Schizophrenia Clinical Trial
Official title:
High Dose D-Serine as Adjuvant Treatment for Recent Onset Schizophrenia : A Randomized, Double-Blind, Placebo-Controlled Study
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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