Clinical trial NCT01121536: Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Official title: A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Depression
Keywords: Bipolar I Disorder
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-12
Enrollment: 867
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Key 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.

Key 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.

Primary outcomes:
measure: Participants With Treatment-Emergent Adverse Events (TEAE)
timeFrame: Day 1 up to Month 6
measure: Participants With Clinically Significant Abnormal Serum Chemistry Values
timeFrame: Day 1 to Month 6
measure: Participants With Clinically Significant Abnormal Hematology Values
timeFrame: Day 1 to Month 6
measure: Participants With Clinically Significant Abnormal Urinalysis Values
timeFrame: Day 1 to Month 6
measure: Participants With Clinically Significant Abnormal Vital Signs Values
timeFrame: Day 1 to Month 6
measure: Change From Baseline to Endpoint in Electrocardiogram (ECG) Values
timeFrame: Day 0 (baseline), Month 6 or last post-baseline observation
measure: Physical Examination Shifts From Baseline to Endpoint
timeFrame: Day 0 (baseline), Month 6 (or last post-baseline observation)
measure: Change From Baseline to Endpoint in Body Weight
timeFrame: Day 0 (baseline), Month 6 (or last post-baseline observation)
measure: Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score
timeFrame: Day 0 (baseline), Month 6 or last post-baseline observation
measure: Participants With Findings During the Open-Label Study on the Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV)
timeFrame: Day 1, Week 1, Months 1, 2, 4 and 6 or last post-baseline visit
measure: Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score
timeFrame: Day 0 (baseline), Month 6 (or last post-baseline observation)
measure: Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score
timeFrame: Day 0 (baseline), Month 6 or last post-baseline observation
Secondary outcomes:
measure: Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
timeFrame: Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)
measure: Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
timeFrame: Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)
measure: Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Clinical Global Impression of Severity (CGI-S) for Depression
timeFrame: Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)
measure: Change From Baseline to Endpoint in the Global Assessment for Functioning (GAF) Scale
timeFrame: Day 0 (baseline), Month 6 or the last post-baseline assessment)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 113
state: Alabama
city: Birmingham
country: United States
facility: Teva Investigational Site 225
state: Alabama
city: Anaheim
country: United States
facility: Teva Investigational Site 229
state: California
city: Cerritos
country: United States
facility: Teva Investigational Site 217
state: California
city: Cerritos
country: United States
facility: Teva Investigational Site 223
state: California
city: Garden Grove
country: United States
facility: Teva Investigational Site 115
state: California
city: Imperial
country: United States
facility: Teva Investigational Site 121
state: California
city: Oceanside
country: United States
facility: Teva Investigational Site 303
state: California
city: Oceanside
country: United States
facility: Teva Investigational Site 400
state: California
city: Pico Rivera
country: United States
facility: Teva Investigational Site 200
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 128
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 201
state: California
city: Santa Ana
country: United States
facility: Teva Investigational Site 192
state: California
city: Santa Ana
country: United States
facility: Teva Investigational Site 292
state: California
city: Sherman Oaks
country: United States
facility: Teva Investigational Site 295
state: California
city: Temecula
country: United States
facility: Teva Investigational Site 122
state: California
city: Gainesville
country: United States
facility: Teva Investigational Site 131
state: Florida
city: Jacksonville Beach
country: United States
facility: Teva Investigational Site 606
state: Florida
city: Jacksonville
country: United States
facility: Teva Investigational Site 132
state: Florida
city: Lauderhill
country: United States
facility: Teva Investigational Site 127
state: Florida
city: North Miami
country: United States
facility: Teva Investigational Site 119
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 118
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 608
state: Florida
city: Atlanta
country: United States
facility: Teva Investigational Site 205
state: Georgia
city: Atlanta
country: United States
facility: Teva Investigational Site 116
state: Georgia
city: Smyrna
country: United States
facility: Teva Investigational Site 204
state: Georgia
city: Naperville
country: United States
facility: Teva Investigational Site 107
state: Illinois
city: Naperville
country: United States
facility: Teva Investigational Site 301
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Teva Investigational Site 219
state: Illinois
city: Park Ridge
country: United States
facility: Teva Investigational Site 195
state: Illinois
city: Lafayette
country: United States
facility: Teva Investigational Site 600
state: Indiana
city: Pikesville
country: United States
facility: Teva Investigational Site 300
state: Maryland
city: Watertown
country: United States
facility: Teva Investigational Site 603
state: Massachusetts
city: Flowood
country: United States
facility: Teva Investigational Site 290
state: Mississippi
city: Saint Louis
country: United States
facility: Teva Investigational Site 133
state: Missouri
city: Mount Laurel
country: United States
facility: Teva Investigational Site 103
state: New Jersey
city: Mount Laurel
country: United States
facility: Teva Investigational Site 212
state: New Jersey
city: Albuquerque
country: United States
facility: Teva Investigational Site 193
state: New Mexico
city: Brooklyn
country: United States
facility: Teva Investigational Site 207
state: New York
city: Brooklyn
country: United States
facility: Teva Investigational Site 104
state: New York
city: New York
country: United States
facility: Teva Investigational Site 202
state: New York
city: Rochester
country: United States
facility: Teva Investigational Site 129
state: New York
city: Staten Island
country: United States
facility: Teva Investigational Site 411
state: New York
city: Staten Island
country: United States
facility: Teva Investigational Site 110
state: New York
city: Raleigh
country: United States
facility: Teva Investigational Site 105
state: North Carolina
city: Beachwood
country: United States
facility: Teva Investigational Site 190
state: Ohio
city: Canton
country: United States
facility: Teva Investigational Site 213
state: Ohio
city: Cincinnati
country: United States
facility: Teva Investigational Site 610
state: Ohio
city: Dayton
country: United States
facility: Teva Investigational Site 102
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 401
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 609
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 616
state: Oklahoma
city: Allentown
country: United States
facility: Teva Investigational Site 406
state: Pennsylvania
city: Media
country: United States
facility: Teva Investigational Site 117
state: Pennsylvania
city: Memphis
country: United States
facility: Teva Investigational Site 106
state: Tennessee
city: Austin
country: United States
facility: Teva Investigational Site 111
state: Texas
city: DeSoto
country: United States
facility: Teva Investigational Site 403
state: Texas
city: Friendswood
country: United States
facility: Teva Investigational Site 612
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 228
state: Texas
city: Irving
country: United States
facility: Teva Investigational Site 224
state: Texas
city: Orem
country: United States
facility: Teva Investigational Site 409
state: Utah
city: Salt Lake City
country: United States
facility: Teva Investigational Site 408
state: Utah
city: Richmond
country: United States
facility: Teva Investigational Site 404
state: Virginia
city: Bellevue
country: United States
facility: Teva Investigational Site 100
state: Washington
city: Kirkland
country: United States
facility: Teva Investigational Site 613
state: Washington
city: Spokane
country: United States
facility: Teva Investigational Site 605
state: Washington
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 237
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 450
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 881
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 884
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 136
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 134
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 235
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 462
city: Cordoba
country: Argentina
facility: Teva Investigational Site 135
city: Cordoba
country: Argentina
facility: Teva Investigational Site 236
city: La Plata, Buenos Aires
country: Argentina
facility: Teva Investigational Site 138
city: La Plata
country: Argentina
facility: Teva Investigational Site 371
city: Rosario
country: Argentina
facility: Teva Investigational Site 238
city: Brisbane
country: Australia
facility: Teva Investigational Site 141
city: Malvern
country: Australia
facility: Teva Investigational Site 240
city: Rio de Janeiro
country: Brazil
facility: Teva Investigational Site 624
city: Bourgas
country: Bulgaria
facility: Teva Investigational Site 248
city: Kardzhali
country: Bulgaria
facility: Teva Investigational Site 146
city: Kazanlak
country: Bulgaria
facility: Teva Investigational Site 148
city: Pazardjik
country: Bulgaria
facility: Teva Investigational Site 853
city: Pleven
country: Bulgaria
facility: Teva Investigational Site 852
city: Plovdiv
country: Bulgaria
facility: Teva Investigational Site 249
city: Plovdiv
country: Bulgaria
facility: Teva Investigational Site 145
city: Ruse
country: Bulgaria
facility: Teva Investigational Site 370
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 147
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 854
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 855
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 247
city: Varna
country: Bulgaria
facility: Teva Investigational Site 851
city: Varna
country: Bulgaria
facility: Teva Investigational Site 245
city: Kelowna
country: Canada
facility: Teva Investigational Site 198
city: Mississauga
country: Canada
facility: Teva Investigational Site 296
city: Mississauga
country: Canada
facility: Teva Investigational Site 196
city: Penticton
country: Canada
facility: Teva Investigational Site 299
city: Rijeka
country: Croatia
facility: Teva Investigational Site 635
city: Zagreb
country: Croatia
facility: Teva Investigational Site 633
city: Zagreb
country: Croatia
facility: Teva Investigational Site 634
city: Dole
country: France
facility: Teva Investigational Site 286
city: Nimes
country: France
facility: Teva Investigational Site 153
city: Achim
country: Germany
facility: Teva Investigational Site 655
city: Dresden
country: Germany
facility: Teva Investigational Site 651
city: Budapest
country: Hungary
facility: Teva Investigational Site 661
city: Budapest
country: Hungary
facility: Teva Investigational Site 664
city: Budapest
country: Hungary
facility: Teva Investigational Site 662
city: Nagykallo
country: Hungary
facility: Teva Investigational Site 666
city: Catania
country: Italy
facility: Teva Investigational Site 688
city: Firenze
country: Italy
facility: Teva Investigational Site 689
city: Pisa
country: Italy
facility: Teva Investigational Site 687
city: Rome
country: Italy
facility: Teva Investigational Site 692
city: Bialystok
country: Poland
facility: Teva Investigational Site 259
city: Gdansk
country: Poland
facility: Teva Investigational Site 258
city: Gdansk
country: Poland
facility: Teva Investigational Site 257
city: Kielce
country: Poland
facility: Teva Investigational Site 156
city: Krakow
country: Poland
facility: Teva Investigational Site 155
city: Leszno
country: Poland
facility: Teva Investigational Site 256
city: Skorzewo
country: Poland
facility: Teva Investigational Site 255
city: Szczecin
country: Poland
facility: Teva Investigational Site 861
city: Tuszyn
country: Poland
facility: Teva Investigational Site 157
city: Belgrade
country: Serbia
facility: Teva Investigational Site 832
city: Belgrade
country: Serbia
facility: Teva Investigational Site 175
city: Belgrade
country: Serbia
facility: Teva Investigational Site 177
city: Belgrade
country: Serbia
facility: Teva Investigational Site 831
city: Belgrade
country: Serbia
facility: Teva Investigational Site 833
city: Kragujevac
country: Serbia
facility: Teva Investigational Site 176
city: Nis
country: Serbia
facility: Teva Investigational Site 837
city: Novi Knezevac
country: Serbia
facility: Teva Investigational Site 834
city: Bratislava
country: Slovakia
facility: Teva Investigational Site 699
city: Rimavska Sobota
country: Slovakia
facility: Teva Investigational Site 697
city: Roznava
country: Slovakia
facility: Teva Investigational Site 696
city: Trencin
country: Slovakia
facility: Teva Investigational Site 698
city: Cape Town
country: South Africa
facility: Teva Investigational Site 712
city: Cape Town
country: South Africa
facility: Teva Investigational Site 709
city: Centurion
country: South Africa
facility: Teva Investigational Site 708
city: Johannesburg
country: South Africa
facility: Teva Investigational Site 710
city: Paarl
country: South Africa
facility: Teva Investigational Site 711
city: Pretoria
country: South Africa
facility: Teva Investigational Site 706
city: Alcoy
country: Spain
facility: Teva Investigational Site 336
city: Coslada (Madrid)
country: Spain
facility: Teva Investigational Site 434
city: Vitoria-Gasteiz
country: Spain
facility: Teva Investigational Site 430
city: Vitoria
country: Spain
facility: Teva Investigational Site 433
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 181
city: Donetsk
country: Ukraine
facility: Teva Investigational Site 872
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 282
city: Kiev
country: Ukraine
facility: Teva Investigational Site 281
city: Lugansk
country: Ukraine
facility: Teva Investigational Site 180
city: Lviv
country: Ukraine
facility: Teva Investigational Site 873
city: Odessa
country: Ukraine
facility: Teva Investigational Site 280
city: Odessa
country: Ukraine
facility: Teva Investigational Site 875
city: Poltava
country: Ukraine
facility: Teva Investigational Site 183
city: S. Oleksandrivka
country: Ukraine
facility: Teva Investigational Site 871
city: Simferopol
country: Ukraine
facility: Teva Investigational Site 184
city: Vinnytsya
country: Ukraine
facility: Teva Investigational Site 182
Study officials:
affiliation: Cephalon
name: Sponsor's Medical Expert
role: STUDY_DIRECTOR
References: