Phase 3
Completed N=399
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
Source: ClinicalTrials.gov NCT01305408 ↗Enrolled (actual)
399
Serious AEs
2.8%
Results posted
Jan 2015
Primary outcomePrimary: Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) — -19.4; -20.8 units on a scale — p=0.2717
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) |
-19.4; -20.8 | 0.2717 |
| SECONDARY Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score |
2; 3; 13; 9; 21; 27 | — |
| SECONDARY Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score |
.5; 1; 2; 2; 5; 7 | — |
| SECONDARY Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) |
-6.0; -5.3; -10.0; -8.9; -13.4; -13.5 | — |
| SECONDARY Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16) |
-2.4; -2.1; -4.2; -3.4; -5.3; -5.3 | — |
| SECONDARY Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression |
-0.2; -0.2; -0.5; -0.5; -0.7; -0.9 | — |
| SECONDARY Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale |
5.8; 8.2; 11.5; 15.3; 10.6; 13.6 | — |
| SECONDARY Participants With Treatment-Emergent Adverse Events (TEAE) |
71; 89; 4; 4; 32; 53 | — |
| SECONDARY Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score |
-1.0; -0.9 | — |
| SECONDARY Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score |
-4.2; -4.3 | — |
| SECONDARY Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score |
-7.0; -7.1 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
6; 5; 2; 6; 1; 7 | — |
| SECONDARY 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 |
2; 0; 0; 0; 0; 1 | — |
| SECONDARY 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 |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
1; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
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, 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.
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.
Data sourced from ClinicalTrials.gov (NCT01305408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.