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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
History of Changes
  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:

Drug Information available for: Serine
U.S. FDA Resources

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
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:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013