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Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder. (EMMY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00521365
First received: August 24, 2007
Last updated: June 12, 2012
Last verified: March 2012
History of Changes

August 24, 2007
June 12, 2012
May 2008
August 2009   (final data collection date for primary outcome measure)
Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21) [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
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.
Change in YMRS total score from baseline to day 21 of treatment
Complete list of historical versions of study NCT00521365 on ClinicalTrials.gov Archive Site
  • Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2. [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 Carried Forward (LOCF). [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: Yes ]
  • Change in Waist Circumference From Baseline to Final Visit or Last Observation Carried Forward (LOCF). [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With >7% Increase in Weight [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with >7% increase in weight from baseline to end of study.
  • 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
Not Provided
Not Provided
 
Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder.
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.

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bipolar Disorder
  • Bipolar Affective Psychosis
  • Mania
  • Manic Disorder
  • Manic State
Drug: Quetiapine 600mg

300 mg quetiapine fumarate tablets for oral use.

Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
Experimental: Quetapine 600 mg
Intervention: Drug: Quetiapine 600mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with type I Bipolar Disorder in Manic phase according to standard scales and physician criteria.
  • Patients of both genders, aged 18-65 years old being at the first episode
  • Patients with chronic Bipolar Disorder with at least one previous manic episode 6 months before inclusion, that based on the physician experience are in a manic episode at study entry quality

Exclusion Criteria:

  • Psychoactive substance or alcohol abuse or dependence, forbidden medication, pregnancy, rapid cycling patients, intolerance to Quetiapine, clinically severe disease, unstable Diabetes Mellitus, neutropenia, other laboratory abnormalities
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00521365
D1443L00017
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Ana Polanco, MD AstraZeneca Mexico
Principal Investigator: Doris Gutierrez, MD INP
Study Chair: Julieta Jimenez AstraZeneca
AstraZeneca
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP