Subjective Well Being of Patients Receiving Atypical Antipsychotics as Monotherapy or Cotherapy With Mood Stabilizers

Bipolar Disorder Clinical Trial

— DIDAXI  

Official title:

Subjective Well Being of Patients Receiving Atypical Antipsychotics as Monotherapy or Cotherapy With Mood Stabilizers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691353
• Other study ID #: NIS-NGR-DUM-2008/1
• Status: Completed
• Phase: N/A
• First received: June 3, 2008
• Last updated: December 2, 2008
• Start date: April 2008
• Est. completion date: July 2008

Study information

• Verified date: December 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial Summary

Cross - Sectional study requiring one visit at the investigators office for the data collection.

• Target Group: Patients that suffer from Bipolar Disorder Type 1.

• YMRS - HAMILTON and GAF scales are going to be used to assess the clinical outcome. The findings are going to be based on the different scores reported by Specialists (before the patients started to use as a therapy atypical antipsychotics / at the time that the visit actually takes place for the cause of the study.) We predefine the time period that the patient should be using atypical antipsychotics at minimum (2 months).

• The first 9 consecutive patients that visit the Specialist and meet the entry criteria and signs the ICF will be recruited in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients that are diagnosed with Bipolar Disorder Type 1 according to diagnostic criteria DSM - IV

• Patients that have started therapy with atypical antipsychotics as monotherapy or cotherapy with mood stabilizers the last three months, but have completed 2 full months of therapy.

• Patients with anxiety disorder can be recruited in the study unless it is dominant.

Exclusion Criteria:

• Patients that use antidepressant medication

• Patients who were treated with depot antipsychotic in the last quarter before their enrollment in the study.

• Patients who are addicts of toxic substances.

• Patients who suffer from other serious diseases.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bipolar Disorder

Locations

Country	Name	City	State
Greece	Research Site	Agrinio
Greece	Research Site	Alexandroupoli
Greece	Research Site	Athens
Greece	Research Site	Crete
Greece	Research Site	Elefsina
Greece	Research Site	Ioannina
Greece	Research Site	Karditsa
Greece	Research Site	Katerini
Greece	Research Site	KOS
Greece	Research Site	Kozani
Greece	Research Site	Lamia
Greece	Research Site	Larisa
Greece	Research Site	Nafplio
Greece	Research Site	Patra
Greece	Research Site	Peiraias
Greece	Research Site	Rodos
Greece	Research Site	Serres
Greece	Research Site	Thessalonii
Greece	Research Site	Thessaloniki
Greece	Research Site	Thiva

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the scores reported in YMRS and Hamilton - D scales from baseline(start of therapy)		Assessment of the progress of disease 2 to 4 months after the initiation of the therapy(baseline)
Primary	Assessment of functioning - Relative score reported in GAF scale		2 - 4 months after the initiation of the therapy. No baseline comparison
Secondary	To depict sociodemographic characteristics and comorbidities.		Reported at the site visit