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NCT00215917 Clinical Trial

D-Serine Monotherapy for Schizophrenia

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00215917
Other study ID # lichtenberg1CTIL
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received September 18, 2005
Last updated May 1, 2006

Study information
Verified date May 2006
Source Herzog Hospital
Contact Pesach Lichtenberg, M.D.
Phone 972-2-6221154
Email licht@cc.huji.ac.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

N-methyl-D-aspartate receptor (NMDAR) agonist, added to classical or atypical antipsychotic medication, has reduced negative, depressive, and cognitive symptomatology. We will be investigating the effect of D-serine, (DSR), a selective and potent NMDAR agonist, as monotherapy for treatment resistant schizophrenics.

40 subjects on stable doses of risperidone will be randomized under double-blind conditions into a treatment group, which will receive D-serine 2100 mg, or a control group, which will continue to receive risperidone. Treatment will continue for 14 weeks.

Symptoms and side effects will be rated biweekly with the CGI, PANSS, BPRS, SAS, AIMS, and UKU. Before and after the trial subjects will undergo neuropsychological assessments. Baseline and post-trial levels of amino acids relevant to glutamatergic neurotransmission (glutamate, glutamine, aspartate, glycine, serine, alanine) will be assessed.

The primary outcome measures of the study will be the PANSS total scores and the positive and negative symptom cluster scores.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. DSM-IV criteria for chronic schizophrenia

2. Treatment resistant

3. aged 18-70

4. Two months on stable risperidone dose

5. PANSS positive symptom cluster score >20

6. PANSS negative symptom cluster score >22

Exclusion Criteria:

1. Substance abuse

2. Concurrent DSM IV axis I disorder

3. Serious medical disorder

4. Concurrent drug therapy that can obscure the effect of risperidone or DSR.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• D-serine 2100 mg daily

Locations
Country Name City State
Israel Herzog Hospital, Department of Psychiatry Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Herzog Hospital

Country where clinical trial is conducted

Israel, 

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