D-serine for Posttraumatic Stress Disorder Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00215878
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 9, 2012
Information provided by (Responsible Party):
Heresco-Levi Uriel, Herzog Hospital

September 18, 2005
September 22, 2005
July 9, 2012
August 2003
May 2008   (Final data collection date for primary outcome measure)
CAPS scores [ Time Frame: 6 week treatment ]
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Complete list of historical versions of study NCT00215878 on 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.

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Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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. doi: 10.1017/S1461145709000339. Epub 2009 Apr 15.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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
Sexes Eligible for Study: All
25 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Heresco-Levi Uriel, Herzog Hospital
Herzog Hospital
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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