| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10065 |
| Conditions: |
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Posttraumatic Stress Disorder |
| Purpose: |
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This study proposes to evaluate the effects of D-cycloserine (DCS) combined with
cognitive-behavioral treatment with exposure therapy in a sample of patients who developed
posttraumatic stress disorder (PTSD) as a consequence of various traumas (e.g., motor
vehicle and accidents, burns and other injuries, combat, World Trade Center attack, etc.).
In addition, this study hopes to determine whether a common human genetic single nucleotide
polymorphism (SNP) in a growth factor, brain derived neurotrophic factor, BDNF SNP
(Val66Met), predicts treatment response to PTSD.
Patients living in areas that are not geographically proximal to the Weill-Cornell Medical
Center New York City campus (Vermont) will receive cognitive behavioral therapy using
telemedicine (videoconferencing technology).
Overall, this study aims 1) to determine if subjects administered DCS show a significantly
larger decrease in symptoms of PTSD as compared to those administered a placebo, 2) to
determine if subjects administered DCS show a decrease in PTSD symptomatology significantly
earlier (as measured by weeks) than those administered a placebo, 3) to determine if
differences in symptomatology are evident at a 6-month follow-up and indicate long-term
differences between groups, 4) to determine if the BDNF SNP predicts treatment response,
5)to determine if it is feasible and acceptable to provide imaginal exposure (IE) therapy
for PTSD using videoconferencing technology.
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| Study summary: |
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Following an initial assessment evaluating eligibility for the study, eligible participants
will be randomly assigned to one of two treatment groups: imaginal exposure (IE) plus DCS
(100mg) or IE plus placebo (sugar pill). DCS is a broad spectrum antibiotic that has
recently been implicated as a cognitive enhancer and may enhance the treatment that occurs.
The participant, assessor and treating clinicians will be blinded to which pill the
participant is receiving. The dose of medication will need to be taken only on the days of
therapy sessions during which the exposure occurs (approximately 9 times). Both groups will
be treated with a standardized cognitive-behavioral exposure therapy protocol utilizing
gold-standard treatment, consisting of 12-14 weekly individual (one-on-one) sessions with a
highly qualified clinical psychologist (for Vermont patients, using existing
videoconferencing technology located at the University of Vermont's Burlington Campus).
Treatment interventions include imaginal exposure, graduated in vivo exposure,
psycho-education, relaxation training, behavioral activation, and cognitive restructuring.
Assessments will occur prior to treatment, following sessions 3, 6 and 10, following
completion of treatment, and 6 months after the conclusion of treatment. In addition, all
participants will be genotyped once for the BDNF SNP (Val66Met) using a non-invasive saliva
sample. |
| Criteria: |
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Inclusion Criteria:
1. English-speaking adults
2. Age 18-70
3. Survivor of a variety of traumas (e.g., motor vehicle and accidents, burns and
others injuries, combat, World Trade Center attack, etc.)
4. Diagnosed with PTSD
5. In good health. For persons with chronic injuries/conditions related to their
accidents, "good health" is defined as the injury being in a state of stabilization
and able to attend weekly outpatient sessions.
Exclusion Criteria:
1. Current organic mental disorder
2. Schizophrenia or symptoms of psychosis/delusions
3. Bipolar disorder
4. Current substance abuse or dependence
5. Active suicidal/homicidal ideation, intent, or plan
6. Use of pacemaker
7. Significant health impairment, including renal disease
8. Taking oral anticoagulant medication, ethionamide (Trecator-SC), isoniazid (INH), or
anti-depressant medication
9. Hypersensitivity to cycloserine
10. History of seizures
11. Pregnant or currently trying to conceive, or breastfeeding |
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| Study is available at: |
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Weill Cornell Medical College
New York, NY 10065
United States
Primary Contact:
Judith Cukor, Ph. D.
Email: juc2010@med.cornell.edu
Phone: 212-746-4492
Secondary Contact:
Judith Cukor, Ph. D.
Email: juc2010@med.cornell.edu
Phone: 212 746 4492 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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