D-serine for Posttraumatic Stress Disorder Treatment
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- CAPS scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 25 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Chronic PTSD (DSM-IV diagnosis)
Exclusion Criteria
- •Other psychiatric diagnosis
- •Substance abuse
- •Unstable medical condition
Arms & Interventions
1
Adjuvant 6 weeks treatment with placebo (~2g /day)
Intervention: D-serine (~2g /day) (Drug)
2
Adjuvant 6 weeks treatment with D-serine (~2g /day)
Intervention: D-serine (~2g /day) (Drug)
Outcomes
Primary Outcomes
CAPS scores
Time Frame: 6 week treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Heresco-Levi Uriel
Principal Investigator
Herzog Hospital