Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131339
Status:
COMPLETED
Last Update Posted:
2009-08-26
First Post:
2005-08-16
Brief Title:
Augmenting Exposure Therapy With an N-Methyl-D-Aspartate NMDA Agonist for Panic Disorder
Sponsor:
Hartford Hospital
Organization:
Hartford Hospital
Study Overview
Official Title:
Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Panic Disorder
Status:
COMPLETED
Status Verified Date:
2009-08
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 involves cognitive behavioral therapy CBT and a medication called D-cycloserine DCS which is thought to help reduce panic symptoms more effectively by interacting with N-methyl-D-aspartate NMDA glutamate receptors facilitating many forms of learning including the extinction of fear Participants will be randomly assigned like flipping a coin to receive either DCS or a placebo in addition to CBT
Detailed Description:
This study consists of cognitive behavioral therapy CBT including exposure to physical sensations and feared situations which have been demonstrated to be effective for many individuals with panic disorder
All assessments and treatment sessions are free of charge Half of the patients will be randomly assigned to receive D-cycloserine DCS and half wll be assigned to receive a placebo Although DCS is used in humans to treat tuberculosis it has not been FDA approved for this indication Recent research in other anxiety disorders has shown that DCS plus behavior therapy is more effective than behavior therapy alone
This treatment study had two active interventions All patients will receive CBT and the researchers expect that everybody will improve from this treatment However it may be that those patients in the DCS intervention will improve somewhat more than those in the placebo intervention
The treatment will be structured with at home practice and repeated assessments Assessments are extremely important as they guide the treatment and provide the study investigators necessary information about the treatment The treatment consists of 5 sessions once a week plus a one week post-treatment assessment and follow-up assessments at one month and six months
All assessments and treatment sessions are free of charge Half of the patients will be randomly assigned to receive D-cycloserine DCS and half wll be assigned to receive a placebo Although DCS is used in humans to treat tuberculosis it has not been FDA approved for this indication Recent research in other anxiety disorders has shown that DCS plus behavior therapy is more effective than behavior therapy alone
This treatment study had two active interventions All patients will receive CBT and the researchers expect that everybody will improve from this treatment However it may be that those patients in the DCS intervention will improve somewhat more than those in the placebo intervention
The treatment will be structured with at home practice and repeated assessments Assessments are extremely important as they guide the treatment and provide the study investigators necessary information about the treatment The treatment consists of 5 sessions once a week plus a one week post-treatment assessment and follow-up assessments at one month and six months
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