Back to resultsD-serine for Posttraumatic Stress Disorder Treatment
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
D-serine (~2g /day)
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria: • Chronic PTSD (DSM-IV diagnosis) Exclusion Criteria: Other psychiatric diagnosis Substance abuse Unstable medical condition
Sites / Locations
- Ezrat Nashim-Herzog Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Adjuvant 6 weeks treatment with placebo (~2g /day)
Adjuvant 6 weeks treatment with D-serine (~2g /day)
Outcomes
Primary Outcome Measures
CAPS scores
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00215878
Brief Title
D-serine for Posttraumatic Stress Disorder Treatment
Official Title
D-serine for Posttraumatic Stress Disorder Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herzog Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Adjuvant 6 weeks treatment with placebo (~2g /day)
Arm Title
2
Arm Type
Experimental
Arm Description
Adjuvant 6 weeks treatment with D-serine (~2g /day)
Intervention Type
Drug
Intervention Name(s)
D-serine (~2g /day)
Intervention Description
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 Measure Information:
Title
CAPS scores
Time Frame
6 week treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Chronic PTSD (DSM-IV diagnosis)
Exclusion Criteria:
Other psychiatric diagnosis
Substance abuse
Unstable medical condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uriel Heresco-Levy, M.D
Organizational Affiliation
Ezrat Nashim-Herzog Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ezrat Nashim-Herzog Memorial Hospital
City
Jerusalem
ZIP/Postal Code
91351
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
19366490
Citation
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.
Results Reference
derived
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D-serine for Posttraumatic Stress Disorder Treatment
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