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.
1 other identifier
observational
294
1 country
33
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 14, 2010
CompletedFirst Posted
Study publicly available on registry
September 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedDecember 20, 2011
December 1, 2011
1.2 years
September 14, 2010
December 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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)
Study Arms (1)
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 Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (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
Research Site
Marousi, Attikis, Greece
Research Site
N. Kosmos, Attikis, Greece
Research Site
Pangrati, Attikis, Greece
Research Site
Petroúpolis, Attikis, Greece
Research Site
Piraeus, Attikis, Greece
Research Site
Thebes, 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
Alexandroupoli, Evros, Greece
Research Site
Lamia, Fhiotidos, Greece
Research Site
Amaliáda, 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
Giannitsá, Pellas, Greece
Research Site
Preveza, Prevezis, Greece
Research Site
Serres, Serres, Greece
Research Site
Thessaloniki, Thessalonikis, Greece
Research Site
Trikala, Trikalon, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. Panagiotis Pontikis
AstraZeneca S.A. Greece
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2010
First Posted
September 16, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
December 20, 2011
Record last verified: 2011-12