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

This study has been completed.

Sponsored by: Hartford Hospital
Information provided by: Hartford Hospital
ClinicalTrials.gov Identifier: NCT00131339
  Purpose

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.


Condition Intervention
Panic Disorder
Behavioral: Cognitive behavioral therapy
Drug: D-cycloserine

MedlinePlus related topics:   Anxiety    Panic Disorder   

ChemIDplus related topics:   Cycloserine    Aspartic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Panic Disorder

Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • significant reduction in panic symptoms after completion of treatment

Estimated Enrollment:   40
Study Start Date:   November 2004
Study Completion Date:   March 2007

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131339

Locations
United States, Connecticut
Hartford Hospital    
      Hartford, Connecticut, United States, 06106
United States, Massachusetts
Center for Anxiety and Related Disorders at Boston University    
      Boston, Massachusetts, United States, 02215

Sponsors and Collaborators
Hartford Hospital

Investigators
Principal Investigator:     Michael W. Otto, Ph.D.     Center for Anxiety and Related Disorders at Boston University    
  More Information


This link will connect you to the main website of the Anxiety Disorders Center at the Institute of Living in Hartford, CT  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   TOLI001428HI
First Received:   August 16, 2005
Last Updated:   April 12, 2007
ClinicalTrials.gov Identifier:   NCT00131339
Health Authority:   United States: Institutional Review Board

Keywords provided by Hartford Hospital:
panic disorder  
cognitive behavioral therapy  
D-cycloserine  
medication  
treatment trial
placebo-controlled
double-blind
randomized

Study placed in the following topic categories:
Cycloserine
Panic Disorder
Anxiety Disorders
Mental Disorders
N-Methylaspartate

Additional relevant MeSH terms:
Antimetabolites
Anti-Bacterial Agents
Anti-Infective Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Infective Agents, Urinary
Antitubercular Agents
Renal Agents
Pharmacologic Actions
Antibiotics, Antitubercular

ClinicalTrials.gov processed this record on October 03, 2008




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