Clinical Trial: Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase IV STudy of the Effectiveness of Quetiapine Extended Release 600mg Once a Day to Control the Symptoms of Manic Phase of Bipolar Disorder.

Brief Summary: The primary purpose of the study is to assess the efficacy of Quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to Bipolar disorder. This trial will also assess the life quality and productivity loss improvement for patients from baseline to day 21.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21) [ Time Frame: Baseline and 3 weeks ]

Change in the YMRS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF), modified intention to treat (mITT) population. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.


Original Primary Outcome: Change in YMRS total score from baseline to day 21 of treatment

Current Secondary Outcome:

  • Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2. [ Time Frame: Baseline and 1 week ]
    Change in the YMRS total score from baseline to visit 2 (1 week) ,. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60.
  • Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3 [ Time Frame: Baseline and 2 weeks ]
    Change in the YMRS total score from baseline to visit 3(2 weeks). YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60.
  • Number of Participants With Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF) [ Time Frame: 21 days ± 2 days or Last Observation Carried Forward ]

    Number of participants that had Young Mania Rating Scale (YMRS) response at Final Visit or Last Observation Carried Forward (LOCF). A patient is scored as responder if the change from inclusion shows a reduction of 6 points in the YMRS total score.

    YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.

  • Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF). [ Time Frame: 21 days ± 2 days or Last Observation Carried Forward ]

    Number of participants that had Young Mania Rating Scale (YMRS) remission at Final Visit or Last Observation Carried Forward (LOCF). A patient is classified in remission if his/her final YMRS total score was ≤11.

    YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.

  • Change in the Clinical Global Impression (CGI) Total Score From Baseline (CGI-S) to Final Visit or Last Observation Carried Forward (LOCF)(CGI-I). [ Time Frame: Baseline and 3 weeks ]
    Clinical Global Impression-Severity(CGI-S)is a measurement of illness severity evaluated at baseline. Clinical Global Impression-Improvement(CGI-I)is a measurement of improvement taken at Final Visit (FV) or Last Observation Carried Forward(LOCF).Change CGI Total score is assessed with next equation: CGI-I total score at FV or LOCF - CGI-S score. CGI-S Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Normal 7=the most extremely ill patients. CGI-I Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Very much improved; 4= No change; 7=Very much worse.
  • Change in the Clinical Global Impression - Improvement (CGI-I) at Final Visit or Last Observation Carried Forward (LOCF). [ Time Frame: Baseline and 3 weeks ]
    Change in the CGI- I at Final Visit or Last Observation Carried Forward (LOCF). CGI I Questionnaire has a one item with scale range 0 to 7. 0=patients who ere not assessed, 1=Very much improved; 4= No change; 7=Very much worse.
  • Change in the Quality of Life Questionnaire EQ5D Index From Baseline to End of the Study. [ Time Frame: Baseline and 3 weeks ]
    Total possible index score is 0-1(0=The worsen quality of life; 1=The best Quality of life).
  • Change in the Quality of Life Questionnaire EQ5D Visual Analogue Scale (VAS) From Baseline to Final Visit or Last Observation Carried Forward (LOCF). [ Time Frame: Baseline and 3 weeks ]
    Change from baseline to Final Visit or Last Observation Carried Forward (LOCF). Quality of Life Questionnaire (EQ5D) part 2 has 1 item with continuous scale range 0 to 100. 0=The worsen Quality of Life; 100=The best Quality of life.
  • Change in the Simpson-Angus Scale (SAS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF). [ Time Frame: Baseline and 3 weeks ]

    Change in the Simpson-Angus Scale (SAS) total score from baseline to Final Visit or Last Observation Carried Forward (LOCF).

    SAS Questionnaire has a 6 items with scale range 0 to 3 for each item.0=Normal; 3=Most abnormal. Total possible score is 0-18.

  • Change in the Barnes Akathisia Rating Scale (BARS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF). [ Time Frame: Baseline and 3 weeks ]
    Change in the BARS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF). BARS Questionnaire has 4 items with scale range 0 to 3 for 3 items and 0 to 5 for 1 item. 0=Normal; 3 or 5=Most abnormal. Total possible score is 0-14.
  • Change in Weight From Baseline to Final Visit or Last Observation

    Original Secondary Outcome:

    • To evaluate if Quetiapine improves health related quality of life of patients with Bipolar Mania
    • To evaluate the safety and tolerability of Quetiapine in the treatment of patients of Bipolar Mania


    Information By: AstraZeneca

    Dates:
    Date Received: August 24, 2007
    Date Started: May 2008
    Date Completion:
    Last Updated: June 12, 2012
    Last Verified: March 2012