Clinical trial NCT01202604: A Study Evaluating the Efficacy of Administered Maintenance Treatments in Bipolar Disorder I and II.
Official title: Prospective, Observational Study for the Maintenance Treatment of Patients With Bipolar Disorder I and II in Greece.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Bipolar disorder I and II
mood event
manic or depressive
Greece
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).


Eligibility 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.

Primary outcomes:
measure: The proportion of patients (n, %) who will experience a relapse episode (manic, hypomanic, depressive, mixed)
timeFrame: During the first 9 months after the acute mood episode or in case of relapse occurrence.
Secondary outcomes:
measure: Description of administered treatments for the management of the acute phase of bipolar disorder [mood stabilizers (n,%), antidepressants (n,%), and antipsychotics (n,%)].
timeFrame: 4 months and 9 months after the acute mood episode or in case of relapse occurrence
measure: Description of management of relapse episodes in patients previously receiving treatment during the maintenance phase
timeFrame: In all visits - during the whole study period (9 months)
measure: YMRS total score, HAM-D total score
timeFrame: At baseline and final visit (9 months after the acute mood episode)
Other outcomes:
Locations:
city: Aigio
country: Greece
facility: Research Site
state: Achaias
city: Ag. Paraskevi
country: Greece
facility: Research Site
state: Attikis
city: Athens
country: Greece
facility: Research Site
state: Attikis
city: Chaidari
country: Greece
facility: Research Site
state: Attikis
city: Drapetsona
country: Greece
facility: Research Site
state: Attikis
city: Elefsina
country: Greece
facility: Research Site
state: Attikis
city: Glyfada
country: Greece
facility: Research Site
state: Attikis
city: Ilissia
country: Greece
facility: Research Site
state: Attikis
city: Kifisia
country: Greece
facility: Research Site
state: Attikis
city: Koropi
country: Greece
facility: Research Site
state: Attikis
city: Maroussi
country: Greece
facility: Research Site
state: Attikis
city: N. Kosmos
country: Greece
facility: Research Site
state: Attikis
city: Pagrati
country: Greece
facility: Research Site
state: Attikis
city: Petroupoli
country: Greece
facility: Research Site
state: Attikis
city: Piraeus
country: Greece
facility: Research Site
state: Attikis
city: Thiva
country: Greece
facility: Research Site
state: Attikis
city: Vironas
country: Greece
facility: Research Site
state: Attikis
city: Ag. Nikolaos
country: Greece
facility: Research Site
state: Crete
city: Agrinio
country: Greece
facility: Research Site
state: Etoloakarnania
city: Arta
country: Greece
facility: Research Site
state: Etoloakarnania
city: Alexandroupolis
country: Greece
facility: Research Site
state: Evros
city: Lamia
country: Greece
facility: Research Site
state: Fhiotidos
city: Amaliada
country: Greece
facility: Research Site
state: Ilias
city: Karditsa
country: Greece
facility: Research Site
state: Karditsas
city: Katerini
country: Greece
facility: Research Site
state: Katerinis
city: Kavala
country: Greece
facility: Research Site
state: Kavalas
city: Sparti
country: Greece
facility: Research Site
state: Lakonias
city: Edessa
country: Greece
facility: Research Site
state: Pellas
city: Giannitsa
country: Greece
facility: Research Site
state: Pellas
city: Preveza
country: Greece
facility: Research Site
state: Prevezis
city: Thessaloniki
country: Greece
facility: Research Site
state: Thessalonikis
city: Trikala
country: Greece
facility: Research Site
state: Trikalon
city: Serres
country: Greece
facility: Research Site
Study officials:
affiliation: AstraZeneca S.A. Greece
name: Dr. Panagiotis Pontikis
role: STUDY_DIRECTOR
References: