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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04977544
Other study ID # 2019232
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date September 1, 2022

Study information

Verified date June 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact zheng lin, doctor
Phone 13606509130
Email linzzr@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To explore the efficacy of drugs combined with virtual reality exposure therapy in the treatment of phobias compared with single drug treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Meet the diagnostic criteria for phobias in DSM-IV. - Age from 18 to 45 years old. - Graduated from junior high school or above. - No serious physical disease, no serious visual impairment, and no family history of mental illness. Exclusion Criteria: - Exclude other psychiatric diagnosis and treatment history.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
vert
On the basis of sertraline drug treatment, phobia patients were given 2d/times from the 5th week, each 35-45min VR exposure treatment, 15 times as a course of treatment.
Drug:
Sertraline
Sertraline was given as a single drug, with an initial dose of 50 mg/d, and gradually increased to the maximum dose of 200 mg/d after 2 weeks. The treating physician will determine the specific dose adjustment according to the patient's condition.

Locations

Country Name City State
China The Fourth Affiliated Hospital of Zhejiang University Medical College Yiwu Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the level of anxiety the score of Hamilton anxiety scale, the minimum and maximum values are 0 and 56, and higher scores mean a worse outcome. 3 months
Primary heart rate of the patients take the heart rate as a biomarker of fear, the faster heart rate means the participate is more afraid 3 months
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