Subjective Well Being of Patients Receiving Atypical Antipsychotics as Monotherapy or Cotherapy With Mood Stabilizers (DIDAXI)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00691353
First received: June 3, 2008
Last updated: December 2, 2008
Last verified: December 2008
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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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691353
Locations
| Greece | |
| Research Site | |
| Agrinio, Greece | |
| Research Site | |
| Alexandroupoli, Greece | |
| Research Site | |
| Athens, Greece | |
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| Crete, Greece | |
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| Elefsina, Greece | |
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| 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 | |
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| 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
No publications provided
| 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 |
| Study First Received: | June 3, 2008 |
| Last Updated: | December 2, 2008 |
| Health Authority: | Greece: National Organization of Medicines |
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 Affective Disorders, Psychotic Mood Disorders Mental Disorders Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 19, 2013