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

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.

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.

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.

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.

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.

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.

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).

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).

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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

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

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.

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.

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.

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.

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).

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.

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.

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).

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

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

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.

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.

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.

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.

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.

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.

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.