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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01224067
Recruitment Status : Completed
First Posted : October 19, 2010
Last Update Posted : April 18, 2017
Information provided by (Responsible Party):
Cambridge Health Alliance

September 10, 2010
October 19, 2010
April 18, 2017
March 2006
July 2008   (Final data collection date for primary outcome measure)
Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Change from Baseline to Endpoint at 8 weeks ]
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.
Same as current
Complete list of historical versions of study NCT01224067 on Archive Site
Clinical Global Impression of Improvement (CGI-I) scores [ Time Frame: Change from Baseline to Endpoint at 8 weeks ]
Change from Baseline to Endpoint after 8 weeks of treatment in overall clinical improvement of social anxiety symptoms.
Same as current
Not Provided
Not Provided
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
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.
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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Social Anxiety Disorder
Drug: Quetiapine
Adjunctive quetiapine -Participant will receive up to 300 mg/day of quetiapine for 8 weeks.
Other Name: Seroquel
  • Active Comparator: Quetiapine
    Quetiapine (dosage 50mg to 300mg + sertraline)Experimental
    Intervention: Drug: Quetiapine
  • Placebo Comparator: Placebo
    Participant will receive placebo for 8 weeks.
    Intervention: Drug: Quetiapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2008
July 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Cambridge Health Alliance
Cambridge Health Alliance
Principal Investigator: Gustavo D Kinrys, MD Cambridge Health Alliance; Harvard Medical School
Cambridge Health Alliance
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP