D-serine for Posttraumatic Stress Disorder Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heresco-Levi Uriel, Herzog Hospital
ClinicalTrials.gov Identifier:
NCT00215878
First received: September 18, 2005
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

The aim of this study is to asses the effects of the NMDA receptor full agonist D-serine while used as adjuvant treatment for individuals suffering from chronic posttraumatic stress disorder (PTSD). Dysfunction of neurotransmission mediated at NMDA receptor plays a cardinal role in the pathophysiology of PTSD and PTSD patients typically suffer from cognitive dysfunctions and avoidance& depressive symptomatology that may be mediated by NMDA receptor function deficits.

Thus, enhancement of NMDA activity by using D-serine may be beneficial in the treatment of PTSD. The study design involves two 6 week periods during which the participants will be randomly assigned to receive treatment with D-serine (~2g /dy)and placebo. This design allows each participant the opportunity to respond to the experimental treatment.


Condition Intervention Phase
Posttraumatic Stress Disorder
Drug: D-serine (~2g /day)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: D-serine for Posttraumatic Stress Disorder Treatment

Resource links provided by NLM:


Further study details as provided by Herzog Hospital:

Primary Outcome Measures:
  • CAPS scores [ Time Frame: 6 week treatment ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: August 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Adjuvant 6 weeks treatment with placebo (~2g /day)
Drug: D-serine (~2g /day)
Two 6 weeks treatment arms under a cross over design. In one arm adjuvant treatment with experimental medication (D-serine ~2g /day), in the second arm adjuvant treatment with placebo (~2g /day)
Experimental: 2
Adjuvant 6 weeks treatment with D-serine (~2g /day)
Drug: D-serine (~2g /day)
Two 6 weeks treatment arms under a cross over design. In one arm adjuvant treatment with experimental medication (D-serine ~2g /day), in the second arm adjuvant treatment with placebo (~2g /day)

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Chronic PTSD (DSM-IV diagnosis)

Exclusion Criteria:

  • Other psychiatric diagnosis
  • Substance abuse
  • Unstable medical condition
  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: NCT00215878

Locations
Israel
Ezrat Nashim-Herzog Memorial Hospital
Jerusalem, Israel, 91351
Sponsors and Collaborators
Herzog Hospital
Investigators
Principal Investigator: Uriel Heresco-Levy, M.D Ezrat Nashim-Herzog Memorial Hospital
  More Information

No publications provided by Herzog Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heresco-Levi Uriel, Principal Investigator, Herzog Hospital
ClinicalTrials.gov Identifier: NCT00215878     History of Changes
Other Study ID Numbers: Heresco2CTIL, 20030311
Study First Received: September 18, 2005
Last Updated: July 5, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014