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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT01121536
First received: May 5, 2010
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Depression
Drug: Armodafinil
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Enrollment: 869
Study Start Date: April 2010
Study Completion Date: March 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Armodafinil
Drug: Armodafinil
Armodafinil 150 to 200 mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121536

  Show 33 Study Locations
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Sponsor's Medical Expert Cephalon
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01121536     History of Changes
Other Study ID Numbers: C10953/3074
Study First Received: May 5, 2010
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 21, 2014