Status:
COMPLETED
Adjunctive Quetiapine in the Treatment of Refractory Social Anxiety Disorder in Adults
Lead Sponsor:
Cambridge Health Alliance
Collaborating Sponsors:
AstraZeneca
Conditions:
Social Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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. ...
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-wee...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01224067
Start Date
March 1 2006
End Date
October 1 2008
Last Update
April 18 2017
Active Locations (1)
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1
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139