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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00699985
Other study ID # 132/11872
Secondary ID
Status Completed
Phase N/A
First received June 17, 2008
Last updated August 13, 2010
Start date September 2006
Est. completion date December 2007

Study information

Verified date August 2010
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Observational

Clinical 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 14 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Probable Behcet's Disease

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Iran, Islamic Republic of Rheumatology Research Center, Shariati Hospital Tehran

Sponsors (1)

Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Secondary Total score of SCL90-R dimensions and global indexes 22months No
See also
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Completed NCT00664599 - Rituximab for the Treatment of Severe Ocular Manifestations of Behcet's Disease Phase 2