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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge Health Alliance
• Collaborator: AstraZeneca
• Treatments: Quetiapine Fumarate

Criteria

Inclusion Criteria:

• Male and female outpatients, age 18-65.

• Diagnosis of Social Anxiety Disorder (SAD), generalized subtype, by DSM-IV criteria.

• Liebowitz Social Anxiety Scale (LSAS) rating greater than or equal to 50 for both phases.

• Hamilton Depression Scale (HAM-D-17) score less than or equal to 16.

Exclusion Criteria:

• Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months).

• Patients with current or history of bipolar disorder, schizophrenia, or other psychotic conditions.

• Patients with a history of alcohol or substance abuse or dependence within the last six months or a positive toxicology screen consistent with abuse at baseline.

• Patients with significant unstable medical illness, including any medical pathology considered not well-controlled with conventional treatment, i.e., that may require during the study period medication adjustment, ongoing tests or procedures, intensive treatment or hospitalization. In addition, baseline laboratory tests will be conducted and required to be within normal limits or have no clinical significance for patient entry in the study.

• Severe personality disorders likely to interfere with study participation or who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk.

• Ongoing psychotherapy directed toward the treatment of social anxiety disorder.

• History of hypersensitivity to sertraline and quetiapine.