| City: |
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Boston |
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State:
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MA |
| Zip Code: |
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02130 |
| Conditions: |
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Combat Disorders - Stress Disorders, Post-Traumatic |
| Purpose: |
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The primary aim of this project is to examine whether administration of D-Cycloserine (DCS),
a partial NMDA receptor agonist that has been shown to facilitate fear extinction, enhances
the therapeutic benefit of exposure-based cognitive behavioral therapy (CBT) in OEF/OIF
veterans with PTSD.
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| Study summary: |
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War-zone-related posttraumatic stress disorder (PTSD) is a major psychiatric disorder that
includes specific disabling symptoms and impairments that interfere with a soldier's ability
to do his or her job. There is strong evidence for cognitive behavior therapy (CBT) in
treating PTSD in civilians, which suggests a prescription for returning veterans, but
approximately 40% of patients retain a PTSD diagnosis (e.g., Foa et al., 1999) and drop-out
rates are ~25%. It is imperative to develop novel evidence-based early interventions that
are more acceptable to recent veterans and less draining of treatment resources. If CBT can
be shortened and its efficacy boosted by cognitive enhancers then it is more likely that
soldiers will get the most efficacious treatments for acute stress and PTSD. Our aim is to
develop a program that is brief and effective, but will have long-term benefits for veterans
by virtue of its greater amenability to self-management and treatment adherence beyond the
therapy context.
This study is a randomized, controlled, double-blind treatment trial comparing CBT plus DCS
to CBT plus placebo. Participants will be 68 OEF/OIF veterans with PTSD randomly assigned
to CBT plus DCS or CBT plus placebo. Procedures to screen subjects prior to randomization
include a detailed phone screen, administration and collection of questionnaires, a medical
assessment, and two baseline structured clinical interviews. Following randomization, both
groups will receive the identical 6 session exposure-based CBT protocol. The DCS-augmented
group will receive 50 mg of DCS 30 minutes prior to the four CBT sessions involving imaginal
exposure, whereas the placebo-augmented group will receive a placebo pill prior to these
sessions. Assessment interviews conducted by independent evaluators will occur at
pre-treatment, post-treatment, and at 3, and 6-month follow-up. Self-report measures will
also be administered at screening, throughout the 6 weeks of treatment, and at 3- and 6-
month follow up.
Comparison(s): OEF/OIF veterans with PTSD treated with CBT plus DCS, compared to OEF/OIF
veterans with PTSD treated with CBT plus placebo. |
| Criteria: |
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Inclusion Criteria:
- Male or female outpatients 18 years of age or older who served in Operation Iraqi
Freedom or Operation Enduring Freedom (OIF/OEF) and who have a primary diagnosis
(designated by the patient as the most important source of distress of PTSD.
- Willingness and ability to comply with the requirements of the study protocol.
Exclusion Criteria:
A lifetime history of:
- bipolar disorder
- schizophrenia
- psychosis
- delusional disorders or obsessive-compulsive disorder
- organic brain syndrome
- cognitive dysfunction that could interfere with capacity to engage in therapy
- a history of substance or alcohol dependence (other than nicotine) in the last 6
months or otherwise unable to commit to refraining from alcohol use during the acute
period of study participation.
- Patients with significant suicidal ideation or who have enacted suicidal behaviors
within 6 months prior to intake will be excluded from study participation and
referred for appropriate services.
- Patients must be off concurrent psychotropic medication (e.g., antidepressants,
anxiolytics, beta blockers) for at least 2 weeks prior to initiation of randomized
treatment.
- Serious medical illness or instability for which hospitalization may be likely within
the next year.
- Patients with a current or past history of seizures
- Pregnant women, lactating women, and women of childbearing potential who are not
using medically accepted forms of contraception (e.g., IUD, oral contraceptives,
barrier devices, condoms and foam, or implanted progesterone rods stabilized for at
least 3 months).
- Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing
psychotherapy of any duration specifically targeting PTSD is excluded. General
supportive therapy initiated > 3 months prior is acceptable.
- Patients with seizures or ongoing severe cognitive impairment that compromised mental
status.
- Patients receiving Isoniazid.
- Patients unable to understand study procedures and participate in the informed
consent process.
- Patients with a history of renal insufficiency (creatinine clearance less than 50
mL/min). |
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| Study is available at: |
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VA Boston Health Care System
Boston, MA 02130
United States
Primary Contact:
Eileen Delaney, PhD
Email: eileen.delaney@va.gov
Phone: 857-364-5995
Secondary Contact:
Eileen Delaney, PhD
Email: eileen.delaney@va.gov
Phone: (857) 364-5995 |
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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 21, 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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