Clinical trial NCT01305408: Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Official title: A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: Bipolar I Disorder
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-28
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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, quetiapine, risperidone, ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:

  1. The mood stabilizer(s) must have been taken a minimum 4 weeks before the onset of the major depressive episode and still be taken at the time of the screening visit at dose or blood level considered appropriate for maintenance therapy by the patient's physician.
  2. The patient must continue to take the same mood stabilizer(s) during the screening period; no mood stabilizer may be added during the screening period.
  3. The mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to the baseline visit.
  4. The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit.
  5. The mood stabilizer(s) must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation.
  6. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.

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.

Primary outcomes:
measure: Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
timeFrame: Day 0 (baseline), Week 8
Secondary outcomes:
measure: Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
timeFrame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
timeFrame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
timeFrame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
timeFrame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
timeFrame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale
timeFrame: Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)
measure: Participants With Treatment-Emergent Adverse Events (TEAE)
timeFrame: Day 1 to Week 9
measure: Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score
timeFrame: Day 0 (baseline), last postbaseline observation (up to 8 weeks)
measure: Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score
timeFrame: Day 0 (baseline), last postbaseline observation (up to 8 weeks)
measure: Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score
timeFrame: Day 0 (baseline), last postbaseline observation (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 225
state: Alabama
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: Jacksonville Beach
country: United States
facility: Teva Investigational Site 606
state: Florida
city: Lauderhill
country: United States
facility: Teva Investigational Site 127
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 608
state: Florida
city: Atlanta
country: United States
facility: Teva Investigational Site 116
state: Georgia
city: Atlanta
country: United States
facility: Teva Investigational Site 205
state: Georgia
city: Park Ridge
country: United States
facility: Teva Investigational Site 195
state: Illinois
city: Indianapolis
country: United States
facility: Teva Investigational Site 611
state: Indiana
city: Lafayette
country: United States
facility: Teva Investigational Site 600
state: Indiana
city: Watertown
country: United States
facility: Teva Investigational Site 603
state: Massachusetts
city: Brooklyn
country: United States
facility: Teva Investigational Site 207
state: New York
city: New York
country: United States
facility: Teva Investigational Site 202
state: New York
city: Staten Island
country: United States
facility: Teva Investigational Site 110
state: New York
city: Staten Island
country: United States
facility: Teva Investigational Site 411
state: New York
city: Wilmington
country: United States
facility: Teva Investigational Site 614
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Investigational Site 610
state: Ohio
city: Toledo
country: United States
facility: Teva Investigational Site 615
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: Desoto
country: United States
facility: Teva Investigational Site 403
state: Texas
city: Friendswood
country: United States
facility: Teva Investigational Site 612
state: Texas
city: Salt Lake City
country: United States
facility: Teva Investigational Site 408
state: Utah
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 134
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 136
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 888
city: Córdoba Capital
country: Argentina
facility: Teva Investigational Site 135
city: Córdoba
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: La Plata
country: Argentina
facility: Teva Investigational Site 886
city: Mendoza
country: Argentina
facility: Teva Investigational Site 882
city: Mendoza
country: Argentina
facility: Teva Investigational Site 883
city: Mendoza
country: Argentina
facility: Teva Investigational Site 885
city: Mendoza
country: Argentina
facility: Teva Investigational Site 887
city: Rosario
country: Argentina
facility: Teva Investigational Site 238
city: Belo Horizonte
country: Brazil
facility: Teva Investigational Site 623
city: Curitiba-Parana
country: Brazil
facility: Teva Investigational Site 626
city: Distrito de Rubiao Junior
country: Brazil
facility: Teva Investigational Site 621
city: Itapira -Sao Paulo
country: Brazil
facility: Teva Investigational Site 627
city: Rio de Janeiro
country: Brazil
facility: Teva Investigational Site 624
city: Salvador
country: Brazil
facility: Teva Investigational Site 622
city: Sao Paolo
country: Brazil
facility: Teva Investigational Site 628
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 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 149
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 244
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 247
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 854
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 855
city: Varna
country: Bulgaria
facility: Teva Investigational Site 245
city: Varna
country: Bulgaria
facility: Teva Investigational Site 851
city: Varna
country: Bulgaria
facility: Teva Investigational Site 856
city: Rijeka
country: Croatia
facility: Teva Investigational Site 635
city: Split
country: Croatia
facility: Teva Investigational Site 631
city: Zagreb
country: Croatia
facility: Teva Investigational Site 632
city: Zagreb
country: Croatia
facility: Teva Investigational Site 633
city: Zagreb
country: Croatia
facility: Teva Investigational Site 634
city: Helsinki
country: Finland
facility: Teva Investigational Site 716
city: Helsinki
country: Finland
facility: Teva Investigational Site 717
city: Kangasala
country: Finland
facility: Teva Investigational Site 719
city: Turku
country: Finland
facility: Teva Investigational Site 718
city: Achim
country: Germany
facility: Teva Investigational Site 655
city: Berlin
country: Germany
facility: Teva Investigational Site 656
city: Cologne
country: Germany
facility: Teva Investigational Site 653
city: Dresden
country: Germany
facility: Teva Investigational Site 651
city: Freiburg
country: Germany
facility: Teva Investigational Site 654
city: Mittweida
country: Germany
facility: Teva Investigational Site 652
city: Budapest
country: Hungary
facility: Teva Investigational Site 661
city: Budapest
country: Hungary
facility: Teva Investigational Site 662
city: Budapest
country: Hungary
facility: Teva Investigational Site 664
city: Gyor
country: Hungary
facility: Teva Investigational Site 665
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: Genova
country: Italy
facility: Teva Investigational Site 686
city: Lido di Camaiore(LU)
country: Italy
facility: Teva Investigational Site 691
city: Naples
country: Italy
facility: Teva Investigational Site 690
city: Pisa
country: Italy
facility: Teva Investigational Site 687
city: Pisa
country: Italy
facility: Teva Investigational Site 693
city: Roma
country: Italy
facility: Teva Investigational Site 692
city: Bialystok
country: Poland
facility: Teva Investigational Site 259
city: Gdansk
country: Poland
facility: Teva Investigational Site 257
city: Gdynia
country: Poland
facility: Teva Investigational Site 258
city: Krakow
country: Poland
facility: Teva Investigational Site 155
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 177
city: Belgrade
country: Serbia
facility: Teva Investigational Site 831
city: Belgrade
country: Serbia
facility: Teva Investigational Site 832
city: Belgrade
country: Serbia
facility: Teva Investigational Site 835
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: Bojnice
country: Slovakia
facility: Teva Investigational Site 700
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 707
city: Cape Town
country: South Africa
facility: Teva Investigational Site 709
city: Cape Town
country: South Africa
facility: Teva Investigational Site 712
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: 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 875
city: Poltava
country: Ukraine
facility: Teva Investigational Site 183
city: s. Oleksandrivka
country: Ukraine
facility: Teva Investigational Site 871
city: Vinnytsya
country: Ukraine
facility: Teva Investigational Site 182
Study officials:
affiliation: Cephalon
name: Sponsor's Medical Expert
role: STUDY_DIRECTOR
References:
citation: Frye MA, Amchin J, Bauer M, Adler C, Yang R, Ketter TA. Randomized, placebo-controlled, adjunctive study of armodafinil for bipolar I depression: implications of novel drug design and heterogeneity of concurrent bipolar maintenance treatments. Int J Bipolar Disord. 2015 Dec;3(1):34. doi: 10.1186/s40345-015-0034-0. Epub 2015 Sep 2.