illinois, United States

Teva Investigational Site 195

Park Ridge, Illinois, United States

Teva Investigational Site 600

Lafayette, Indiana, United States

Teva Investigational Site 300

Pikesville, Maryland, United States

Teva Investigational Site 603

Watertown, Massachusetts, United States

Teva Investigational Site 290

Flowood, Mississippi, United States

Teva Investigational Site 133

St Louis, Missouri, United States

Teva Investigational Site 103

Mount Laurel, New Jersey, United States

Teva Investigational Site 212

Mount Laurel, New Jersey, United States

Teva Investigational Site 193

Albuquerque, New Mexico, United States

Teva Investigational Site 207

Brooklyn, New York, United States

Teva Investigational Site 104

Brooklyn, New York, United States

Teva Investigational Site 202

New York, New York, United States

Teva Investigational Site 129

Rochester, New York, United States

Teva Investigational Site 411

Staten Island, New York, United States

Teva Investigational Site 110

Staten Island, New York, United States

Teva Investigational Site 105

Raleigh, North Carolina, United States

Teva Investigational Site 190

Beachwood, Ohio, United States

Teva Investigational Site 213

Canton, Ohio, United States

Teva Investigational Site 610

Cincinnati, Ohio, United States

Teva Investigational Site 102

Dayton, Ohio, United States

Teva Investigational Site 401

Oklahoma City, Oklahoma, United States

Teva Investigational Site 609

Oklahoma City, Oklahoma, United States

Teva Investigational Site 616

Oklahoma City, Oklahoma, United States

Teva Investigational Site 406

Allentown, Pennsylvania, United States

Teva Investigational Site 117

Media, Pennsylvania, United States

Teva Investigational Site 106

Memphis, Tennessee, United States

Teva Investigational Site 111

Austin, Texas, United States

Teva Investigational Site 403

DeSoto, Texas, United States

Teva Investigational Site 612

Friendswood, Texas, United States

Teva Investigational Site 228

Houston, Texas, United States

Teva Investigational Site 224

Irving, Texas, United States

Teva Investigational Site 409

Orem, Utah, United States

Teva Investigational Site 408

Salt Lake City, Utah, United States

Teva Investigational Site 404

Richmond, Virginia, United States

Teva Investigational Site 100

Bellevue, Washington, United States

Teva Investigational Site 613

Kirkland, Washington, United States

Teva Investigational Site 605

Spokane, Washington, United States

Teva Investigational Site 237

Buenos Aires, , Argentina

Teva Investigational Site 450

Buenos Aires, , Argentina

Teva Investigational Site 881

Buenos Aires, , Argentina

Teva Investigational Site 884

Buenos Aires, , Argentina

Teva Investigational Site 136

Buenos Aires, , Argentina

Teva Investigational Site 134

Buenos Aires, , Argentina

Teva Investigational Site 235

Buenos Aires, , Argentina

Teva Investigational Site 462

Buenos Aires, , Argentina

Teva Investigational Site 135

Córdoba, , Argentina

Teva Investigational Site 236

Córdoba, , Argentina

Teva Investigational Site 371

La Plata, , Argentina

Teva Investigational Site 138

La Plata, Buenos Aires, , Argentina

Teva Investigational Site 238

Rosario, , Argentina

Teva Investigational Site 141

Brisbane, , Australia

Teva Investigational Site 240

Malvern, , Australia

Teva Investigational Site 624

Rio de Janeiro, , Brazil

Teva Investigational Site 248

Burgas, , Bulgaria

Teva Investigational Site 146

Kardzhali, , Bulgaria

Teva Investigational Site 148

Kazanlak, , Bulgaria

Teva Investigational Site 853

Pazardzhik, , Bulgaria

Teva Investigational Site 852

Pleven, , Bulgaria

Teva Investigational Site 249

Plovdiv, , Bulgaria

Teva Investigational Site 145

Plovdiv, , Bulgaria

Teva Investigational Site 370

Rousse, , Bulgaria

Teva Investigational Site 147

Sofia, , Bulgaria

Teva Investigational Site 854

Sofia, , Bulgaria

Teva Investigational Site 855

Sofia, , Bulgaria

Teva Investigational Site 247

Sofia, , Bulgaria

Teva Investigational Site 851

Varna, , Bulgaria

Teva Investigational Site 245

Varna, , Bulgaria

Teva Investigational Site 198

Kelowna, , Canada

Teva Investigational Site 296

Mississauga, , Canada

Teva Investigational Site 196

Mississauga, , Canada

Teva Investigational Site 299

Penticton, , Canada

Teva Investigational Site 635

Rijeka, , Croatia

Teva Investigational Site 633

Zagreb, , Croatia

Teva Investigational Site 634

Zagreb, , Croatia

Teva Investigational Site 286

Dole, , France

Teva Investigational Site 153

Nîmes, , France

Teva Investigational Site 655

Achim, , Germany

Teva Investigational Site 651

Dresden, , Germany

Teva Investigational Site 661

Budapest, , Hungary

Teva Investigational Site 664

Budapest, , Hungary

Teva Investigational Site 662

Budapest, , Hungary

Teva Investigational Site 666

Nagykálló, , Hungary

Teva Investigational Site 688

Catania, , Italy

Teva Investigational Site 689

Florence, , Italy

Teva Investigational Site 687

Pisa, , Italy

Teva Investigational Site 692

Rome, , Italy

Teva Investigational Site 259

Bialystok, , Poland

Teva Investigational Site 258

Gdansk, , Poland

Teva Investigational Site 257

Gdansk, , Poland

Teva Investigational Site 156

Kielce, , Poland

Teva Investigational Site 155

Krakow, , Poland

Teva Investigational Site 256

Leszno, , Poland

Teva Investigational Site 255

Skorzewo, , Poland

Teva Investigational Site 861

Szczecin, , Poland

Teva Investigational Site 157

Tuszyn, , Poland

Teva Investigational Site 832

Belgrade, , Serbia

Teva Investigational Site 175

Belgrade, , Serbia

Teva Investigational Site 177

Belgrade, , Serbia

Teva Investigational Site 831

Belgrade, , Serbia

Teva Investigational Site 833

Belgrade, , Serbia

Teva Investigational Site 176

Kragujevac, , Serbia

Teva Investigational Site 837

Niš, , Serbia

Teva Investigational Site 834

Novi Kneževac, , Serbia

Teva Investigational Site 699

Bratislava, , Slovakia

Teva Investigational Site 697

Rimavská Sobota, , Slovakia

Teva Investigational Site 696

Rožňava, , Slovakia

Teva Investigational Site 698

Trenčín, , Slovakia

Teva Investigational Site 712

Cape Town, , South Africa

Teva Investigational Site 709

Cape Town, , South Africa

Teva Investigational Site 708

Centurion, , South Africa

Teva Investigational Site 710

Johannesburg, , South Africa

Teva Investigational Site 711

Paarl, , South Africa

Teva Investigational Site 706

Pretoria, , South Africa

Teva Investigational Site 336

Alcoy, , Spain

Teva Investigational Site 434

Coslada (Madrid), , Spain

Teva Investigational Site 433

Vitoria-Gasteiz, , Spain

Teva Investigational Site 430

Vitoria-Gasteiz, , Spain

Teva Investigational Site 181

Dnipropetrovsk, , Ukraine

Teva Investigational Site 872

Donetsk, , Ukraine

Teva Investigational Site 282

Kharkiv, , Ukraine

Teva Investigational Site 281

Kiev, , Ukraine

Teva Investigational Site 180

Luhansk, , Ukraine

Teva Investigational Site 873

Lviv, , Ukraine

Teva Investigational Site 280

Odesa, , Ukraine

Teva Investigational Site 875

Odesa, , Ukraine

Teva Investigational Site 183

Poltava, , Ukraine

Teva Investigational Site 871

S. Oleksandrivka, , Ukraine

Teva Investigational Site 184

Simferopol, , Ukraine

Teva Investigational Site 182

Vinnytsia, , Ukraine

Countries

United States; Argentina; Australia; Brazil; Bulgaria; Canada; Croatia; France; Germany; Hungary; Italy; Poland; Serbia; Slovakia; South Africa; Spain; Ukraine

Other Identifiers

2009-016648-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C10953/3074

Identifier Type: -

Identifier Source: org_study_id