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

Schizophrenia Clinical Trial

Official title:

D-Serine Adjuvant Pharmacotherapy for the Treatment of Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00138775
• Other study ID #: SHEBA-03-3093-MW-CTIL
• Status: Recruiting
• Phase: Phase 2
• First received: August 28, 2005
• Last updated: December 24, 2006
• Start date: October 2004
• Est. completion date: October 2007

Study information

• Verified date: October 2006
• Source: Sheba Medical Center
• Contact: Mark Weiser, MD
• Phone: ++972-352-6666575
• Email: mweiser[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• D-serine

Locations

Country	Name	City	State
Israel	Ha-Emek Medical Center	Afula
Israel	Mazra Mental Health Center	Akko
Israel	Abarbanel Mental Health Center	Bat Yam
Israel	Beer-Yaacov Mental Health Center	Beer-Yaacov
Israel	Shalvata Mental Health Center	Hod Hasharon
Israel	Kfar Shaul Psychiatric Hospital	Jerusalem
Israel	The Sarah Herzog Memorial Hospital	Jerusalem
Israel	Nes-Ziona Mental Health Center	Nes Ziona
Israel	Lev Hasharon Mental Health Center	Pardesiyya
Israel	Geha Mental Health Center	Petah Tiqwa
Israel	Sheba Medical Center	Ramat-Gan
Israel	Shaar Menashe Mental Health Center	Shaar Menashe
Israel	Jaffa Mental Health Center	Tel Aviv
Israel	Maccabi Mental Health Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Stanley Medical Research Institute

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SANS - Scale for the Assessment of Negative Symptoms - weeks 0, 8 and 16
Primary	Measurement and Treatment Research for Cognition in Schizophrenia (MATRICS) battery - visit weeks 0, 8 and 16
Secondary	Positive and Negative Syndrome Scale of Schizophrenia (PANSS) positive, negative, general and total score - weeks 0, 8 and 16
Secondary	Simpson-Angus Scale (SAS) total score - weeks 0, 8 and 16
Secondary	Clinical Global Impressions (CGI) score - weeks 0, 8 and 16
Secondary	Calgary Depression Scale for Schizophrenia (CDSS) score - weeks 0, 8 and 16
Secondary	Side effect check list