Israel Multicenter D-Serine Study (IMSER) for the Treatment of Schizophrenia

Sheba Medical Center200 enrolled

Overview

The goal of the present study is to evaluate the effect of D-serine, added to antipsychotic treatment, on negative and cognitive symptoms in schizophrenia. The investigators are hypothesizing that D-serine will improve cognitive functioning and negative symptoms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Schizophrenia Schizoaffective Disorder

Interventions

D-serineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) diagnosis of schizophrenia and\\or schizoaffective disorder. * Age between 18 to 64. * PANSS negative symptom score higher than 19. * SAS total score lower than 12. * CDSS suicidal risk lower than 2 Exclusion Criteria: * Epilepsy * Meets DSM-IV criteria for mental retardation. * Medical condition which confounds presentation or treatment (e.g. uncontrolled diabetes mellitus, history of kidney stones, acute drug toxicity, dementia, delirium, stroke, etc.) * Meets DSM-IV criteria for alcohol or drug dependence in last 6 months. * Meets DSM-IV criteria for alcohol or drug abuse in last one month. * Treatment with clozapine. * Current positive pregnancy test or not using acceptable method of birth control. * Meets DSM-IV criteria for current anxiety or mood disorders

Locations (14)

Mazra Mental Health Center

Acre, Israel

RECRUITING

Ha-Emek Medical Center

Afula, Israel

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

SANS - Scale for the Assessment of Negative Symptoms - weeks 0, 8 and 16

Measurement and Treatment Research for Cognition in Schizophrenia (MATRICS) battery - visit weeks 0, 8 and 16

Secondary Outcomes

Positive and Negative Syndrome Scale of Schizophrenia (PANSS) positive, negative, general and total score - weeks 0, 8 and 16

Simpson-Angus Scale (SAS) total score - weeks 0, 8 and 16

Clinical Global Impressions (CGI) score - weeks 0, 8 and 16

Calgary Depression Scale for Schizophrenia (CDSS) score - weeks 0, 8 and 16

Side effect check list

Central Contacts

Mark Weiser, MD

CONTACT

++972-352-6666575 mweiser@netvision.net.il

Data from ClinicalTrials.gov

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