Social Anxiety Disorder Clinical Trial
Official title:
A Single-center, Randomized, Double-blind, Phase III Comparison of the Efficacy and Safety of Quetiapine Fumarate (Oral Extended Release Tablets) to Placebo in Social Phobia Patients and Changes in Their Vasodilatory Response to Methyl-Nicotinate
To add to our understanding of the relationship between blushing, symptom severity and
potential mechanisms that underlie blushing in patients with Social Phobia (SP), the
investigators propose comparing SP patients' vascular responses to topical m-N pre and post
treatment with Seroquel or placebo.
Atypical antipsychotics such as seroquel have been used successfully as adjunctive
treatments in other anxiety disorders, including PTSD (Labatte, 2001; Krashin & Oates, 1999;
McDougle et al., 2000; Pfanner et al., 2000; Bogetto et al., 2000) and Generalized Anxiety
Disorder (Katzman et al., 2005). Responses to the blushing exposure will be assessed prior
to and following treatment with seroquel or placebo and at one month following intervention.
Levels of prostaglandin will be compared between groups and will also be correlated with
symptom severity in the clinical groups.
The objective of this randomized, double blind flexible -dose study will be to evaluate the
efficacy , safety and tolerability of seroquel SR 50mg to 800mg and placebo in outpatient
subjects diagnosed with SP. The study will begin with a single week of Seroquel 50mg or
placebo. Subsequently, tablets will be administered by the investigator in a flexible dose
fashion during the visits. Patients will be followed up weekly (biweekly after week 6) and
at the clinician's discretion. After the fist week the patients' dosage will be increased up
to a maximum of 800 mg daily with expected average dose of 300mg dail. This dose will remain
fixed after 8 weeks of treatment until week 16.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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