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

N/ACompletedNCT00691353
AstraZeneca540 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

540

Conditions

Bipolar Disorder

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years
Medical Language ↔ Plain English
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.

Locations (20)

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

...and 10 more locations

Outcomes

Primary Outcomes

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 Outcomes

To depict sociodemographic characteristics and comorbidities.

Time frame: Reported at the site visit

Data from ClinicalTrials.gov

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