Imaginal Exposure & D-Cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: D-cycloserine 100 mg on days of therapy session |
Drug: DCS
1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times)
|
| Placebo Comparator: Placebo Sugar pill |
Other: Placebo
2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times)
|
Outcome Measures
Primary Outcome Measures
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
English-speaking adults
-
Age 18-70
-
Survivor of a variety of traumas (e.g., motor vehicle and accidents, burns and others injuries, combat, World Trade Center attack, etc.)
-
Diagnosed with PTSD
-
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:
-
Current organic mental disorder
-
Schizophrenia or symptoms of psychosis/delusions
-
Bipolar disorder
-
Current substance abuse or dependence
-
Active suicidal/homicidal ideation, intent, or plan
-
Use of pacemaker
-
Significant health impairment, including renal disease
-
Taking oral anticoagulant medication, ethionamide (Trecator-SC), isoniazid (INH), or anti-depressant medication
-
Hypersensitivity to cycloserine
-
History of seizures
-
Pregnant or currently trying to conceive, or breastfeeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Weill Cornell Medical College | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Weill Medical College of Cornell University
Investigators
- Principal Investigator: JoAnn Difede, PhD, Weill Medical College of Cornell University
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 0802009646
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | D-cycloserine | Placebo |
|---|---|---|
| Arm/Group Description | DCS: 1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times) | Placebo: 2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times) |
| Period Title: Overall Study | ||
| STARTED | 20 | 21 |
| COMPLETED | 16 | 16 |
| NOT COMPLETED | 4 | 5 |
Baseline Characteristics
| Arm/Group Title | D-cycloserine | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | DCS: 1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times) | Placebo: 2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times) | Total of all reporting groups |
| Overall Participants | 20 | 21 | 41 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
44.50
(11.75)
|
40.71
(9.83)
|
42.56
(10.84)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
8
40%
|
12
57.1%
|
20
48.8%
|
| Male |
12
60%
|
9
42.9%
|
21
51.2%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White |
14
70%
|
16
76.2%
|
30
73.2%
|
| Black |
2
10%
|
2
9.5%
|
4
9.8%
|
| Hispanic |
4
20%
|
1
4.8%
|
5
12.2%
|
| Asian |
0
0%
|
1
4.8%
|
1
2.4%
|
| Other |
0
0%
|
1
4.8%
|
1
2.4%
|
| CAPS (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
97.20
(17.36)
|
97.43
(17.37)
|
97.31
(17.15)
|
Outcome Measures
| Title | Symptoms of Posttraumatic Stress Disorder-Clinician Administered PTSD Scale (CAPS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | D-cycloserine | Placebo |
|---|---|---|
| Arm/Group Description | DCS: 1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times) | Placebo: 2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times) |
| Measure Participants | 13 | 14 |
| Mean (Standard Deviation) [units on a scale] |
32.31
(32.31)
|
26.93
(25.06)
|
Adverse Events
| Time Frame | 14 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | D-cycloserine | Placebo | ||
| Arm/Group Description | DCS: 1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times) | Placebo: 2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times) | ||
All Cause Mortality |
||||
| D-cycloserine | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/21 (0%) | ||
Serious Adverse Events |
||||
| D-cycloserine | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/21 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| D-cycloserine | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/21 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Program director |
|---|---|
| Organization | Weil Cornell Medical College |
| Phone | 212 821 0783 |
| jdifede@med.cornell.edu |
- 0802009646