D-serine for Posttraumatic Stress Disorder Treatment

NCT ID: NCT00215878

Last Updated: 2012-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Adjuvant 6 weeks treatment with placebo (\~2g /day)

Group Type PLACEBO_COMPARATOR

D-serine (~2g /day)

Intervention Type DRUG

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)

2

Adjuvant 6 weeks treatment with D-serine (\~2g /day)

Group Type EXPERIMENTAL

D-serine (~2g /day)

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

• Chronic PTSD (DSM-IV diagnosis)

Exclusion Criteria

* Other psychiatric diagnosis
* Substance abuse
* Unstable medical condition
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herzog Hospital

OTHER

Sponsor Role lead

Responsible Party

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Heresco-Levi Uriel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Uriel Heresco-Levy, M.D

Role: PRINCIPAL_INVESTIGATOR

Ezrat Nashim-Herzog Memorial Hospital

Locations

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Ezrat Nashim-Herzog Memorial Hospital

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 19366490 (View on PubMed)

Other Identifiers

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20030311

Identifier Type: -

Identifier Source: secondary_id

Heresco2CTIL

Identifier Type: -

Identifier Source: org_study_id