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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01121536




Registration number
NCT01121536
Ethics application status
Date submitted
5/05/2010
Date registered
12/05/2010
Date last updated
21/09/2018

Titles & IDs
Public title
Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Scientific 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
Secondary ID [1] 0 0
2009-016648-38
Secondary ID [2] 0 0
C10953/3074
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

Experimental: 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.


Treatment: Drugs: Armodafinil
Armodafinil tablets, 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
Participants With Treatment-Emergent Adverse Events (TEAE)
Timepoint [1] 0 0
Day 1 up to Month 6
Primary outcome [2] 0 0
Participants With Clinically Significant Abnormal Serum Chemistry Values
Timepoint [2] 0 0
Day 1 to Month 6
Primary outcome [3] 0 0
Participants With Clinically Significant Abnormal Hematology Values
Timepoint [3] 0 0
Day 1 to Month 6
Primary outcome [4] 0 0
Participants With Clinically Significant Abnormal Urinalysis Values
Timepoint [4] 0 0
Day 1 to Month 6
Primary outcome [5] 0 0
Participants With Clinically Significant Abnormal Vital Signs Values
Timepoint [5] 0 0
Day 1 to Month 6
Primary outcome [6] 0 0
Change From Baseline to Endpoint in Electrocardiogram (ECG) Values
Timepoint [6] 0 0
Day 0 (baseline), Month 6 or last post-baseline observation
Primary outcome [7] 0 0
Physical Examination Shifts From Baseline to Endpoint
Timepoint [7] 0 0
Day 0 (baseline), Month 6 (or last post-baseline observation)
Primary outcome [8] 0 0
Change From Baseline to Endpoint in Body Weight
Timepoint [8] 0 0
Day 0 (baseline), Month 6 (or last post-baseline observation)
Primary outcome [9] 0 0
Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score
Timepoint [9] 0 0
Day 0 (baseline), Month 6 or last post-baseline observation
Primary outcome [10] 0 0
Participants With Findings During the Open-Label Study on the Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV)
Timepoint [10] 0 0
Day 1, Week 1, Months 1, 2, 4 and 6 or last post-baseline visit
Primary outcome [11] 0 0
Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score
Timepoint [11] 0 0
Day 0 (baseline), Month 6 (or last post-baseline observation)
Primary outcome [12] 0 0
Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score
Timepoint [12] 0 0
Day 0 (baseline), Month 6 or last post-baseline observation
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)
Secondary outcome [4] 0 0
Change From Baseline to Endpoint in the Global Assessment for Functioning (GAF) Scale
Timepoint [4] 0 0
Day 0 (baseline), Month 6 or the last post-baseline assessment)

Eligibility
Key inclusion criteria
Key

* 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
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 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2013
Sample size
Target
Accrual to date
Final
867
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Teva Investigational Site 141 - Brisbane
Recruitment hospital [2] 0 0
Teva Investigational Site 240 - Malvern
Recruitment postcode(s) [1] 0 0
4053 - Brisbane
Recruitment postcode(s) [2] 0 0
3144 - Malvern
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
Florida
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State/province [4] 0 0
Georgia
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State/province [5] 0 0
Illinois
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Indiana
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Maryland
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Massachusetts
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Mississippi
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Missouri
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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La Plata, Buenos Aires
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La Plata
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Argentina
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Rosario
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Brazil
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Rio de Janeiro
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Bulgaria
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Bourgas
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Bulgaria
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Kardzhali
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Bulgaria
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Kazanlak
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Bulgaria
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Pazardjik
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Bulgaria
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Pleven
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Plovdiv
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Ruse
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Bulgaria
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Sofia
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Varna
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Canada
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Kelowna
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Canada
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Mississauga
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Canada
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Penticton
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Croatia
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Rijeka
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Croatia
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Zagreb
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France
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Dole
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France
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Nimes
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Germany
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Achim
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Germany
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Dresden
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Budapest
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Hungary
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Nagykallo
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Italy
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Catania
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Italy
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Firenze
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Pisa
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Italy
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Rome
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Kielce
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Krakow
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Leszno
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Skorzewo
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Szczecin
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Nis
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Serbia
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Novi Knezevac
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Slovakia
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Bratislava
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Slovakia
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Rimavska Sobota
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Slovakia
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Roznava
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Trencin
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South Africa
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Cape Town
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Centurion
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South Africa
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Johannesburg
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South Africa
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Paarl
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South Africa
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Pretoria
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Spain
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Alcoy
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Spain
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Coslada (Madrid)
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Spain
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Vitoria-Gasteiz
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Spain
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Vitoria
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Ukraine
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Kharkiv
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Kiev
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Lugansk
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Lviv
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Odessa
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Poltava
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S. Oleksandrivka
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Simferopol
Country [88] 0 0
Ukraine
State/province [88] 0 0
Vinnytsya

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01121536
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/study/NCT01121536