NCT01224067

Adjunctive Quetiapine in the Treatment of Refractory Social Anxiety Disorder in Adults

A Double-Blind, Placebo-Controlled, Flexible-Dosage Study to Evaluate the Efficacy and Safety of Adjunctive Quetiapine in the Treatment of Refractory Social Anxiety Disorder in Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cambridge Health Alliance · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a 16-week research study in which participants suffering from Social Anxiety Disorder (SAD) will receive Sertraline (a medication FDA approved for the treatment of SAD) for the first 8 weeks. If a participant remains symptomatic, he/she will enter the second phase of the study in which he/she continues taking Sertraline but also randomly receives either Seroquel or placebo in conjunction with Sertraline for additional 8 weeks. The purpose of this study is to determine the efficacy of adjunctive Seroquel in treating SAD.

Detailed description

This will be a single-site study aimed at evaluating the safety, tolerability, and efficacy of quetiapine as compared to placebo in the treatment of generalized anxiety disorder. This will be an 8-week open-label sertraline trial followed by a randomized double-blind placebo-controlled, parallel-group prospective study. Participants will first receive sertraline (25-200 mg/day) for 8 weeks. Patients who remain symptomatic - are considered refractory - and meet inclusion criteria will be randomized and enter the double-blind phase. They will receive either adjunctive quetiapine (25-400 mg/day) or placebo for 8 weeks. The primary outcome measures are change in the Liebowitz Social Anxiety Scale(LSAS) and Clinical Global Impression of Improvement (CGI-I) scores. The proposed sample size is 80 subjects. Patients will be discontinued from the study if needed due to ineffectiveness or excessive side effects. Measurements of changes in efficacy and side effects will be carried out every weekly visit. Enrollment will occur over 12 months.

Conditions

• Social Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Quetiapine	Adjunctive quetiapine -Participant will receive up to 300 mg/day of quetiapine for 8 weeks.

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-07-01
• Completion: 2008-10-01
• First posted: 2010-10-19
• Last updated: 2017-04-18

Locations

1 site across 1 country: United States