Clinical trial NCT00521365: Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Bipolar Affective Psychosis
Mania
Manic Disorder
Manic State
Keywords: Bipolar Disorder
Bipolar Affective Psychosis
Mania
Manic Disorder
Manic State
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-08-27
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21)
timeFrame: Baseline and 3 weeks
Secondary outcomes:
measure: Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2.
timeFrame: Baseline and 1 week
measure: Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3
timeFrame: Baseline and 2 weeks
measure: Number of Participants With Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF)
timeFrame: 21 days ± 2 days or Last Observation Carried Forward
measure: Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF).
timeFrame: 21 days ± 2 days or Last Observation Carried Forward
measure: Change in the Clinical Global Impression (CGI) Total Score From Baseline (CGI-S) to Final Visit or Last Observation Carried Forward (LOCF)(CGI-I).
timeFrame: Baseline and 3 weeks
measure: Change in the Clinical Global Impression - Improvement (CGI-I) at Final Visit or Last Observation Carried Forward (LOCF).
timeFrame: Baseline and 3 weeks
measure: Change in the Quality of Life Questionnaire EQ5D Index From Baseline to End of the Study.
timeFrame: Baseline and 3 weeks
measure: Change in the Quality of Life Questionnaire EQ5D Visual Analogue Scale (VAS) From Baseline to Final Visit or Last Observation Carried Forward (LOCF).
timeFrame: Baseline and 3 weeks
measure: Change in the Simpson-Angus Scale (SAS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).
timeFrame: Baseline and 3 weeks
measure: Change in the Barnes Akathisia Rating Scale (BARS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).
timeFrame: Baseline and 3 weeks
measure: Change in Weight From Baseline to Final Visit or Last Observation Carried Forward (LOCF).
timeFrame: Baseline and 3 weeks
measure: Change in Waist Circumference From Baseline to Final Visit or Last Observation Carried Forward (LOCF).
timeFrame: Baseline and 3 weeks
measure: Number of Participants With >7% Increase in Weight
timeFrame: Baseline and 3 weeks
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Research Site
state: DF
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo Leon
city: San Pedro Garza García
country: Mexico
facility: Research Site
state: Nuevo Leon
city: Merida
country: Mexico
facility: Research Site
state: Yucatan
city: Durango
country: Mexico
facility: Research Site
city: San Luis Potosi
country: Mexico
facility: Research Site
Study officials:
affiliation: AstraZeneca Mexico
name: Ana Polanco, MD
role: STUDY_DIRECTOR
affiliation: INP
name: Doris Gutierrez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Julieta Jimenez
role: STUDY_CHAIR
References: