Augmenting Exposure Therapy With an N-Methyl-D-Aspartate (NMDA) Agonist for Panic Disorder

This study has been completed.
Sponsor:
Information provided by:
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT00131339
First received: August 16, 2005
Last updated: August 25, 2009
Last verified: August 2009

August 16, 2005
August 25, 2009
November 2004
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significant reduction in panic symptoms after completion of treatment
Same as current
Complete list of historical versions of study NCT00131339 on ClinicalTrials.gov Archive Site
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Augmenting Exposure Therapy With an N-Methyl-D-Aspartate (NMDA) Agonist for Panic Disorder
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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Panic Disorder
  • Behavioral: Cognitive behavioral therapy
  • Drug: D-cycloserine
Not Provided
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.
 
Completed
40
March 2007
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Inclusion Criteria:

  • Principal diagnosis of panic disorder

Exclusion Criteria:

  • History of psychotic disorders or bipolar disorder
  • Substance dependence
  • Pregnant or breastfeeding
  • History of a medical condition that may increase the risks of taking the study drug
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00131339
TOLI001428HI
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Hartford Hospital
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Principal Investigator: Michael W. Otto, Ph.D. Center for Anxiety and Related Disorders at Boston University
Hartford Hospital
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP