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D-serine for Posttraumatic Stress Disorder Treatment

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ClinicalTrials.gov Identifier: NCT00215878
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 9, 2012
Sponsor:
Information provided by (Responsible Party):
Heresco-Levi Uriel, Herzog Hospital

Brief Summary:

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: D-serine for Posttraumatic Stress Disorder Treatment
Study Start Date : August 2003
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Serine

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. CAPS scores [ Time Frame: 6 week treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Chronic PTSD (DSM-IV diagnosis)

Exclusion Criteria:

  • Other psychiatric diagnosis
  • Substance abuse
  • Unstable medical condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders