D-serine for Posttraumatic Stress Disorder Treatment
2 other identifiers
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2003
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 18, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedJuly 9, 2012
July 1, 2012
4.8 years
September 18, 2005
July 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
CAPS scores
6 week treatment
Study Arms (2)
1
PLACEBO COMPARATORAdjuvant 6 weeks treatment with placebo (\~2g /day)
2
EXPERIMENTALAdjuvant 6 weeks treatment with D-serine (\~2g /day)
Interventions
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 Criteria
You may qualify if:
- Chronic PTSD (DSM-IV diagnosis)
You may not qualify if:
- Other psychiatric diagnosis
- Substance abuse
- Unstable medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herzog Hospitallead
Study Sites (1)
Ezrat Nashim-Herzog Memorial Hospital
Jerusalem, 91351, Israel
Related Publications (1)
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.
PMID: 19366490DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Uriel Heresco-Levy, M.D
Ezrat Nashim-Herzog Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 18, 2005
First Posted
September 22, 2005
Study Start
August 1, 2003
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
July 9, 2012
Record last verified: 2012-07