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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01072630




Registration number
NCT01072630
Ethics application status
Date submitted
19/02/2010
Date registered
22/02/2010
Date last updated
27/04/2016

Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Scientific title
A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Secondary ID [1] 0 0
2009-016634-27
Secondary ID [2] 0 0
C10953/3072
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Armodafinil
Treatment: Drugs - Placebo

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

Experimental: 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.

Experimental: 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.


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

Treatment: Drugs: Placebo
Matching Placebo, also in tablet form taken orally, once daily in the morning.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
Timepoint [1] 0 0
Day 0 (baseline), Week 8
Secondary outcome [1] 0 0
Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Timepoint [1] 0 0
Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Secondary outcome [2] 0 0
Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Timepoint [2] 0 0
Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Secondary outcome [3] 0 0
Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
Timepoint [3] 0 0
Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Secondary outcome [4] 0 0
Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
Timepoint [4] 0 0
Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Secondary outcome [5] 0 0
Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
Timepoint [5] 0 0
Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Secondary outcome [6] 0 0
Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale
Timepoint [6] 0 0
Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Secondary outcome [7] 0 0
Participants With Treatment-Emergent Adverse Events (TEAE)
Timepoint [7] 0 0
Day 1 to Week 9
Secondary outcome [8] 0 0
Change From Baseline to Endpoint in the Young Mania Rating Scale Total Score
Timepoint [8] 0 0
Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)
Secondary outcome [9] 0 0
Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score
Timepoint [9] 0 0
Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)
Secondary outcome [10] 0 0
Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score
Timepoint [10] 0 0
Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Secondary outcome [15] 0 0
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
Timepoint [15] 0 0
Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Secondary outcome [17] 0 0
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
Timepoint [17] 0 0
Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Secondary outcome [18] 0 0
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
Timepoint [18] 0 0
Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Secondary outcome [19] 0 0
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
Timepoint [19] 0 0
Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Secondary outcome [20] 0 0
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
Timepoint [20] 0 0
Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Secondary outcome [21] 0 0
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
Timepoint [21] 0 0
Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Secondary outcome [22] 0 0
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
Timepoint [22] 0 0
Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
492
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Neurotherapy Victoria Clinical Trials - Malvern
Recruitment hospital [2] 0 0
Northern Area Mental Health Services Northern Psychiatric R - Melbourne
Recruitment postcode(s) [1] 0 0
- Malvern
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Córdoba
Country [23] 0 0
Argentina
State/province [23] 0 0
Rosario
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Bourgas
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Pazardjik
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Pleven
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Plovdiv
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Sofia
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Varna
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
France
State/province [34] 0 0
Dole
Country [35] 0 0
France
State/province [35] 0 0
Jonzac
Country [36] 0 0
France
State/province [36] 0 0
Nîmes
Country [37] 0 0
Poland
State/province [37] 0 0
Bydgoszcz
Country [38] 0 0
Poland
State/province [38] 0 0
Gdansk
Country [39] 0 0
Poland
State/province [39] 0 0
Krakow
Country [40] 0 0
South Africa
State/province [40] 0 0
Cape Town
Country [41] 0 0
South Africa
State/province [41] 0 0
Centurion
Country [42] 0 0
South Africa
State/province [42] 0 0
Johannesburg
Country [43] 0 0
South Africa
State/province [43] 0 0
Paarl
Country [44] 0 0
South Africa
State/province [44] 0 0
Pretoria
Country [45] 0 0
Spain
State/province [45] 0 0
Coslada (Madrid)
Country [46] 0 0
Spain
State/province [46] 0 0
Pamplona
Country [47] 0 0
Spain
State/province [47] 0 0
Vitoria-Gasteiz
Country [48] 0 0
Spain
State/province [48] 0 0
Vitoria
Country [49] 0 0
Ukraine
State/province [49] 0 0
Odessa
Country [50] 0 0
Ukraine
State/province [50] 0 0
Donetsk
Country [51] 0 0
Ukraine
State/province [51] 0 0
Kharkiv
Country [52] 0 0
Ukraine
State/province [52] 0 0
Kiev
Country [53] 0 0
Ukraine
State/province [53] 0 0
Lviv
Country [54] 0 0
Ukraine
State/province [54] 0 0
Vinnitsa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cephalon
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01072630
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sponsor's Medical Expert
Address 0 0
Cephalon
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01072630