Ignite Creation Date:
2024-05-05 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00773162
Status:
COMPLETED
Last Update Posted:
2014-02-25
First Post:
2008-10-15
Brief Title:
Flushing in Social Anxiety Disorder on Seroquel
Sponsor:
START Clinic for Mood and Anxiety Disorders
Organization:
START Clinic for Mood and Anxiety Disorders
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 clinicians 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
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 clinicians 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None