Imaginal Exposure & D-Cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD)

• Status: Terminated
• Trial end date: 2018-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Cycloserine

Criteria

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