D-Serine Monotherapy for Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00215917|
Recruitment Status : Unknown
Verified May 2006 by Herzog Hospital.
Recruitment status was: Recruiting
First Posted : September 22, 2005
Last Update Posted : May 3, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: D-serine 2100 mg daily||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215917
|Contact: Pesach Lichtenberg, M.D.||email@example.com|
|Herzog Hospital, Department of Psychiatry||Recruiting|
|Jerusalem, Israel, 91351|
|Contact: Pesach Lichtenberg, M.D. 972-2-5316929 firstname.lastname@example.org|
|Principal Investigator:||Pesach Lichtenberg, M.D.||Herzog Hospital, and Hadassah Medical School--the Hebrew University of Jerusalem, Israel|