Adjunctive Quetiapine in the Treatment of Refractory Social Anxiety Disorder in Adults
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ClinicalTrials.gov Identifier: NCT01224067 |
Recruitment Status :
Completed
First Posted : October 19, 2010
Last Update Posted : April 18, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Social Anxiety Disorder | Drug: Quetiapine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, 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 |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | July 2008 |
Actual Study Completion Date : | October 2008 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Quetiapine
Quetiapine (dosage 50mg to 300mg + sertraline)Experimental
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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 |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224067
United States, Massachusetts | |
Cambridge Health Alliance | |
Cambridge, Massachusetts, United States, 02139 |
Principal Investigator: | Gustavo D Kinrys, MD | Cambridge Health Alliance; Harvard Medical School |
Responsible Party: | Cambridge Health Alliance |
ClinicalTrials.gov Identifier: | NCT01224067 History of Changes |
Other Study ID Numbers: |
CHA-IRB-0094/11/04 |
First Posted: | October 19, 2010 Key Record Dates |
Last Update Posted: | April 18, 2017 |
Last Verified: | April 2017 |
Quetiapine Fumarate Anxiety Disorders Phobia, Social Mental Disorders Phobic Disorders Antidepressive Agents |
Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |