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

AstraZeneca

Status: Completed

Conditions: Bipolar Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT00691353

NIS-NGR-DUM-2008/1

Details and patient eligibility

About

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.

Enrollment: 540 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.