A Study Evaluating the Efficacy of Administered Maintenance Treatments in Bipolar Disorder I and II.

AstraZeneca

Status: Completed

Conditions: Bipolar Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT01202604

NIS-NGR-DUM-2010/1

Details and patient eligibility

About

The primary objective of the study is to evaluate the efficacy of administered maintenance treatments in bipolar disorder I and II, defined as the percentage of patients who experience a relapse episode during the first 9 months after a mood event (manic or depressive).

Enrollment: 294 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who experienced the last acute mood episode during the last 2 months and are in euthymic state (YMRS score ≤12 and HAM-D score ≤12) for at least two weeks
• Diagnosis of bipolar disorder I or II (as per DSM-IV), with or without rapid cycling
• Subjects who have been treated with at least one atypical antipsychotic for the management of an acute mood event (manic or depressive) as monotherapy or in combination with other medication
• Provision of informed consent prior to study participation

Exclusion criteria

• Subjects fulfilling criteria for diagnosis of any other psychiatric condition (except from bipolar disorder I or II), as per DSM-IV Axis Ι, concomitant organic mental disorder or mental retardation
• Subjects who have received treatment with a depot
• Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria
• Inability of subjects to comply with the study protocol.

Trial design

294 participants in 1 patient group

Outpatients with bipolar disorder I or II (as per DSM-IV)

Description:

The percentage of patients who experience a relapse episode during the first 9 months after a mood event (manic or depressive).