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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00691353
First Posted: June 5, 2008
Last Update Posted: December 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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

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

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Lamia, 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
Thiva, Greece
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Charalambos Touloumis, MD Athens Psychiatric Hospital Greece
  More Information

Responsible Party: Dr Pontikis Panagiotis, MD Medical and Regulatory Affairs Director, AstraZeneca, SA Greece
ClinicalTrials.gov Identifier: NCT00691353     History of Changes
Other Study ID Numbers: NIS-NGR-DUM-2008/1
First Submitted: June 3, 2008
First Posted: June 5, 2008
Last Update Posted: December 3, 2008
Last Verified: December 2008

Keywords provided by AstraZeneca:
Bipolar Disorder
antipsychotics
social functioning
mood stabilizers
Bipolar Disorder Type I
atypical antipsychotics
monotherapy
cotherapy

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs