Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

• ClinicalTrials.gov Identifier: NCT00481195
• Recruitment Status: Completed
• First Posted: June 1, 2007
• Results First Posted: December 20, 2010
• Last Update Posted: July 19, 2013
• Sponsor: Cephalon
• Information provided by (Responsible Party): Teva Branded Pharmaceutical Products R&D, Inc. ( Cephalon )

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Bipolar I Depression	Drug: Armodafinil; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 257 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: An 8 Week Double Blind, Placebo-Controlled, Parallel Group, Fixed Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
• Study Start Date: June 2007
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Armodafinil	Drug: Armodafinil; Patients were randomly assigned to begin oral treatment with armodafinil, which was titrated to 150 mg/day (3 tablets). Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo Comparator: Placebo	Drug: Placebo; Patients were randomly assigned to begin oral treatment with placebo, which was titrated to 3 tablets. Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.

Outcome Measures

Primary Outcome Measures :

1. 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) [ Time Frame: Baseline and 8 weeks from start of study drug administration (or last observation after baseline) ]
   The IDS C30 is a standardized 30 item, clinician rated scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Endpoint (either week 8 or the last observation after baseline) in the total score of the IDS-C30.

Secondary Outcome Measures :

1. The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) [ Time Frame: Baseline and 1 week following the start of study drug administration ]
   The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 1 in the total score of the IDS-C30.
2. The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) [ Time Frame: Baseline and 2 weeks following the start of study drug administration ]
   The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 2 in the total score of the IDS-C30.
3. The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) [ Time Frame: Baseline and 3 weeks following the start of study drug administration ]
   The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 3 in the total score of the IDS-C30.
4. The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]
   The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 4 in the total score of the IDS-C30.
5. The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) [ Time Frame: Baseline and 6 weeks following the start of study drug administration ]
   The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 6 in the total score of the IDS-C30.
6. The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]
   The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 8 in the total score of the IDS-C30.
7. Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) [ Time Frame: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline) ]
   The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a remission (total score <=11).
8. Number of Patients Achieving "Response" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) [ Time Frame: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline) ]
   The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a "response" (> 50% decrease from baseline in total score).
9. Number of Patients Achieving "Sustained Remission" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) [ Time Frame: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline) ]
   The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a "sustained remission" (total score <= 11 that persists over the four week period from Week 4 to Week 8).
10. Number of Patients Achieving "Sustained Response" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) [ Time Frame: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline) ]
    The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a "sustained response" (> 50% decrease from baseline in total score that persisted over the four week period between Week 4 and Week 8).
11. 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 [ Time Frame: Baseline and 8 weeks (or last observation after baseline) ]
    The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to Endpoint in the combined score of these three items assessing insomnia.
12. Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3 [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]
    The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 4 in the combined score of these three items assessing insomnia.
13. Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3 [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]
    The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 8 in the combined score of these three items assessing insomnia.
14. 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 [ Time Frame: Baseline and 8 weeks (or last observation after baseline) ]
    The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to Endpoint in the score of Item 4 assessing hypersomnia.
15. Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4 [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]
    The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 4 in the score of Item 4 assessing hypersomnia.
16. Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4 [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]
    The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 8 in the score of Item 4 assessing hypersomnia.
17. Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline and Endpoint (8 weeks following the start of study drug administration or last observation after baseline) ]
    The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the change in MADRS from Baseline to Endpoint.
18. Change From Baseline to Week 4 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]
    The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 4.
19. Change From Baseline to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]
    The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 8.
20. Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16) [ Time Frame: Baseline and 8 weeks (or last observation after baseline) ]
    The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Endpoint (Week 8 or last observation after baseline).
21. Change From Baseline to Week 1 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16) [ Time Frame: Baseline and 1 week following the start of study drug administration ]
    The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 1
22. Change From Baseline to Week 2 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16) [ Time Frame: Baseline and 2 weeks following the start of study drug administration ]
    The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 2
23. Change From Baseline to Week 3 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16) [ Time Frame: Baseline and 3 weeks following the start of study drug administration ]
    The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 3.
24. Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16) [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]
    The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 4.
25. Change From Baseline to Week 6 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16) [ Time Frame: Baseline and 6 weeks following the start of study drug administration ]
    The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 6.
26. Change From Baseline to Week 8 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16) [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]
    The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 8.
27. 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) [ Time Frame: Baseline and 8 weeks (or last observation after baseline) ]
    The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to endpoint (8 weeks or last observation after baseline).
28. Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]
    The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 4 weeks.
29. Change From Baseline to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]
    The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 8 weeks.
30. Change From Baseline to Endpoint (8 Weeks or Last Observation After Baseline) in Hamilton Anxiety Scale (HAM-A) Total Score [ Time Frame: baseline and 8 weeks (or last observation after baseline) ]
    The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety, 25-30 moderate to severe, >30 very severe. The data presented here summarizes the change in HAM-A score from Baseline to Endpoint (8 weeks or last observation after baseline).
31. Change From Baseline to 4 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]
    The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 4 Weeks
32. Change From Baseline to 8 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]
    The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 8 Weeks
33. 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) [ Time Frame: Baseline and 8 weeks (or last observation after baseline) ]
    CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of "much improved" or "very much improved". The number of responders at Endpoint are presented.
34. The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 1 [ Time Frame: Baseline and 1 week following the start of study drug administration ]
    CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of "much improved" or "very much improved". The number of responders at Week 1 are presented.
35. The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 2 [ Time Frame: Baseline and 2 weeks following the start of study drug administration ]
    CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of "much improved" or "very much improved". The number of responders at Week 2 are presented.
36. The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 3 [ Time Frame: Baseline and 3 weeks following the start of study drug administration ]
    CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of "much improved" or "very much improved". The number of responders at Week 3 are presented.
37. The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 4 [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]
    CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of "much improved" or "very much improved". The number of responders at Week 4 are presented.
38. The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 6 [ Time Frame: Baseline and 6 weeks following the start of study drug administration ]
    CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of "much improved" or "very much improved". The number of responders at Week 6 are presented.
39. The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 8 [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]
    CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of "much improved" or "very much improved". The number of responders at Week 8 are presented.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.)

Contacts and Locations

Locations

United States, Alabama

Birmingham Research Group

Birmingham, Alabama, United States, 35216

Birmingham Psychiatry Pharmaceutical Studies, Inc

Birmingham, Alabama, United States, 35226

United States, California

Synergy Clinical Research Center

Escondido, California, United States, 92025

Bay Area Research Institute

Lafayette, California, United States, 94549

Synergy Clinical Research Center

National City, California, United States, 91950

Excell Research

Oceanside, California, United States, 92056

Pacific Clinical Research Medical Group

Orange, California, United States, 92868

CNRI Los Angeles LLC

Pico Rivera, California, United States, 90660

Pacific Clinical Research Medical Group

Riverside, California, United States, 92506

California Neuropsychopharmacology Clinical Research Inst

San Diego, California, United States, 92126

Stanford University

Stanford, California, United States, 94305

United States, Florida

Clinical Neuroscience Solutions Inc

Jacksonville, Florida, United States, 32216

Fidelity Clinical Research

Lauderhill, Florida, United States, 33319

Stedman Clinical Trials, LLC

Tampa, Florida, United States, 33613

Janus Center for Psychiatric Research

West Palm Beach, Florida, United States, 33407

United States, Georgia

Atlanta Center for Clinical Research

Atlanta, Georgia, United States, 30308

Carman Research

Smyrna, Georgia, United States, 30080

United States, Illinois

Psychiatric Medicine Associates

Skokie, Illinois, United States, 60076

United States, Maryland

Capital Clinical Research Associates

Rockville, Maryland, United States, 20852

United States, New Jersey

CNS Research Institute

Clementon, New Jersey, United States, 08021

United States, New York

Behavioral Medical Research of Brooklyn

Brooklyn, New York, United States, 11201

Social Psychiatry Research Institute

Brooklyn, New York, United States, 11235

Social Psychiatry Research Institute

New York, New York, United States, 10021

Medical & Behavioral Health Research

New York, New York, United States, 10023

Behavioral Medical Research of Staten Island

Staten Island, New York, United States, 10305

United States, North Carolina

Richard Weisler, MD and Associates

Raleigh, North Carolina, United States, 27609

Piedmont Clinical Trials, Inc.

Winston-Salem, North Carolina, United States, 27104

United States, Ohio

Mood Disorders Program

Cleveland, Ohio, United States, 44106

Midwest Clinical Research Center

Dayton, Ohio, United States, 45408

United States, Oklahoma

Sooner Clinical Research

Oklahoma City, Oklahoma, United States, 73112

United States, Oregon

Oregon Center for Clinical Investigations, Inc.

Salem, Oregon, United States, 97301

United States, Pennsylvania

Dubois Regional Medical Center - Behavioral Health Services

Dubois, Pennsylvania, United States, 15801

Keystone Clinical Studies LLC

Norristown, Pennsylvania, United States, 19401

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

CRI Worldwide

Philadelphia, Pennsylvania, United States, 19139

United States, Tennessee

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States, 38119

United States, Texas

Community Clinical Research

Austin, Texas, United States, 78754

Claghorn-Lesem Research Clinic, LTD

Bellaire, Texas, United States, 77401

University Hills Clinical Research

Irving, Texas, United States, 75062

Grayline Clinical Drug Trials

Wichita Falls, Texas, United States, 76309

United States, Washington

Northwest Clinical Research Center

Bellevue, Washington, United States, 98004

Eastside Therapeutic Resource

Kirkland, Washington, United States, 98033

Bulgaria

Call For Information

Burgas, Bulgaria, 8000

Call For Information - Center Site #2

Plovdiv, Bulgaria, 4002

Call For Information

Plovdiv, Bulgaria, 4002

Call For Information - Center Site #2

Sofia, Bulgaria, 1113

Call For Information

Sofia, Bulgaria, 1113

Hungary

Call For Information

Budapest, Hungary, H-1135

Call For Information

Nagykálló, Hungary, H-4321

Romania

Call For Information

Bucuresti, Romania, 010604

Call For Information

Bucuresti, Romania, 030455

Call For Information - Center Site #2

Bucuresti, Romania, 041915

Call For Information

Bucuresti, Romania, 041915

Call For Information

Pitesti, Romania, 110069

Call For Information

Targoviste, Romania, 190081

Sponsors and Collaborators

Cephalon

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Calabrese JR, Ketter TA, Youakim JM, Tiller JM, Yang R, Frye MA. Adjunctive armodafinil for major depressive episodes associated with bipolar I disorder: a randomized, multicenter, double-blind, placebo-controlled, proof-of-concept study. J Clin Psychiatry. 2010 Oct;71(10):1363-70. doi: 10.4088/JCP.09m05900gry. Epub 2010 Jul 27.

• Responsible Party: Cephalon
• ClinicalTrials.gov Identifier: NCT00481195
• Obsolete Identifiers: NCT00547222
• Other Study ID Numbers: C10953/2032/DP/US
• First Posted: June 1, 2007
• Results First Posted: December 20, 2010
• Last Update Posted: July 19, 2013
• Last Verified: July 2013

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Modafinil; Central Nervous System Stimulants; Physiological Effects of Drugs; Wakefulness-Promoting Agents; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 Enzyme Inducers; Molecular Mechanisms of Pharmacological Action