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

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT01202604
• Lead Sponsor: AstraZeneca

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-16
• Status Verified: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2011-12-19
• Last Update Posted: 2011-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients (n, %) who will experience a relapse episode (manic, hypomanic, depressive, mixed)	During the first 9 months after the acute mood episode or in case of relapse occurrence.

Secondary Outcome Measures

Name	Time	Method
Description of administered treatments for the management of the acute phase of bipolar disorder [mood stabilizers (n,%), antidepressants (n,%), and antipsychotics (n,%)].	4 months and 9 months after the acute mood episode or in case of relapse occurrence
Description of management of relapse episodes in patients previously receiving treatment during the maintenance phase	In all visits - during the whole study period (9 months)
YMRS total score, HAM-D total score	At baseline and final visit (9 months after the acute mood episode)

Trial Locations

Locations (1)

Research Site; 🇬🇷 Serres, Greece