Bipolar DisorderNCT00660712
Evaluation of Patient Characteristics and Treatment Approaches to Patients With Bipolar Disorder in Turkey
An observational study of Bipolar Disorder, run by AstraZeneca at 19 sites in Turkey (Türkiye).
Trial summary
A registry study to identify the patient-diagnosis-treatment characteristic profile of patients with bipolar disorder in Turkey. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- How many people
- 1,018 participants
- Where
- 19 sitesTurkey (Türkiye)
- Study dates
- Mar 2008to Mar 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Speciality care outpatient clinic (Psychiatry outpatient clinic)
Who may be able to join
- Patients previously or currently diagnosed with bipolar disorder
- Patients (or any of their relatives) who give a written informed consent.
Who cannot join
- Patients who were previously included in this study.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Turkey (Türkiye)19 sites
Research Site
Adana
Research Site
Afyonkarahisar
Research Site
Ankara
Research Site
Antalya
Research Site
Aydin
Research Site
Batman
Research Site
Denizli
Research Site
Erzincan
Research Site
Eskişehir
Research Site
Istanbul
Research Site
Izmir
Research Site
Konya
Research Site
Malatya
Research Site
Mardin
Research Site
Mersin
Research Site
Rize
Research Site
Samsun
Research Site
Sivas
Research Site
Trabzon
About this study
A registry study to identify the patient-diagnosis-treatment characteristic profile of patients with bipolar disorder in Turkey.
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder, patient characteristics, treatment characteristics
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with bipolar disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the patient-diagnosis-treatment characteristic profile of patients with bipolar disorder in Turkey.
Secondary outcomes (5)
Evaluation of the time period that elapsed since the diagnosis of bipolar disorder
Evaluation of co-morbid psychiatric diseases
Identification of treatment modalities selected according to the disease phase
Identification of the number of first degree relatives diagnosed with bipolar disorder
Evaluation of the relationship between patient and disease characteristics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startMar 2008
- Study completionMar 2009
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,018 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mustafa Bilici, MD, Assoc. Prof, Study director, Erenkoy State Hospital for Psychiatric Diseases, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660712
- Sponsor's protocol ID
- NIS-NTR-DUM-2007/1
- Status last verified
- May 2009
- First submitted
- 15 Apr 2008
- Last updated
- 25 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Characteristics and Treatment Approaches to Patients With Bipolar Disorder in Turkey
- ClinicalTrials.gov ID
- NCT00660712
- Acronym / sponsor ID
- NIS-NTR-DUM-2007/1
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder, patient characteristics, treatment characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,018 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Apr 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.
A registry study to identify the patient-diagnosis-treatment characteristic profile of patients with bipolar disorder in Turkey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with bipolar disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Speciality care outpatient clinic (Psychiatry outpatient clinic)
Key inclusion criteria (2 listed)
- Patients previously or currently diagnosed with bipolar disorder
- Patients (or any of their relatives) who give a written informed consent.
Key exclusion criteria (1 listed)
- Patients who were previously included in this study.
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
Identification of the patient-diagnosis-treatment characteristic profile of patients with bipolar disorder in Turkey.
5 secondary outcomes
Evaluation of the time period that elapsed since the diagnosis of bipolar disorder
Evaluation of co-morbid psychiatric diseases
Identification of treatment modalities selected according to the disease phase
Identification of the number of first degree relatives diagnosed with bipolar disorder
Evaluation of the relationship between patient and disease characteristics
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 25 May 2009.
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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.
Mustafa Bilici, MD, Assoc. Prof study director
Erenkoy State Hospital for Psychiatric Diseases, Istanbul, Turkey
19 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 19 sites in Turkey (Türkiye).
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 2 inclusion and 1 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 25 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Turkey (Türkiye). 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?
Identification of the patient-diagnosis-treatment characteristic profile of patients with bipolar disorder in Turkey.. 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 25 May 2009.