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NCT00131339 Clinical Trial

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

Panic Disorder Clinical Trial

Official title:
Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Panic Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00131339
Other study ID # TOLI001428HI
Secondary ID
Status Completed
Phase N/A
First received August 16, 2005
Last updated August 25, 2009
Start date November 2004
Est. completion date March 2007

Study information
Verified date August 2009
Source Hartford Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Cognitive behavioral therapy

Drug:
• D-cycloserine

Locations
Country Name City State
United States Center for Anxiety and Related Disorders at Boston University Boston Massachusetts
United States Hartford Hospital Hartford Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary significant reduction in panic symptoms after completion of treatment
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