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

Phase 4

Completed

• Conditions: Bipolar Disorder; Manic Disorder; Mania; Manic State; Bipolar Affective Psychosis
• Interventions: Drug: Quetiapine 600mg

• Registration Number: NCT00521365
• Lead Sponsor: AstraZeneca

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 Description

Not available

Study Timeline

• Study First Submitted: 2007-08-24
• Study First Submitted QC: 2007-08-24
• Study First Posted: 2007-08-27
• Study Start: 2008-05
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2010-08-11
• Status Verified: 2012-03
• Results First Submitted QC: 2012-06-12
• Last Update Submitted: 2012-06-12
• Results First Posted: 2012-07-17
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Quetapine 600 mg	Quetiapine 600mg	-

Primary Outcome Measures

Name	Time	Method
Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21)	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.

Secondary Outcome Measures

Name	Time	Method
Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3	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)	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.
Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2.	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.
Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF).	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).	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 Quality of Life Questionnaire EQ5D Index From Baseline to End of the Study.	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 Clinical Global Impression - Improvement (CGI-I) at Final Visit or Last Observation Carried Forward (LOCF).	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 Visual Analogue Scale (VAS) From Baseline to Final Visit or Last Observation Carried Forward (LOCF).	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 Waist Circumference From Baseline to Final Visit or Last Observation Carried Forward (LOCF).	Baseline and 3 weeks
Change in the Simpson-Angus Scale (SAS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).	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).	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 Carried Forward (LOCF).	Baseline and 3 weeks
Number of Participants With >7% Increase in Weight	Baseline and 3 weeks	Number of participants with \>7% increase in weight from baseline to end of study.

Trial Locations

Locations (1)

Research Site; 🇲🇽 San Luis Potosi, Mexico