Flushing in Social Anxiety Disorder on Seroquel
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Mean change from baseline on the HAM-A, CGI, SF-36, LSAS, SPIN, SIAS, SPS, ASI, BAI, BDI, SHEEHAN, EUROQUEL, BIS/BAS, PSWQ, IUS [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|Placebo Comparator: 1||
Drug: Sugar Pill
Sugar pill to match seroquel
|Active Comparator: 2||
seroquel XR- oral extended release tablets, 50mg - 300mg, 16 weeks
Other Name: Quetiapine
|START Clinic for the Mood and Anxiety Disorders|
|Toronto, Ontario, Canada, M4W 2N4|
|Principal Investigator:||Martin A Katzman, MD||START Clinic for Mood and Anxiety Disorders|