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OpenTrials
Completed

NCT Number: NCT01202604

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

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).

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mania Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aigio, Achaias, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The proportion of patients (n, %) who will experience a relapse episode (manic, hypomanic, depressive, mixed)

    Time frame: During the first 9 months after the acute mood episode or in case of relapse occurrence.

Secondary outcomes

  1. Description of administered treatments for the management of the acute phase of bipolar disorder [mood stabilizers (n,%), antidepressants (n,%), and antipsychotics (n,%)].

    Time frame: 4 months and 9 months after the acute mood episode or in case of relapse occurrence

  2. Description of management of relapse episodes in patients previously receiving treatment during the maintenance phase

    Time frame: In all visits - during the whole study period (9 months)

  3. YMRS total score, HAM-D total score

    Time frame: At baseline and final visit (9 months after the acute mood episode)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 16, 2010
Registry last updated
Dec 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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