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

NCT01224067 | Completed Phase 4

• 1 other identifier: CHA-IRB-0094/11/04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Liebowitz Social Anxiety Scale (LSAS)

  Change from Baseline to Endpoint of social anxiety symptoms after 8 weeks of treatment. Assessed weekly throughout the study for a total of 8 weeks.

  Change from Baseline to Endpoint at 8 weeks

Secondary Outcomes (1)

• Clinical Global Impression of Improvement (CGI-I) scores

  Change from Baseline to Endpoint at 8 weeks

Study Arms (2)

Quetiapine

ACTIVE COMPARATOR

Quetiapine (dosage 50mg to 300mg + sertraline)Experimental

Drug: Quetiapine

Placebo

PLACEBO COMPARATOR

Participant will receive placebo for 8 weeks.

Drug: Quetiapine

Interventions

Quetiapine DRUG

Adjunctive quetiapine -Participant will receive up to 300 mg/day of quetiapine for 8 weeks.

Also known as: Seroquel

Placebo; Quetiapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• AstraZeneca: collaborator

Study Sites (1)

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gustavo D Kinrys, MD

  Cambridge Health Alliance; Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: October 19, 2010
• Study Start: March 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

US (1)