Clinical Study of PET/CT and Association With Metabolic Syndrome/Depressive Symptoms in Psoriasis

Depression Clinical Trial

Official title:

Phase 0 Clinical Study of PET/CT and Association With Metabolic Syndrome/Depressive Symptoms in Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01661127
• Other study ID #: PNUHDM-psoriasis
• Status: Recruiting
• Phase: N/A
• First received: August 7, 2012
• Last updated: November 3, 2014
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: November 2014
• Source: Pusan National University Hospital
• Contact: Byung-Soo Kim, Ph D.
• Phone: 82-51-240-7338
• Email: dockbs[@]pusan.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Psoriasis is associated with increases in markers of inflammation in the skin and blood and increasingly is thought to be a systemic inflammatory disease and risk factor for incident diabetes mellitus, myocardial infarction, stroke, and premature cardiovascular death. Furthermore, it is important for clinicians to be aware that psoriasis can have a substantial emotional impact on an individual, which is not necessarily related to the extent of skin disease.

FDG-PET/CT represents an innovative approach to studying systemic inflammation in a manner that is sensitive, quantifiable, and anatomically localizable. Also, recent study show that chronic disease such as end stage renal disease with depressive symptoms have decreased cerebral glucose metabolism in several brain areas in F-18-FDG PET/CT. So this protocol was designed to evaluate usefulness of PET/CT to detect systemic inflammation and abnormality of cerebral glucose metabolism and association with metabolic syndrome/major depressive symptoms in patients with psoriasis.

Description:

10 Patients with psoriasis

1. Evaluate PASI score

2. Evaluate comorbidity with metabolic syndrome

• Body mass index(BMI)

• Checking blood pressure

• Checking blood sugar

• Smoking and drinking history

• Checking blood cholesterol level

• Risk factors of cardiovascular disease

3. PET/CT for measuring the extent and site of psoriasis with inflammation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histological diagnosis of plaque type psoriasis

• at least 18 years old

Exclusion Criteria:

• those who cannot understand questionnaire

• those who take antidepressant

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Metabolic Syndrome
• Metabolic Syndrome X
• Psoriasis
• Syndrome

Locations

Country	Name	City	State
Korea, Republic of	Department of dermatology, Pusan National University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck depression inventory scoring and Korean Hamilton depression scale scoring		Day 0 and 28 weeks later	Yes
Secondary	Brain glucose uptake using PET/CT		Day 0 and 28 weeks later	Yes