Phase 2
N=257
Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Bipolar I Depression
Bottom Line
View on ClinicalTrials.gov: NCT00481195 ↗Enrolled (actual)
257
Serious AEs
2.4%
Results posted
Dec 2010
Primary outcome: Primary: The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) — -15.6; -12.5 Units on a scale — p=0.0439
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Armodafinil (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cephalon
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) |
-15.6; -12.5 | 0.0439 sig |
| SECONDARY The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) |
-6.5; -4.8 | 0.0795 |
| SECONDARY The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) |
-10.0; -7.3 | 0.0272 sig |
| SECONDARY The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) |
-13.1; -10.7 | 0.0802 |
| SECONDARY The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) |
-13.7; -12.1 | 0.2407 |
| SECONDARY The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) |
-16.7; -13.7 | 0.0502 |
| SECONDARY The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) |
-17.8; -14.8 | 0.0612 |
| SECONDARY Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) |
30; 22; 94; 101 | 0.1980 |
| SECONDARY Number of Patients Achieving "Response" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) |
46; 47; 78; 76 | 0.8960 |
| SECONDARY Number of Patients Achieving "Sustained Remission" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) |
13; 8; 111; 115 | 0.2575 |
| SECONDARY Number of Patients Achieving "Sustained Response" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) |
23; 17; 101; 106 | 0.3129 |
| SECONDARY Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3 |
-1.6; -1.2 | 0.1565 |
| SECONDARY Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3 |
-1.2; -1.1 | 0.6737 |
| SECONDARY Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3 |
-2.0; -1.6 | 0.2249 |
| SECONDARY Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4 |
-0.4; -0.2 | 0.0862 |
| SECONDARY Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4 |
-0.2; -0.2 | 0.9281 |
| SECONDARY Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4 |
-0.3; -0.2 | 0.4428 |
| SECONDARY Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
-12.3; -10.2 | 0.0965 |
| SECONDARY Change From Baseline to Week 4 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
-9.6; -8.9 | 0.5389 |
| SECONDARY Change From Baseline to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
-13.4; -11.0 | 0.0793 |
| SECONDARY Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16) |
-7.0; -6.5 | 0.3814 |
| SECONDARY Change From Baseline to Week 1 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16) |
-3.5; -3.7 | 0.8099 |
| SECONDARY Change From Baseline to Week 2 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16) |
-5.0; -4.1 | 0.0968 |
| SECONDARY Change From Baseline to Week 3 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16) |
-5.8; -5.0 | 0.1605 |
| SECONDARY Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16) |
-6.4; -5.6 | 0.1869 |
| SECONDARY Change From Baseline to Week 6 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16) |
-7.8; -6.7 | 0.0817 |
| SECONDARY Change From Baseline to Week 8 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16) |
-8.2; -7.6 | 0.3712 |
| SECONDARY Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) |
8.2; 7.4 | 0.5427 |
| SECONDARY Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) |
5.9; 4.6 | 0.3463 |
| SECONDARY Change From Baseline to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) |
10.1; 8.5 | 0.2730 |
| SECONDARY Change From Baseline to Endpoint (8 Weeks or Last Observation After Baseline) in Hamilton Anxiety Scale (HAM-A) Total Score |
-4.1; -3.9 | 0.7791 |
| SECONDARY Change From Baseline to 4 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score |
-3.6; -3.5 | 0.9007 |
| SECONDARY Change From Baseline to 8 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score |
-4.7; -4.4 | 0.6431 |
| SECONDARY The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Endpoint (Week 8 or Last Observation After Baseline) |
64; 60; 60; 62 | 0.6631 |
| SECONDARY The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 1 |
12; 12; 107; 105 | 0.9768 |
| SECONDARY The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 2 |
25; 26; 83; 84 | 0.9873 |
| SECONDARY The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 3 |
38; 32; 64; 68 | 0.4567 |
| SECONDARY The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 4 |
46; 42; 53; 55 | 0.6475 |
| SECONDARY The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 6 |
47; 43; 45; 49 | 0.5066 |
| SECONDARY The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 8 |
52; 47; 37; 41 | 0.4438 |
Summary
The primary objective of the study is to determine if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to their current treatment for a current major depressive episode.
Eligibility Criteria
Key Inclusion Criteria
- The patient has a diagnosis of Bipolar I Disorder and is currently experiencing a major depressive episode.
- The patient is currently being treated with 1 or 2 of the following drugs: lithium, olanzapine, or valproic acid.
Key Exclusion Criteria
- The patient has any Axis I disorder apart from Bipolar I Disorder that was the primary focus of treatment within 6 months before the screening visit (with the exception of nicotine dependence).
- The patient has any clinically significant uncontrolled medical or surgical condition.
- The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
- The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
Data sourced from ClinicalTrials.gov (NCT00481195). 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.