Behcet's SyndromeSCL90-RNCT00699985
Psychological Symptoms in Patients With Behcet's Disease by SCL90-R
An observational study of Behcet's Syndrome, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
To find the overall psychological profile of patients with Behcet's Disease (BD) and compare it with Non-BD patients.patients were checked for psychological symptoms by Symptom Check List 90 Revised (SCL90-R) Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Behcet's Syndrome
- How many people
- 400 participants
- Where
- 1 siteIran
- Study dates
- Sep 2006to Dec 2007
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: BD and Non-BD patients who attended the clinic for their routine follow-up.
Who may be able to join
- Behcet's disease patients that their diagnosis was based on the new International Criteria for Behcet's Disease (ICBD).
- Non-Behcet's disease patients were patients mimicking BD.
Who cannot join
- Probable Behcet's Disease
Trial locations and contacts
1 site in 1 country.
Iran1 site
Rheumatology Research Center, Shariati Hospital
Tehran, Tehran Province, 14114
About this study
Official title: Comparison of Psychological Symptoms in Patients With Behcet's Disease and Control Patients by Symptom Check List 90-Revised (SCL-90-R)
To find the overall psychological profile of patients with Behcet's Disease (BD) and compare it with Non-BD patients.patients were checked for psychological symptoms by Symptom Check List 90 Revised (SCL90-R)
Read the detailed description
200 BD and 200 Non-BD patients were checked for psychological symptoms by Symptom Check List 90 Revised (SCL90-R). BD diagnosis was based on the new International Criteria for Behcet's Disease (ICBD). Non-BD patients were patients mimicking BD. All patients were asked to complete the SCL90-R when they attended the clinic for their routine follow-up. The demographic information and disease manifestations including ocular and neurological involvement were registered. For those with visual impairment, SCL90-R was applied by an interviewer. Frequencies and descriptive analysis were measured in both BD and Non-BD groups. Means and standard deviations (SD) of visual acuity were calculated. Data collected from SCL90-R did not have normal distribution in any dimension. The mean values of raw numbers, global severity index (GSI), the positive symptoms total (PST) and the positive symptom distress index (PSDI), were compared by Mann-Whitney U (M-W U) test.).To detect any bias in results due to data collection method, self reported data and reviewer collected data were compared.
- Conditions
- Behcet's Syndrome
- Keywords
- Psychological Symptoms, Behcet's Disease
- Medical subject headings
- Behcet Syndrome
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 | Behcet's Disease patients that their diagnosis was based on the new International Criteria for Behcet's Disease (ICBD). | |
| 2 | Non-Behcet's Disease patients were patients mimicking BD. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startSep 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet's SyndromeStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Bahar Sadeghi, MD, Study director, Rheumatology Research Center, Tehran University for Medical SciencesFereydoun Davatchi, MD, Principal investigator, Rheumatology Research Center, Tehran University for Medical SciencesMaryam Noroozian, MD, Principal investigator, Memory and Behavioral Department, Roozbeh Hospital, Tehran University for Medical SciencesFarhad Shahram, MD, Principal investigator, Rheumatology Research Center, Tehran University for Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699985
- Sponsor's protocol ID
- 132/11872
- Acronym
- SCL90-R
- Status last verified
- Aug 2010
- First submitted
- 17 Jun 2008
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Psychological Symptoms in Patients With Behcet's Disease and Control Patients by Symptom Check List 90-Revised (SCL-90-R)
- ClinicalTrials.gov ID
- NCT00699985
- Acronym / sponsor ID
- SCL90-R / 132/11872
- Conditions
- Behcet's Syndrome
- Keywords
- Psychological Symptoms, Behcet's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Dec 2007 (actual)
- First posted
- 18 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.
To find the overall psychological profile of patients with Behcet's Disease (BD) and compare it with Non-BD patients.patients were checked for psychological symptoms by Symptom Check List 90 Revised (SCL90-R)
Detailed description
200 BD and 200 Non-BD patients were checked for psychological symptoms by Symptom Check List 90 Revised (SCL90-R). BD diagnosis was based on the new International Criteria for Behcet's Disease (ICBD). Non-BD patients were patients mimicking BD. All patients were asked to complete the SCL90-R when they attended the clinic for their routine follow-up. The demographic information and disease manifestations including ocular and neurological involvement were registered. For those with visual impairment, SCL90-R was applied by an interviewer. Frequencies and descriptive analysis were measured in both BD and Non-BD groups. Means and standard deviations (SD) of visual acuity were calculated. Data collected from SCL90-R did not have normal distribution in any dimension. The mean values of raw numbers, global severity index (GSI), the positive symptoms total (PST) and the positive symptom distress index (PSDI), were compared by Mann-Whitney U (M-W U) test.).To detect any bias in results due to data collection method, self reported data and reviewer collected data were compared.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Behcet's Disease patients that their diagnosis was based on the new International Criteria for Behcet's Disease (ICBD). |
| 2 | – | –Non-Behcet's Disease patients were patients mimicking BD. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- BD and Non-BD patients who attended the clinic for their routine follow-up.
Key inclusion criteria (2 listed)
- Behcet's disease patients that their diagnosis was based on the new International Criteria for Behcet's Disease (ICBD).
- Non-Behcet's disease patients were patients mimicking BD.
Key exclusion criteria (1 listed)
- Probable Behcet's Disease
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
Not reported in the source record.
1 secondary outcome
Total score of SCL90-R dimensions and global indexes
Time frame: 22months
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 16 Aug 2010.
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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.
Bahar Sadeghi, MD study director
Rheumatology Research Center, Tehran University for Medical Sciences
Fereydoun Davatchi, MD principal investigator
Rheumatology Research Center, Tehran University for Medical Sciences
Maryam Noroozian, MD principal investigator
Memory and Behavioral Department, Roozbeh Hospital, Tehran University for Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behcet's Syndrome, run by Tehran University of Medical Sciences at 1 site in Iran.
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 16 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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.
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 16 Aug 2010.