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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT01121536
First received: May 5, 2010
Last updated: March 19, 2013
Last verified: March 2013
History of Changes

May 5, 2010
March 19, 2013
April 2010
June 2013   (final data collection date for primary outcome measure)
Safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder whose most recent episode was a depressive episode [ Time Frame: Mean Change from Baseline to Week 1 and Months 1, 2, 4, and 6 (or last postbaseline observation) ] [ Designated as safety issue: Yes ]
as assessed by the occurrence of adverse events; by data obtained from clinical laboratory tests, vital signs, electrocardiograms, and physical examinations; and by scores from the Young Mania Rating Scale (YMRS), the Columbia Suicide Severity Rating Scale - Since Last Visit (C-SSRS-SLV), the Insomnia Severity Index (ISI), and the Hamilton Anxiety Scale (HAM-A)
Same as current
Complete list of historical versions of study NCT01121536 on ClinicalTrials.gov Archive Site
  • 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) [ Time Frame: Mean Change from Baseline to Week 1 ] [ Designated as safety issue: No ]
  • 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) [ Time Frame: Mean Change from Baseline to Month 1 ] [ Designated as safety issue: No ]
  • 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) [ Time Frame: Mean Change from Baseline to Month 2 ] [ Designated as safety issue: No ]
  • 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) [ Time Frame: Mean Change from Baseline to Month 4 ] [ Designated as safety issue: No ]
  • 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) [ Time Frame: Mean Change from Baseline to Month 6 (or last postbaseline observation) ] [ Designated as safety issue: No ]
  • 16-Item Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C16) [ Time Frame: Mean Change from Baseline to Week 1 ] [ Designated as safety issue: No ]
  • 16-Item Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C16) [ Time Frame: Mean Change from Baseline to Month 1 ] [ Designated as safety issue: No ]
  • 16-Item Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C16) [ Time Frame: Mean Change from Baseline to Month 2 ] [ Designated as safety issue: No ]
  • 16-Item Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C16) [ Time Frame: Mean Change from Baseline to Month 4 ] [ Designated as safety issue: No ]
  • 16-Item Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C16) [ Time Frame: Mean Change from Baseline to Month 6 (or last postbaseline observation) ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Severity (CGI-S) for depression [ Time Frame: Change from Baseline to Week 1 ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Severity (CGI-S) for depression [ Time Frame: Change from Baseline to Month 1 ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Severity (CGI-S) for depression [ Time Frame: Change from Baseline to Month 2 ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Severity (CGI-S) for depression [ Time Frame: Change from Baseline to Month 4 ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Severity (CGI-S) for depression [ Time Frame: Change from Baseline to Month 6 (or last postbaseline observation) ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning (GAF) Scale [ Time Frame: at Month 6 (or last postbaseline observation) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
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

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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
Drug: Armodafinil
Armodafinil 150 to 200 mg/day
Experimental: 1
Armodafinil
Intervention: Drug: Armodafinil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
900
June 2013
June 2013   (final data collection date for primary outcome measure)

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 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Croatia,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Poland,   Serbia,   Slovakia,   South Africa,   Spain,   Ukraine
 
NCT01121536
C10953/3074
Not Provided
Teva Pharmaceutical Industries ( Cephalon )
Cephalon
Not Provided
Study Director: Sponsor's Medical Expert Cephalon
Teva Pharmaceutical Industries
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP