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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01202604
First received: September 14, 2010
Last updated: December 19, 2011
Last verified: December 2011
  Purpose

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).


Condition
Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective, Observational Study for the Maintenance Treatment of Patients With Bipolar Disorder I and II in Greece.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • YMRS total score, HAM-D total score [ Time Frame: At baseline and final visit (9 months after the acute mood episode) ] [ Designated as safety issue: No ]

Enrollment: 294
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Outpatients diagnosed with bipolar disorder I or II (as per DSM-IV), who have received therapy with at least one atypical antipsychotic for the acute episode and whose treating physician has considered they have entered the maintenance phase.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202604

Locations
Greece
Research Site
Aigio, Achaias, Greece
Research Site
Ag. Paraskevi, Attikis, Greece
Research Site
Athens, Attikis, Greece
Research Site
Chaidari, Attikis, Greece
Research Site
Drapetsona, Attikis, Greece
Research Site
Elefsina, Attikis, Greece
Research Site
Glyfada, Attikis, Greece
Research Site
Ilissia, Attikis, Greece
Research Site
Kifisia, Attikis, Greece
Research Site
Koropi, Attikis, Greece
Research Site
Maroussi, Attikis, Greece
Research Site
N. Kosmos, Attikis, Greece
Research Site
Pagrati, Attikis, Greece
Research Site
Petroupoli, Attikis, Greece
Research Site
Piraeus, Attikis, Greece
Research Site
Thiva, Attikis, Greece
Research Site
Vironas, Attikis, Greece
Research Site
Ag. Nikolaos, Crete, Greece
Research Site
Agrinio, Etoloakarnania, Greece
Research Site
Arta, Etoloakarnania, Greece
Research Site
Alexandroupolis, Evros, Greece
Research Site
Lamia, Fhiotidos, Greece
Research Site
Amaliada, Ilias, Greece
Research Site
Karditsa, Karditsas, Greece
Research Site
Katerini, Katerinis, Greece
Research Site
Kavala, Kavalas, Greece
Research Site
Sparti, Lakonias, Greece
Research Site
Edessa, Pellas, Greece
Research Site
Giannitsa, Pellas, Greece
Research Site
Preveza, Prevezis, Greece
Research Site
Thessaloniki, Thessalonikis, Greece
Research Site
Trikala, Trikalon, Greece
Research Site
Serres, Greece
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Dr. Panagiotis Pontikis AstraZeneca S.A. Greece
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01202604     History of Changes
Other Study ID Numbers: NIS-NGR-DUM-2010/1
Study First Received: September 14, 2010
Last Updated: December 19, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by AstraZeneca:
Bipolar disorder I and II
mood event
manic or depressive
Greece

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014