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

NCT ID: NCT01202604

Last Updated: 2011-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

294 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-12-31

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).

Detailed Description

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Conditions

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Bipolar Disorder

Keywords

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Bipolar disorder I and II mood event manic or depressive Greece

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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

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

No interventions assigned to this group

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Panagiotis Pontikis

Role: STUDY_DIRECTOR

AstraZeneca S.A. Greece

Locations

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Research Site

Aigio, Achaias, Greece

Site Status

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Ag. Paraskevi, Attikis, Greece

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Athens, Attikis, Greece

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Chaïdári, Attikis, Greece

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Drapetsona, Attikis, Greece

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Elefsina, Attikis, Greece

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Glyfada, Attikis, Greece

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Ilissia, Attikis, Greece

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Kifissia, Attikis, Greece

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Koropí, Attikis, Greece

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Marousi, Attikis, Greece

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N. Kosmos, Attikis, Greece

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Pangrati, Attikis, Greece

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Petroúpolis, Attikis, Greece

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Piraeus, Attikis, Greece

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Thebes, Attikis, Greece

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Vironas, Attikis, Greece

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Ag. Nikolaos, Crete, Greece

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Agrinio, Etoloakarnania, Greece

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Arta, Etoloakarnania, Greece

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Alexandroupoli, Evros, Greece

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Lamia, Fhiotidos, Greece

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Amaliáda, Ilias, Greece

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Karditsa, Karditsas, Greece

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Katerini, Katerinis, Greece

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Kavala, Kavalas, Greece

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Sparti, Lakonias, Greece

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Edessa, Pellas, Greece

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Giannitsá, Pellas, Greece

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Preveza, Prevezis, Greece

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Serres, Serres, Greece

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Thessaloniki, Thessalonikis, Greece

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Trikala, Trikalon, Greece

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Countries

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Greece

Other Identifiers

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NIS-NGR-DUM-2010/1

Identifier Type: -

Identifier Source: org_study_id