A Phase 2 interventional study of D-serine in Schizophrenia, sponsored by Hadassah Medical Organization. Status unknown at 2 sites in Israel. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2011-10-25.
Sponsored by Hadassah Medical Organization · Phase 2, Interventional, and Treatment
The purpose of this study is to compare efficacy and safety of add-on treatment with a moderately high dose of D-serine, an NMDA-glycine site agonist, in young, recent onset schizophrenia patients who suffer from significant symptoms despite treatment with antipsychotics.
Background: Recent advances in understanding the neurobiology underlying schizophrenia have underscored a pivotal role for a specific receptor for the neurotransmitter glutamate, the NMDA receptor, whose function may be impaired in the disorder. Enhancing transmission at the NMDA receptor may therefore provide a novel mechanism for treating schizophrenia. Over the past decade clinical trials that included supplementation with different compounds enhancing transmission at the NMDA receptor have provided positive results, particularly with D-serine. However, none of these trials focused specifically on young patients with recent onset schizophrenia. In addition, the optimal D-serine dose was not determined, although a preliminary report suggested that higher doses than those used in most studies may provide additional benefit, without significant safety concerns or side effects. Also, the pro-cognitive effects of D-serine were not systematically analyzed, although preliminary data supports a potential role for D-serine in ameliorating the cognitive deficits found in schizophrenia.
Research Design: Over a two year period, 54 patients, male or female, aged 18-30 years who fulfill DSM-IV criteria for schizophrenia or schizoaffective disorder, will be entered into a 12 week, parallel group, double blind, randomized controlled trial assessing the efficacy of placebo vs. DSR (up to 6000 mg/day) augmentation to standard antipsychotic therapy. First episode patients, and patients treated with clozapine, will be randomized separately. Patients will be entered into the trial in accordance with strict inclusion and exclusion criteria after the nature of the study has been explained to them and they have given written informed consent. Clinical evaluations will be performed at baseline and then at regular intervals during the trial. In addition, neurocognitive evaluations, electrophysiological assessments and determination of amino acids levels will be conducted at the beginning and end of the study. Treatment emergent adverse effects will be monitored.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's planned enrollment of 54 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
D-serine up to 6000 mg/day subject to tolerability
Drug: D-serine
Treatment with inert capsules (placebo)
Drug: D-serine
Adjuvant treatment with D-serine up to 6000 mg/day vs. placebo
Change from Baseline in the Total Score of the Positive and Negative Syndrome Scale (PANSS)
Time frame: Biweekly for 12 weeks
Change from Baseline in the Composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Battery
Time frame: 12 weeks
Change from Baseline in the Subscales of PANSS
Time frame: Biweekly for 12 weeks
Change from Baseline in the Clinical Global Impressions (CGI)
Time frame: Biweekly for 12 weeks
Change from Baseline in the Scale for the Assessment of Negative Symptoms (SANS)
Time frame: Biweekly for 12 weeks
Change from Baseline in the Calgary Depression Scale for Schizophrenia (CDSS
Time frame: Biweekly for 12 weeks
Change from Baseline in the Quality of Life Scale (QOL)
Time frame: Biweekly for 12 weeks
Change from Baseline in the Simpson-Angus Extrapyramidal Rating Scale (SAS)
Time frame: Biweekly for 12 weeks
Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS)
Time frame: Biweekly for 12 weeks
Change from Baseline in the Udvalg for Kliniske Undersgelser (UKU) Side Effect Rating Scale
Time frame: Biweekly for 12 weeks
Change from Baseline in the Prepulse Inhibition (PPI) of Startle
Patients with schizophrenia and their relatives may exhibit deficits in this operational measure of sensorimotor gating
Time frame: 12 weeks
Amino Acid Serum Levels
Glutamate, Glycine, D-serine
Time frame: 12 weeks
This study is status unknown, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Hadassah Medical Organization