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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

September 18, 2005
July 5, 2012
August 2003
May 2008   (final data collection date for primary outcome measure)
CAPS scores [ Time Frame: 6 week treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00215878 on ClinicalTrials.gov Archive Site
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D-serine for Posttraumatic Stress Disorder Treatment
D-serine for Posttraumatic Stress Disorder Treatment

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Posttraumatic Stress Disorder
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)
  • Placebo Comparator: 1
    Adjuvant 6 weeks treatment with placebo (~2g /day)
    Intervention: Drug: D-serine (~2g /day)
  • Experimental: 2
    Adjuvant 6 weeks treatment with D-serine (~2g /day)
    Intervention: Drug: D-serine (~2g /day)
Heresco-Levy U, Vass A, Bloch B, Wolosker H, Dumin E, Balan L, Deutsch L, Kremer I. Pilot controlled trial of D-serine for the treatment of post-traumatic stress disorder. Int J Neuropsychopharmacol. 2009 Oct;12(9):1275-82. Epub 2009 Apr 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

• Chronic PTSD (DSM-IV diagnosis)

Exclusion Criteria:

  • Other psychiatric diagnosis
  • Substance abuse
  • Unstable medical condition
Both
25 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00215878
Heresco2CTIL, 20030311
Yes
Heresco-Levi Uriel, Herzog Hospital
Herzog Hospital
Not Provided
Principal Investigator: Uriel Heresco-Levy, M.D Ezrat Nashim-Herzog Memorial Hospital
Herzog Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP