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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Manic Disorder; Manic State; Bipolar Disorder; Mania; Bipolar Affective Psychosis

Treatments: Drug: Quetiapine 600mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00521365

D1443L00017

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Quetapine 600 mg

Experimental group

Treatment:

Drug: Quetiapine 600mg