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

D-Serine Adjuvant Pharmacotherapy for the Treatment of Schizophrenia

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00138775

Enrollment

200

Registered

2005-08-30

Start date

2004-10-31

Completion date

2007-10-31

Last updated

2006-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia

Keywords

D-serine, Negative symptoms, Cognition, Schizophrenia, Amino acid

Brief summary

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.

Interventions

DRUGD-serine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Israel

Contacts

Primary ContactMark Weiser, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026