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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
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Bipolar Affective Psychosis
Mania
Manic Disorder
Manic State
Drug: Quetiapine 600mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 88
Study Start Date: May 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quetapine 600 mg 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.


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521365

Locations
Mexico
Research Site
Mexico, DF, Mexico
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Monterrey, Nuevo Leon, Mexico
Research Site
San Pedro Garza García, Nuevo Leon, Mexico
Research Site
Merida, Yucatan, Mexico
Research Site
Durango, Mexico
Research Site
San Luis Potosi, Mexico
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Ana Polanco, MD AstraZeneca Mexico
Principal Investigator: Doris Gutierrez, MD INP
Study Chair: Julieta Jimenez AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00521365     History of Changes
Other Study ID Numbers: D1443L00017
Study First Received: August 24, 2007
Results First Received: August 11, 2010
Last Updated: June 12, 2012
Health Authority: Mexico: Ministry of Health

Keywords provided by AstraZeneca:
Bipolar Disorder
Bipolar Affective Psychosis
Mania
Manic Disorder
Manic State

Additional relevant MeSH terms:
Affective Disorders, Psychotic
Bipolar Disorder
Disease
Mental Disorders
Mood Disorders
Pathologic Processes
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014