Schizophrenia Clinical Trial
— SATROSOfficial 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.
Status | Not yet recruiting |
Enrollment | 54 |
Est. completion date | October 2014 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Age 18-30 - Diagnosis of schizophrenia/schizoaffective disorder - Recent onset (up to five years since onset of positive symptoms) - Stable dose antipsychotic treatment for at least 4 weeks - Baseline PANSS total score of at least 70 - Baseline PANSS negative subscale score of at least 20 - Clinically stable (stable CGI score for two consecutive weeks) Exclusion Criteria: - Criteria for other DSM-IV Axis I diagnoses are met - Lifetime history of alcohol or substance dependence - Alcohol or substance abuse within the past year - Judged clinically to be at suicidal or homicidal risk - Female patients who are pregnant or lactating. - Patients with known intolerance to D-serine treatment - Patients treated with ECT within 12 weeks prior to study entry - Patients treated with TMS within 4 weeks prior to study entry - Patients suffering from an unstable and/or untreated medical disorder - Patients suffering from renal or hepatic dysfunction |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Ezrath Nashim - Herzog Memorial Hospital & Community Clinics | Jerusalem | |
Israel | Hadassah Medical Organization | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization | Herzog Hospital |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in the Total Score of the Positive and Negative Syndrome Scale (PANSS) | Biweekly for 12 weeks | No | |
Secondary | Change from Baseline in the Composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Battery | 12 weeks | No | |
Secondary | Change from Baseline in the Subscales of PANSS | Biweekly for 12 weeks | No | |
Secondary | Change from Baseline in the Clinical Global Impressions (CGI) | Biweekly for 12 weeks | No | |
Secondary | Change from Baseline in the Scale for the Assessment of Negative Symptoms (SANS) | Biweekly for 12 weeks | No | |
Secondary | Change from Baseline in the Calgary Depression Scale for Schizophrenia (CDSS | Biweekly for 12 weeks | No | |
Secondary | Change from Baseline in the Quality of Life Scale (QOL) | Biweekly for 12 weeks | No | |
Secondary | Change from Baseline in the Simpson-Angus Extrapyramidal Rating Scale (SAS) | Biweekly for 12 weeks | Yes | |
Secondary | Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) | Biweekly for 12 weeks | Yes | |
Secondary | Change from Baseline in the Udvalg for Kliniske Undersgelser (UKU) Side Effect Rating Scale | Biweekly for 12 weeks | Yes | |
Secondary | 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 | 12 weeks | No |
Secondary | Amino Acid Serum Levels | Glutamate, Glycine, D-serine | 12 weeks | No |
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