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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01202604

Enrollment

294

Registered

2010-09-16

Start date

2010-09-30

Completion date

2011-12-31

Last updated

2011-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Bipolar disorder I and II, mood event, manic or depressive, Greece

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	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

Measure	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)

Countries

Greece

Outcome results