Posttraumatic Stress Disorder
Conditions
Keywords
Traumatic Event, Trauma Survivor, Exposure Therapy, PTSD DCS, Telemedicine, Telepsychiatry, Telemental health
Brief summary
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 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.
Detailed description
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. 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.
Interventions
DRUGDCS
1\. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times)
OTHERPlacebo
2\. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times)
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of Posttraumatic Stress Disorder-Clinician Administered PTSD Scale (CAPS) | Immediately after the intervention, an average of 6 months | Clinician Administered PTSD Scale (CAPS). Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| D-cycloserine DCS: 1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times) | 20 |
| Placebo Placebo: 2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times) | 21 |
| Total | 41 |
Baseline characteristics
| Characteristic | D-cycloserine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 44.50 years STANDARD_DEVIATION 11.75 | 40.71 years STANDARD_DEVIATION 9.83 | 42.56 years STANDARD_DEVIATION 10.84 |
| CAPS | 97.20 units on a scale STANDARD_DEVIATION 17.36 | 97.43 units on a scale STANDARD_DEVIATION 17.37 | 97.31 units on a scale STANDARD_DEVIATION 17.15 |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 14 Participants | 16 Participants | 30 Participants |
| Sex: Female, Male Female | 8 Participants | 12 Participants | 20 Participants |
| Sex: Female, Male Male | 12 Participants | 9 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 |
| other Total, other adverse events | 0 / 20 | 0 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 |
Outcome results
Primary
Symptoms of Posttraumatic Stress Disorder-Clinician Administered PTSD Scale (CAPS)
Clinician Administered PTSD Scale (CAPS). Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms).
Time frame: Immediately after the intervention, an average of 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| D-cycloserine | Symptoms of Posttraumatic Stress Disorder-Clinician Administered PTSD Scale (CAPS) | 32.31 units on a scale | Standard Deviation 32.31 |
| Placebo | Symptoms of Posttraumatic Stress Disorder-Clinician Administered PTSD Scale (CAPS) | 26.93 units on a scale | Standard Deviation 25.06 |