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Sponsored by: |
Hartford Hospital |
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Information provided by: | Hartford Hospital |
ClinicalTrials.gov Identifier: | NCT00131339 |
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 |
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Panic Disorder |
Behavioral: Cognitive behavioral therapy Drug: D-cycloserine |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | November 2004 |
Study Completion Date: | March 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Michael W. Otto, Ph.D. | Center for Anxiety and Related Disorders at Boston University |
Study ID Numbers: | TOLI001428HI |
Study First Received: | August 16, 2005 |
Last Updated: | April 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00131339 |
Health Authority: | United States: Institutional Review Board |
panic disorder cognitive behavioral therapy D-cycloserine medication |
treatment trial placebo-controlled double-blind randomized |
Cycloserine Panic Disorder Anxiety Disorders Mental Disorders N-Methylaspartate |
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 |