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

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00691353
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-04
• Study First Posted: 2008-06-05
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-02
• Last Update Posted: 2008-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
Assessment of functioning - Relative score reported in GAF scale	2 - 4 months after the initiation of the therapy. No baseline comparison

Secondary Outcome Measures

Name	Time	Method
To depict sociodemographic characteristics and comorbidities.	Reported at the site visit

Trial Locations

Locations (1)

Research Site; 🇬🇷 Thiva, Greece