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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

Tracking Information
First Submitted Date  ICMJE September 10, 2010
First Posted Date  ICMJE October 19, 2010
Last Update Posted Date April 18, 2017
Study Start Date  ICMJE March 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2010)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Adjunctive Quetiapine in the Treatment of Refractory Social Anxiety Disorder in Adults
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Social Anxiety Disorder
Intervention  ICMJE Drug: Quetiapine
Adjunctive quetiapine -Participant will receive up to 300 mg/day of quetiapine for 8 weeks.
Other Name: Seroquel
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 18, 2010)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01224067
Other Study ID Numbers  ICMJE CHA-IRB-0094/11/04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cambridge Health Alliance
Study Sponsor  ICMJE Cambridge Health Alliance
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Gustavo D Kinrys, MD Cambridge Health Alliance; Harvard Medical School
PRS Account Cambridge Health Alliance
Verification Date April 2017

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