- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01224067
Adjunctive Quetiapine in the Treatment of Refractory Social Anxiety Disorder in Adults
April 17, 2017 updated by: Cambridge Health Alliance
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.
Study Overview
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
Enrollment (Anticipated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Cambridge, Massachusetts, United States, 02139
- Cambridge Health Alliance
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Quetiapine
Quetiapine (dosage 50mg to 300mg + sertraline)Experimental
|
Adjunctive quetiapine -Participant will receive up to 300 mg/day of quetiapine for 8 weeks.
Other Names:
|
Placebo Comparator: Placebo
Participant will receive placebo for 8 weeks.
|
Adjunctive quetiapine -Participant will receive up to 300 mg/day of quetiapine for 8 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from Baseline to Endpoint at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from Baseline to Endpoint at 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gustavo D Kinrys, MD, Cambridge Health Alliance; Harvard Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
September 10, 2010
First Submitted That Met QC Criteria
October 18, 2010
First Posted (Estimate)
October 19, 2010
Study Record Updates
Last Update Posted (Actual)
April 18, 2017
Last Update Submitted That Met QC Criteria
April 17, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHA-IRB-0094/11/04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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