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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Panic Disorder

Resource links provided by NLM:


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

Additional Information:
No publications provided by Hartford Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00131339     History of Changes
Other Study ID Numbers: TOLI001428HI
Study First Received: August 16, 2005
Last Updated: August 25, 2009
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

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders
N-Methylaspartate
Cycloserine
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites

ClinicalTrials.gov processed this record on April 15, 2014