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

• ClinicalTrials.gov Identifier: NCT01224067
• Recruitment Status: Completed
• First Posted: October 19, 2010
• Last Update Posted: April 18, 2017
• Sponsor: Cambridge Health Alliance
• Collaborator: AstraZeneca
• Information provided by (Responsible Party): Cambridge Health Alliance

Tracking Information

• First Submitted Date: September 10, 2010
• First Posted Date: October 19, 2010
• Last Update Posted Date: April 18, 2017
• Study Start Date: March 2006
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT01224067 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Adjunctive Quetiapine in the Treatment of Refractory Social Anxiety Disorder in Adults
• 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Social Anxiety Disorder

Intervention

Drug: Quetiapine

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

Other Name: Seroquel

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: October 18, 2010): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2008
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01224067
• Other Study ID Numbers: CHA-IRB-0094/11/04
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Cambridge Health Alliance
• Study Sponsor: Cambridge Health Alliance
• Collaborators: AstraZeneca

Investigators

• Principal Investigator: Gustavo D Kinrys, MD; Cambridge Health Alliance; Harvard Medical School

• PRS Account: Cambridge Health Alliance
• Verification Date: April 2017