valproic acid and Depression, Involutional

valproic acid has been researched along with Depression, Involutional in 41 studies

Valproic Acid: A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.
valproic acid : A branched-chain saturated fatty acid that comprises of a propyl substituent on a pentanoic acid stem.

Depression, Involutional: Form of depression in those MIDDLE AGE with feelings of ANXIETY.

Research

Studies (41)

Authors

Clinical Trials (6)

Trial Overview

Trial Outcomes

MADRS Score - Baseline

Antidepressant effects were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). It is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. (NCT00088699)
Timeframe: Baseline

MADRS Score - Day 1 Following Intervention

Antidepressant effects were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). It is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. (NCT00088699)
Timeframe: Day 1

Change From Baseline to 4 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score

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 (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

Change From Baseline to 8 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score

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 (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

Change From Baseline to Endpoint (8 Weeks or Last Observation After Baseline) in Hamilton Anxiety Scale (HAM-A) Total Score

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). (NCT00481195)
Timeframe: baseline and 8 weeks (or last observation after baseline)

Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

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. (NCT00481195)
Timeframe: Baseline and Endpoint (8 weeks following the start of study drug administration or last observation after baseline)

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)

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). (NCT00481195)
Timeframe: Baseline and 8 weeks (or last observation after baseline)

Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

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). (NCT00481195)
Timeframe: Baseline and 8 weeks (or last observation after baseline)

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

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. (NCT00481195)
Timeframe: Baseline and 8 weeks (or last observation after baseline)

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

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. (NCT00481195)
Timeframe: Baseline and 8 weeks (or last observation after baseline)

Change From Baseline to Week 1 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

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 (NCT00481195)
Timeframe: Baseline and 1 week following the start of study drug administration

Change From Baseline to Week 2 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

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 (NCT00481195)
Timeframe: Baseline and 2 weeks following the start of study drug administration

Change From Baseline to Week 3 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

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. (NCT00481195)
Timeframe: Baseline and 3 weeks following the start of study drug administration

Change From Baseline to Week 4 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

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. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

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. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

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. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4

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. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3

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. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

Change From Baseline to Week 6 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

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. (NCT00481195)
Timeframe: Baseline and 6 weeks following the start of study drug administration

Change From Baseline to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

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. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

Change From Baseline to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

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. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

Change From Baseline to Week 8 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

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. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4

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. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3

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. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

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)

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. (NCT00481195)
Timeframe: Baseline and 8 weeks from start of study drug administration (or last observation after baseline)

The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (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 1 in the total score of the IDS-C30. (NCT00481195)
Timeframe: Baseline and 1 week following the start of study drug administration

The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (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. (NCT00481195)
Timeframe: Baseline and 2 weeks following the start of study drug administration

The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (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. (NCT00481195)
Timeframe: Baseline and 3 weeks following the start of study drug administration

The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (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. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (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. (NCT00481195)
Timeframe: Baseline and 6 weeks following the start of study drug administration

The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (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. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

"Number of Patients Achieving Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (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 response (> 50% decrease from baseline in total score)." (NCT00481195)
Timeframe: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)

"Number of Patients Achieving Sustained Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (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 sustained remission (total score <= 11 that persists over the four week period from Week 4 to Week 8)." (NCT00481195)
Timeframe: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)

"Number of Patients Achieving Sustained Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (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 sustained response (> 50% decrease from baseline in total score that persisted over the four week period between Week 4 and Week 8)." (NCT00481195)
Timeframe: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)

Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (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). (NCT00481195)
Timeframe: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)

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)

"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." (NCT00481195)
Timeframe: Baseline and 8 weeks (or last observation after baseline)

The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 1

"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." (NCT00481195)
Timeframe: Baseline and 1 week following the start of study drug administration

The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 2

"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." (NCT00481195)
Timeframe: Baseline and 2 weeks following the start of study drug administration

The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 3

"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." (NCT00481195)
Timeframe: Baseline and 3 weeks following the start of study drug administration

The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 4

"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." (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 6

"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." (NCT00481195)
Timeframe: Baseline and 6 weeks following the start of study drug administration

The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 8

"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." (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)

CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scored from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values. (NCT00483548)
Timeframe: Baseline, Week 6

Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values. (NCT00483548)
Timeframe: Baseline, Week 6

Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6

Number of subjects with improvement defined as CGI-I response of 1 (very much improved) or 2 (much improved). CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected. (NCT00483548)
Timeframe: Baseline, Week 6

MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6

Number of subjects with MADRS total score ≤ 12 (indicates remission). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). (NCT00483548)
Timeframe: Week 6

MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6

Number of subjects with reduction of ≥50 percent (%) in MADRS total score (indicates response). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Reduction calculated as ([A-B]/B*100): A=value at observation; B=baseline value. (NCT00483548)
Timeframe: Week 6

CGI-Improvement Score

CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected. Week 6 is the primary timepoint. (NCT00483548)
Timeframe: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Scores

AIMS is a clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe); items 11 to 14 are No or Yes response to dental status and sleep movements and are assessed separately. AIMS total score is sum of first 7 items. Change calculated as a difference between post-baseline observation and baseline AIMS score values. (NCT00483548)
Timeframe: Baseline, Week 2, Week 4, Week 6

Change From Baseline in Barnes Akathisia Rating Scale (BARS or BAS)

BARS is a clinician rated scale to evaluate akathisia associated with use of antipsychotic medications: objective motor restlessness, range 0 to 3; subjective complaints of restlessness and associated distress, range 0 to 3; global clinical assessment of akathisia, range 0 to 5. Higher scores indicate more affected. Change calculated as a difference between post-baseline observation and baseline BARS score values. (NCT00483548)
Timeframe: Baseline, Week 2, Week 4, Week 6

Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6)

CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values. (NCT00483548)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5

Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6

GAF is a clinician rated scale to measure the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale (single score of 1 to 100) with 100 indicating a superior level of function. Change calculated as a difference between post-baseline observation and baseline GAF score values. (NCT00483548)
Timeframe: Baseline, Week 6

Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score

HAM-A is a clinician rated 14-item scale that rates the intensity of psychic anxiety (items 1 to 6 and item 14) and somatic anxiety (items 7 to 13) on a 5-point severity scale; scores range from 0 (not present) to 4 (very severe); lower score indicates less affected. Change calculated as a difference between post-baseline observation and baseline HAM-A score values. Week 6 is the primary timepoint. (NCT00483548)
Timeframe: Baseline, Week 2, Week 4, Week 6

Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)

MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values. (NCT00483548)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5

Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6

Q-LES-Q is a 16-item subject rated scale to measure satisfaction with areas of daily functioning (physical health, social relationships, medication, and overall life satisfaction); rated on a 5-point Likert scale: higher scores indicate greater enjoyment and satisfaction with general life activities. Scores for items 1 to 14 are summed for a total score and converted to 0 to 100 range. Items 15 and 16 measure satisfaction with medication and overall satisfaction and are analyzed separately. Change calculated as a difference between post-baseline observation and baseline Q-LES-Q score values. (NCT00483548)
Timeframe: Baseline, Week 6

Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3)

SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values. (NCT00483548)
Timeframe: Baseline, Week 6

Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5)

SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values. (NCT00483548)
Timeframe: Baseline, Week 6

Change From Baseline in Simpson Angus Scale (SAS) Score

SAS is a clinician rated 10-item scale to measure extrapyramidal side effects (Parkinsonism or Parkinsonian side effects induced with antipsychotics); rated on a 5-point scale with range 0 (absence of condition) to 4 (presence of condition in extreme form). Global score is sum of all scores divided by the total number of items. Change calculated as a difference between post-baseline observation and baseline SAS score values. (NCT00483548)
Timeframe: Baseline, Week 2, Week 4, Week 6

Change From Baseline in Young Mania Rating Scale (YMRS) Total Score

YMRS is clinician rated 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Higher scores indicate greater severity. Change calculated as a difference between post-baseline observation and baseline YMRS score values. Week 6 is the primary timepoint. (NCT00483548)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

Reviews

9 reviews available for valproic acid and Depression, Involutional

Trials

11 trials available for valproic acid and Depression, Involutional

Other Studies

21 other studies available for valproic acid and Depression, Involutional