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

NCT ID: NCT00131339

Last Updated: 2009-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Panic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Cognitive behavioral therapy

Intervention Type BEHAVIORAL

D-cycloserine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hartford Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Michael W. Otto, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Center for Anxiety and Related Disorders at Boston University

Locations

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Hartford Hospital

Hartford, Connecticut, United States

Site Status

Center for Anxiety and Related Disorders at Boston University

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/j.biopsych.2009.07.036. Epub 2009 Oct 6.

Reference Type DERIVED
PMID: 19811776 (View on PubMed)

Other Identifiers

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TOLI001428HI

Identifier Type: -

Identifier Source: org_study_id

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