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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 3, 2008

Last Updated Date

December 2, 2008

Start Date ^†

April 2008

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00691353 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

To depict sociodemographic characteristics and comorbidities. [ Time Frame: Reported at the site visit ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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

Study Phase

Study Type ^†

Observational

Study Design ^†

Case-Only, Cross-Sectional

Condition ^†

Bipolar Disorder

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Estimated Enrollment ^†

540

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Greece

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00691353

Responsible Party

Dr Pontikis Panagiotis, MD Medical and Regulatory Affairs Director, AstraZeneca, SA Greece

Secondary IDs ^††

Study Sponsor ^†

AstraZeneca

Collaborators ^††

Investigators ^†

Principal Investigator:

Charalambos Touloumis, MD

Athens Psychiatric Hospital Greece

Information Provided By

AstraZeneca

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.