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NCT00215878 Clinical Trial

D-serine for Posttraumatic Stress Disorder Treatment

Posttraumatic Stress Disorder Clinical Trial

Official title:
D-serine for Posttraumatic Stress Disorder Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00215878
Other study ID # Heresco2CTIL
Secondary ID 20030311
Status Completed
Phase Phase 2
First received September 18, 2005
Last updated July 5, 2012
Start date August 2003
Est. completion date May 2008

Study information
Verified date July 2012
Source Herzog Hospital
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 75 Years
Eligibility Inclusion Criteria:

• Chronic PTSD (DSM-IV diagnosis)

Exclusion Criteria:

- Other psychiatric diagnosis

- Substance abuse

- Unstable medical condition

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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)

Locations
Country Name City State
Israel Ezrat Nashim-Herzog Memorial Hospital Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Herzog Hospital

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary CAPS scores 6 week treatment No
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