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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00691353

Purpose

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.

Condition
Bipolar Disorder

MedlinePlus related topics: Bipolar Disorder

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Cross-Sectional
Official Title:	Subjective Well Being of Patients Receiving Atypical Antipsychotics as Monotherapy or Cotherapy With Mood Stabilizers

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	540
Study Start Date:	April 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Target Group:Patients that suffer from Bipolar Disorder Type 1 who are treated with atypical antipsychotics as monotherapy or cotherapy with mood stabilizers

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691353

Locations

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
THIVA, 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
LAMIA, Greece

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Charalambos Touloumis, MD

Athens Psychiatric Hospital Greece

More Information

Responsible Party:	AstraZeneca, SA Greece ( Dr Pontikis Panagiotis, MD Medical and Regulatory Affairs Director )
Study ID Numbers:	NIS-NGR-DUM-2008/1
Study First Received:	June 3, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00691353
Health Authority:	Greece: National Organization of Medicines

Keywords provided by AstraZeneca:

Bipolar Disorder
antipsychotics
social functioning
mood stabilizers
Bipolar Disorder Type I

atypical antipsychotics
monotherapy
cotherapy
mood stabilizers

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders

ClinicalTrials.gov processed this record on January 15, 2009