Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Joann Difede, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00875342
First received: April 2, 2009
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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 Intervention
Posttraumatic Stress Disorder
Drug: DCS
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: D-cycloserine Enhanced Imaginal ExposureTherapy for Posttraumatic Stress Disorder (PTSD)

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • symptoms of Posttraumatic Stress Disorder-Clinician Administered PTSD Scale(CAPS) and PCL [ Time Frame: At initial assessment, during treatment, immediately following treatment, and 6 months after completion of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other measures include BDI, BSI, STAXI-2, Expectancy of Therapeutic Outcomes [ Time Frame: At initial assessment, during treatment, immediately following treatment, and 6 months after completion of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: May 2008
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: D-cycloserine 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 Other: Placebo
2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875342

Contacts
Contact: Judith Cukor, Ph. D. 212 746 4492 juc2010@med.cornell.edu
Contact: JoAnn Difede, Ph. D. 212 746 3079 jdifede@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Judith Cukor, Ph. D.    212-746-4492    juc2010@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: JoAnn Difede, PhD Weill Medical College of Cornell University
  More Information

Additional Information:
No publications provided

Responsible Party: Joann Difede, Professor of Psychology in Psychiatry, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00875342     History of Changes
Other Study ID Numbers: 0802009646
Study First Received: April 2, 2009
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Traumatic Event
Trauma Survivor
Exposure Therapy
PTSD DCS
Telemedicine
Telepsychiatry
Telemental health

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes
Cycloserine
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antibiotics, Antitubercular
Antimetabolites
Antitubercular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014