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

Study Overview
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Brief Summary
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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).

Official Title
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Prospective, Observational Study for the Maintenance Treatment of Patients With Bipolar Disorder I and II in Greece.

Conditions
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Bipolar Disorder

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Outpatients with bipolar disorder I or II (as per DSM-IV)<br>The percentage of patients who experience a relapse episode during the first 9 months after a mood event (manic or depressive). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar disorder I and II, mood event, manic or depressive, Greece