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

Phase 2

• Conditions: Schizophrenia; Schizoaffective Disorder

• Registration Number: NCT00138775
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-08-28
• Study First Submitted QC: 2005-08-28
• Study First Posted: 2005-08-30
• Status Verified: 2006-10
• Last Update Submitted: 2006-12-24
• Last Update Posted: 2006-12-27
• Study Completion: 2007-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (14)

Shalvata Mental Health Center; 🇮🇱 Hod Hasharon, Israel

Shaar Menashe Mental Health Center; 🇮🇱 Shaar Menashe, Israel

Sheba Medical Center; 🇮🇱 Ramat-Gan, Israel

Ha-Emek Medical Center; 🇮🇱 Afula, Israel

Abarbanel Mental Health Center; 🇮🇱 Bat Yam, Israel

The Sarah Herzog Memorial Hospital; 🇮🇱 Jerusalem, Israel

Maccabi Mental Health Center; 🇮🇱 Tel Aviv, Israel

Beer-Yaacov Mental Health Center; 🇮🇱 Beer-Yaacov, Israel

Geha Mental Health Center; 🇮🇱 Petah Tiqwa, Israel

Mazra Mental Health Center; 🇮🇱 Akko, Israel

Nes-Ziona Mental Health Center; 🇮🇱 Nes Ziona, Israel

Kfar Shaul Psychiatric Hospital; 🇮🇱 Jerusalem, Israel

Jaffa Mental Health Center; 🇮🇱 Tel Aviv, Israel

Lev Hasharon Mental Health Center; 🇮🇱 Pardesiyya, Israel