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A Study Evaluating the Efficacy of Administered Maintenance Treatments in Bipolar Disorder I and II. | Clinical Trials | Clareo Health

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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.

NCT01202604•AstraZeneca

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 65 years

Sex

ALL

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.

Locations (33)

Research Site

Aigio, Achaias, Greece

Research Site

Ag. Paraskevi, Attikis, Greece

Research Site

Athens, Attikis, Greece

Research Site

Chaïdári, Attikis, Greece

Research Site

Drapetsona, Attikis, Greece

Research Site

Elefsina, Attikis, Greece

Research Site

Glyfada, Attikis, Greece

Research Site

Ilissia, Attikis, Greece

Research Site

Kifissia, Attikis, Greece

Research Site

Koropí, Attikis, Greece

Key Dates

Start Date

September 1, 2010

Primary Completion Date

December 1, 2011

Completion Date

December 1, 2011

Last Updated

December 20, 2011

Enrollment

294

ACTUAL participants

Conditions

Bipolar Disorder

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 20, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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