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
This study has been completed.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
First received: February 25, 2011
Last updated: October 7, 2013
Last verified: October 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) [ Time Frame: at all post-baseline visits up to Week 8 ] [ Designated as safety issue: No ]
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a paient's depressive symptoms. The scale uses the DSM-IV criteria to measure symptoms or severity. Following the administration of the IDS-C30 by a qualified rater at the study center, each patient will complete an interactive computerized interview on a dedicated study laptop computer.
Secondary Outcome Measures:
- Clinical Global Impression of Severity (CGI-S) of depression rating [ Time Frame: at weeks 1, 2, 4, 6, 7,and 8, or last postbaseline observation ] [ Designated as safety issue: No ]
- Global Assessment of Functioning (GAF) Scale scores [ Time Frame: at weeks 4 and 8, or last postbaseline observation ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2013 (Final data collection date for primary outcome measure)
Armodafinil at 150 mg/day
Placebo Comparator: Placebo
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- The patient has a diagnosis of bipolar I disorder according to 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:
- 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.
- 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.
- The mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to the baseline visit.
- The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit.
- 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.
- The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305408
||Sponsor's Medical Expert
No publications provided
||Teva Pharmaceutical Industries ( Cephalon )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 25, 2011
||October 7, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Depressive Disorder, Major
Central Nervous System Stimulants
Physiological Effects of Drugs
Central Nervous System Agents