Bipolar DisorderDIDAXINCT00691353
Subjective Well Being of Patients Receiving Atypical Antipsychotics as Monotherapy or Cotherapy With Mood Stabilizers
An observational study of Bipolar Disorder, run by AstraZeneca at 20 sites in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- How many people
- 540 participants
- Where
- 20 sitesGreece
- Study dates
- Apr 2008to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Greece20 sites
Research Site
Agrinio
Research Site
Alexandroupoli
Research Site
Athens
Research Site
Crete
Research Site
Elefsina
Research Site
Ioannina
Research Site
Karditsa
Research Site
Katerini
Research Site
Kos
Research Site
Kozani
Research Site
Lamia
Research Site
Larissa
Research Site
Nafplion
Research Site
Pátrai
Research Site
Piraeus
Research Site
Rhodes
Research Site
Serres
Research Site
Thebes
Research Site
Thessalonii
Research Site
Thessaloniki
About this study
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.
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, antipsychotics, social functioning, mood stabilizers, Bipolar Disorder Type I, atypical antipsychotics, monotherapy, cotherapy
- Medical subject headings
- Bipolar Disorder, Social Adjustment
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the scores reported in YMRS and Hamilton - D scales from baseline(start of therapy)
Measured: 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
Measured: 2 - 4 months after the initiation of the therapy. No baseline comparison
Secondary outcomes (1)
To depict sociodemographic characteristics and comorbidities.
Measured: Reported at the site visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Charalambos Touloumis, MD, Principal investigator, Athens Psychiatric Hospital Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691353
- Sponsor's protocol ID
- NIS-NGR-DUM-2008/1
- Acronym
- DIDAXI
- Status last verified
- Dec 2008
- First submitted
- 3 Jun 2008
- Last updated
- 3 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective Well Being of Patients Receiving Atypical Antipsychotics as Monotherapy or Cotherapy With Mood Stabilizers
- ClinicalTrials.gov ID
- NCT00691353
- Acronym / sponsor ID
- DIDAXI / NIS-NGR-DUM-2008/1
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, antipsychotics, social functioning, mood stabilizers, Bipolar Disorder Type I, atypical antipsychotics, monotherapy, cotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
To depict sociodemographic characteristics and comorbidities.
Time frame: Reported at the site visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charalambos Touloumis, MD principal investigator
Athens Psychiatric Hospital Greece
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by AstraZeneca at 20 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2008.