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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Cambridge Health Alliance.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT01224067
First received: September 10, 2010
Last updated: October 18, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Social Anxiety Disorder
 Drug: Quetiapine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Cambridge Health Alliance:

Primary Outcome Measures:
  • Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Change from Baseline to Endpoint at 8 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Clinical Global Impression of Improvement (CGI-I) scores [ Time Frame: Change from Baseline to Endpoint at 8 weeks ] [ Designated as safety issue: No ]
    Change from Baseline to Endpoint after 8 weeks of treatment in overall clinical improvement of social anxiety symptoms.


Estimated Enrollment: 40
Study Start Date: March 2006
Estimated Study Completion Date: November 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Quetiapine
Quetiapine (dosage 50mg to 300mg + sertraline)Experimental
 Drug: Quetiapine
Adjunctive quetiapine -Participant will receive up to 300 mg/day of quetiapine for 8 weeks.
Other Name: Seroquel
Placebo Comparator: Placebo
Participant will receive placebo for 8 weeks.
 Drug: Quetiapine
Adjunctive quetiapine -Participant will receive up to 300 mg/day of quetiapine for 8 weeks.
Other Name: Seroquel

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224067

Locations
United States, Massachusetts
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Cambridge Health Alliance
AstraZeneca
Investigators
Principal Investigator: Gustavo D Kinrys, MD Cambridge Health Alliance; Harvard Medical School
  More Information

No publications provided

Responsible Party: Gustavo Kinrys, MD, Cambridge Health Alliance; Harvard Medical School
ClinicalTrials.gov Identifier: NCT01224067     History of Changes
Other Study ID Numbers: CHA-IRB-0094/11/04
Study First Received: September 10, 2010
Last Updated: October 18, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 21, 2013