Augmenting Exposure Therapy With an N-Methyl-D-Aspartate (NMDA) Agonist for Panic Disorder
|First Received Date ICMJE||August 16, 2005|
|Last Updated Date||August 25, 2009|
|Start Date ICMJE||November 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||significant reduction in panic symptoms after completion of treatment|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00131339 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Augmenting Exposure Therapy With an N-Methyl-D-Aspartate (NMDA) Agonist for Panic Disorder|
|Official Title ICMJE||Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Panic Disorder|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Condition ICMJE||Panic Disorder|
|Study Arm (s)||Not Provided|
|Publications *||Otto MW, Tolin DF, Simon NM, Pearlson GD, Basden S, Meunier SA, Hofmann SG, Eisenmenger K, Krystal JH, Pollack MH. Efficacy of d-cycloserine for enhancing response to cognitive-behavior therapy for panic disorder. Biol Psychiatry. 2010 Feb 15;67(4):365-70. Epub 2009 Oct 6.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||March 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00131339|
|Other Study ID Numbers ICMJE||TOLI001428HI|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Hartford Hospital|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Hartford Hospital|
|Verification Date||August 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP