Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128401
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2005-08-08
Brief Title:
Use of an Antibiotic as an Enhancer for the Treatment of Social Phobia
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effect of D-Cycloserine on Treatment of Social Phobia
Status:
COMPLETED
Status Verified Date:
2014-04
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:
This study examines whether an antibiotic d-cycloserine DCS boosts the effectiveness of cognitive behavior therapy CBT for social anxiety CBT has been shown to be effective for the treatment of social anxiety in children and adults but even after treatment approximately 40 may remain diagnosable The antibiotic DCS has been shown to enhance the type of learning that is promoted by exposure therapy a main component of CBT This study will test whether DCS can improve the effectiveness of CBT for social anxiety
All participants will receive 12 weekly CBT sessions In addition to receiving the CBT participants will be randomly assigned similar to a coin toss to receive either DCS or a placebo sugar pill The pill will be taken 1-2 hours prior to each of the 12 CBT sessions The pill is taken only on the 12 therapy days
Prior to receiving treatment participants will be asked to
participate in interviews to assess diagnosis and how they are doing including mood degree of nervousness and behavior
have a physical examination a urine test and an electrocardiogram EKG
undergo tests involving problem-solving and memory
prepare and present a speech to a virtual audience using virtual reality goggles
undergo functional magnetic resonance imaging fMRI while performing tasks that involve looking at pictures remembering things testing reaction times and making simple choices
Those who have not improved by the end of the study will be offered standard antianxiety medication treatment for 1 to 3 months If a participant does not wish to take medication study clinicians will help himher locate psychological care in the community Participants will be asked to complete a follow-up assessment 3 months after their last CBT session
All participants will receive 12 weekly CBT sessions In addition to receiving the CBT participants will be randomly assigned similar to a coin toss to receive either DCS or a placebo sugar pill The pill will be taken 1-2 hours prior to each of the 12 CBT sessions The pill is taken only on the 12 therapy days
Prior to receiving treatment participants will be asked to
participate in interviews to assess diagnosis and how they are doing including mood degree of nervousness and behavior
have a physical examination a urine test and an electrocardiogram EKG
undergo tests involving problem-solving and memory
prepare and present a speech to a virtual audience using virtual reality goggles
undergo functional magnetic resonance imaging fMRI while performing tasks that involve looking at pictures remembering things testing reaction times and making simple choices
Those who have not improved by the end of the study will be offered standard antianxiety medication treatment for 1 to 3 months If a participant does not wish to take medication study clinicians will help himher locate psychological care in the community Participants will be asked to complete a follow-up assessment 3 months after their last CBT session
Detailed Description:
Social phobia afflicts between 3-15 of the US population As such it is a particularly common debilitating psychiatric disorder Like many anxiety disorders social phobia typically arises during adolescence Treatment has consisted of medication or cognitive behavioral therapy CBT Selective Serotonin Reuptake Inhibitors SSRIs represent the first-line pharmacological treatment both in adults as well as adolescents APA Treatment Guidelines 2004 Similarly CBT significantly improves outcome in both age groups This treatment consists of psychoeducation exposure therapy and cognitive restructuring While both treatments produce clinically meaningful benefits most patients exhibiting positive responses to these treatments continue to exhibit marked residual symptoms if not full-blown anxiety disorders Thus there is great need for treatment advances
Intense fear of social scrutiny represents a core component of social phobia and extinction of this fear represents the goal of exposure therapy during CBT Cohn and Hope Finding treatments that facilitate extinction is of paramount importance In animals extinction involves an active learning process that is blocked by glutamatergic NMDA antagonists and facilitated by NMDA agonists Specifically administration of D-cycloserine DCS a partial agonist at the glycine modulatory site on the NMDA receptor produces a dose-dependent facilitation of extinction in the rat As such DCS might facilitate extinction during exposure-based CBT Indeed Ressler Ressler et al 2004 recently reported preliminary data from a clinical trial supporting this hypothesis
We will examine the degree to which DCS treatment can augment the clinical response in social phobia to CBT-exposure-based therapy Specifically we will study two groups of individuals with social phobia both of whom will receive CBT One group will receive placebo a second group will receive 50 mg of D-cycloserine 1-2 hours before each exposure therapy session We hypothesize that compared to placebo DCS will produce greater reductions in social anxiety symptoms following CBT treatment Finally given that chronic social anxiety disorder virtually always begins during childhood it is particularly vital to develop early interventions for the disorder Accordingly our trial will examine both adolescents and adults with the disorder
Intense fear of social scrutiny represents a core component of social phobia and extinction of this fear represents the goal of exposure therapy during CBT Cohn and Hope Finding treatments that facilitate extinction is of paramount importance In animals extinction involves an active learning process that is blocked by glutamatergic NMDA antagonists and facilitated by NMDA agonists Specifically administration of D-cycloserine DCS a partial agonist at the glycine modulatory site on the NMDA receptor produces a dose-dependent facilitation of extinction in the rat As such DCS might facilitate extinction during exposure-based CBT Indeed Ressler Ressler et al 2004 recently reported preliminary data from a clinical trial supporting this hypothesis
We will examine the degree to which DCS treatment can augment the clinical response in social phobia to CBT-exposure-based therapy Specifically we will study two groups of individuals with social phobia both of whom will receive CBT One group will receive placebo a second group will receive 50 mg of D-cycloserine 1-2 hours before each exposure therapy session We hypothesize that compared to placebo DCS will produce greater reductions in social anxiety symptoms following CBT treatment Finally given that chronic social anxiety disorder virtually always begins during childhood it is particularly vital to develop early interventions for the disorder Accordingly our trial will examine both adolescents and adults with the disorder
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-M-0198 | None | None | None |