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

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.

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Key information

Conditions

Bipolar Disorder Behavior Bipolar and Related Disorders Mental Disorders Mood Disorders Social Adjustment Social Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Agrinio, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: DIDAXI

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Jun 5, 2008
Registry last updated: Dec 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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