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

AstraZeneca88 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bipolar Disorder Bipolar Affective Psychosis Mania Manic Disorder Manic State

Interventions

Quetiapine 600mgDRUG

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

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (7)

Research Site

Guadalajara, Jalisco, Mexico

Research Site

Mexico City, Mexico City, Mexico

Research Site

Monterrey, Nuevo León, Mexico

Research Site

San Pedro Garza García, Nuevo León, Mexico

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline and 3 weeks

Secondary Outcomes

Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2.

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.

Time frame: Baseline and 1 week

Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3

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.

Time frame: Baseline and 2 weeks

Number of Participants With Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF)

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.

Time frame: 21 days ± 2 days or Last Observation Carried Forward

Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.