Status:
COMPLETED
A Study Evaluating the Efficacy of Administered Maintenance Treatments in Bipolar Disorder I and II.
Lead Sponsor:
AstraZeneca
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
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 episo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT01202604
Start Date
September 1 2010
End Date
December 1 2011
Last Update
December 20 2011
Active Locations (33)
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1
Research Site
Aigio, Achaias, Greece
2
Research Site
Ag. Paraskevi, Attikis, Greece
3
Research Site
Athens, Attikis, Greece
4
Research Site
Chaïdári, Attikis, Greece