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

Sponsor

Sheba Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00138775

Collaborator

Stanley Medical Research Institute (Other)

200

Enrollment

Locations

Duration (Months)

14.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizoaffective Disorder	Drug: D-serine	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

D-Serine Adjuvant Pharmacotherapy for the Treatment of Schizophrenia

Study Start Date :

Oct 1, 2004

Study Completion Date :

Oct 1, 2007

Outcome Measures

Primary Outcome Measures

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

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Ha-Emek Medical Center	Afula	Israel
2	Mazra Mental Health Center	Akko	Israel
3	Abarbanel Mental Health Center	Bat Yam	Israel
4	Beer-Yaacov Mental Health Center	Beer-Yaacov	Israel
5	Shalvata Mental Health Center	Hod Hasharon	Israel
6	Kfar Shaul Psychiatric Hospital	Jerusalem	Israel
7	The Sarah Herzog Memorial Hospital	Jerusalem	Israel
8	Nes-Ziona Mental Health Center	Nes Ziona	Israel
9	Lev Hasharon Mental Health Center	Pardesiyya	Israel
10	Geha Mental Health Center	Petah Tiqwa	Israel
11	Sheba Medical Center	Ramat-Gan	Israel
12	Shaar Menashe Mental Health Center	Shaar Menashe	Israel
13	Jaffa Mental Health Center	Tel Aviv	Israel
14	Maccabi Mental Health Center	Tel Aviv	Israel