Do patients with social anxiety disorder who receive psychotherapy have any benefits if additional treatment with an antidepressant is added?

Not Applicable

Completed

• Conditions: Social anxiety disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN57551461
• Lead Sponsor: FAPESP - Fundação de Amparo à Pesquisa do Estado de São Paulo

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30372482 results 2018 Protocol article in https://doi.org/10.1371/journal.pone.0205809.s003 (added 17/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-11-30
• Study Start: 2018-02-02
• Last Update Posted: 27 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

1. Recruitment occurred at the Anxiety Disorders Program of the Institute of Psychiatry, Sao Paulo University Medical School
2. Participants aged from 18 to 65 years were interviewed first by a clinical psychologists using a protocol specific interview and then by a psychiatrist using the Structured Clinical Interview for DSM-IV
3. Social anxiety disorder had to be the primary diagnosis, with or without comorbid depression
4. Symptom duration had to exceed 1 year

Exclusion Criteria

1. Clinically significant suicidal risk
2. Beck Depression Inventory score greater than or equal to 30
3. Hamilton Depression Rating Scale score greater than or equal to 21
4. Any other primary psychiatric DSM-IV diagnosis
5. Any medical-systemic disease possibly affecting mental condition including epilepsy
6. Intake of more than two units of alcohol/day
7. Current use of antidepressant medications or benzodiazepines

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Treatment global clinical response, measured as a score of 1 (very much improved) or 2 (much improved) on the Clinical Global Impression-Improvement scale at week 20<br> 2. Core social symptoms measured using the Scale of Avoidance and Social Discomfort (SASD) at week 20<br> 3. Social skills acquisition, time-by-treatment interaction of the SASD score (week 0 vs week 20) and Multidimensional Scale of Social Expression – Motor Part (M-MSSE) score (week 0 vs week 20)<br>