Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035412
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2002-05-03
Brief Title:
St Johns Wort Versus Placebo in Social Phobia
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
St Johns Wort Versus Placebo in Social Phobia
Status:
COMPLETED
Status Verified Date:
2006-07
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:
The purpose of this study is to determine the effectiveness of St Johns Wort as compared to placebo an inactive substance in the treatment of outpatients with social phobia
Detailed Description:
Social Phobia is a prevalent and debilitating condition with a lifetime prevalence rate to be 133 percent Socially phobic patients have been found to be functionally impaired in the areas of education employment and social relationships to have poorer quality of life and increased suicidal ideation and psychiatric comorbidity Double-blind studies have found benzodiazepines selective and non-selective MAOI inhibitors several SSRIs and the anticonvulsants pregabalin and gabapentin to be effective However side effects with these compounds suggests the need for better tolerated compounds eg in the paroxetine multi-center trial the only drug with an FDA approved indication 27 percent reported somnolence 26 percent nausea and 37 percent of males reported delayed ejaculation 34 percent of patients discontinued the trial early There has been considerable worldwide interest in St Johns Wort SJW Hypericum perforatum as a treatment of mild to moderate depression There have been 23 randomized trials suggesting SJW is more effective than placebo for the treatment of outpatients with mild to moderate depression SJW is very well tolerated with mild side effects observed in only 25 percent of cases in a large 3250 patients drug monitoring study Pharmacokinetic studies have found Hypericum to have affinity for serotonin dopamine and GABA alpha and GABA beta receptors each of which have been implicated in social phobia thus there is a suggestion that SJW may be effective for this disorder
This will be a 12-week double blind placebo-controlled trial designed to generate effect size data that will be used to determine sample size needed to power a definitive study Forty patients will be randomized to either SJW LI 160 or matching placebo This will be a flexible-dose design starting at 300 mg tid to a maximum of 1800 mg total per day An intent-to-treat analysis will be employed Subjects will be evaluated weekly for two weeks then bi-weekly thereafter The primary outcome measure will be the change from baseline to endpoint on the Liebowitz Social Anxiety Scale
This will be a 12-week double blind placebo-controlled trial designed to generate effect size data that will be used to determine sample size needed to power a definitive study Forty patients will be randomized to either SJW LI 160 or matching placebo This will be a flexible-dose design starting at 300 mg tid to a maximum of 1800 mg total per day An intent-to-treat analysis will be employed Subjects will be evaluated weekly for two weeks then bi-weekly thereafter The primary outcome measure will be the change from baseline to endpoint on the Liebowitz Social Anxiety Scale
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