Subjective Well Being of Patients Receiving Atypical Antipsychotics as Monotherapy or Cotherapy With Mood Stabilizers (DIDAXI)
This study has been completed.
Information provided by:
First received: June 3, 2008
Last updated: December 2, 2008
Last verified: December 2008
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Subjective Well Being of Patients Receiving Atypical Antipsychotics as Monotherapy or Cotherapy With Mood Stabilizers|
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Difference in the scores reported in YMRS and Hamilton - D scales from baseline(start of therapy) [ Time Frame: 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 [ Time Frame: 2 - 4 months after the initiation of the therapy. No baseline comparison ]
Secondary Outcome Measures:
- To depict sociodemographic characteristics and comorbidities. [ Time Frame: Reported at the site visit ]
|Study Start Date:||April 2008|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691353
Sponsors and Collaborators
|Principal Investigator:||Charalambos Touloumis, MD||Athens Psychiatric Hospital Greece|