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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202604
• Other study ID #: NIS-NGR-DUM-2010/1
• Status: Completed
• Phase: N/A
• First received: September 14, 2010
• Last updated: December 19, 2011
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 ?, 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder

Locations

Country	Name	City	State
Greece	Research Site	Ag. Nikolaos	Crete
Greece	Research Site	Ag. Paraskevi	Attikis
Greece	Research Site	Agrinio	Etoloakarnania
Greece	Research Site	Aigio	Achaias
Greece	Research Site	Alexandroupolis	Evros
Greece	Research Site	Amaliada	Ilias
Greece	Research Site	Arta	Etoloakarnania
Greece	Research Site	Athens	Attikis
Greece	Research Site	Chaidari	Attikis
Greece	Research Site	Drapetsona	Attikis
Greece	Research Site	Edessa	Pellas
Greece	Research Site	Elefsina	Attikis
Greece	Research Site	Giannitsa	Pellas
Greece	Research Site	Glyfada	Attikis
Greece	Research Site	Ilissia	Attikis
Greece	Research Site	Karditsa	Karditsas
Greece	Research Site	Katerini	Katerinis
Greece	Research Site	Kavala	Kavalas
Greece	Research Site	Kifisia	Attikis
Greece	Research Site	Koropi	Attikis
Greece	Research Site	Lamia	Fhiotidos
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	Preveza	Prevezis
Greece	Research Site	Serres
Greece	Research Site	Sparti	Lakonias
Greece	Research Site	Thessaloniki	Thessalonikis
Greece	Research Site	Thiva	Attikis
Greece	Research Site	Trikala	Trikalon
Greece	Research Site	Vironas	Attikis

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No
Secondary	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)	No
Secondary	YMRS total score, HAM-D total score		At baseline and final visit (9 months after the acute mood episode)	No