Clinical trial NCT00691353: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
antipsychotics
social functioning
mood stabilizers
Bipolar Disorder Type I
atypical antipsychotics
monotherapy
cotherapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

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.


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.

Primary outcomes:
measure: Difference in the scores reported in YMRS and Hamilton - D scales from baseline(start of therapy)
timeFrame: Assessment of the progress of disease 2 to 4 months after the initiation of the therapy(baseline)
measure: Assessment of functioning - Relative score reported in GAF scale
timeFrame: 2 - 4 months after the initiation of the therapy. No baseline comparison
Secondary outcomes:
measure: To depict sociodemographic characteristics and comorbidities.
timeFrame: Reported at the site visit
Other outcomes:
Locations:
city: Agrinio
country: Greece
facility: Research Site
city: Alexandroupoli
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Crete
country: Greece
facility: Research Site
city: Elefsina
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Karditsa
country: Greece
facility: Research Site
city: Katerini
country: Greece
facility: Research Site
city: KOS
country: Greece
facility: Research Site
city: Kozani
country: Greece
facility: Research Site
city: Lamia
country: Greece
facility: Research Site
city: Larisa
country: Greece
facility: Research Site
city: Nafplio
country: Greece
facility: Research Site
city: Patra
country: Greece
facility: Research Site
city: Peiraias
country: Greece
facility: Research Site
city: Rodos
country: Greece
facility: Research Site
city: Serres
country: Greece
facility: Research Site
city: Thessalonii
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thiva
country: Greece
facility: Research Site
Study officials:
affiliation: Athens Psychiatric Hospital Greece
name: Charalambos Touloumis, MD
role: PRINCIPAL_INVESTIGATOR
References: