NCT00138775

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2 schizophrenia

Timeline
Completed

Started Oct 2004

Typical duration for phase_2 schizophrenia

Geographic Reach
1 country

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

December 27, 2006

Status Verified

October 1, 2006

First QC Date

August 28, 2005

Last Update Submit

December 24, 2006

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

D-serineNegative symptomsCognitionSchizophreniaAmino acid

Outcome Measures

Primary Outcomes (2)

  • 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 (5)

  • 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

Interventions

D-serineDRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Mazra Mental Health Center

Acre, Israel

RECRUITING

Ha-Emek Medical Center

Afula, Israel

NOT YET RECRUITING

Abarbanel Mental Health Center

Bat Yam, Israel

RECRUITING

Beer-Yaacov Mental Health Center

Beer-Yaacov, Israel

RECRUITING

Shalvata Mental Health Center

Hod HaSharon, Israel

RECRUITING

Kfar Shaul Psychiatric Hospital

Jerusalem, Israel

RECRUITING

The Sarah Herzog Memorial Hospital

Jerusalem, Israel

RECRUITING

Nes-Ziona Mental Health Center

Ness Ziona, Israel

RECRUITING

Lev Hasharon Mental Health Center

Pardesiyya, Israel

RECRUITING

Geha Mental Health Center

Petah Tikva, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Shaar Menashe Mental Health Center

Shaar Menashe, Israel

NOT YET RECRUITING

Jaffa Mental Health Center

Tel Aviv, Israel

RECRUITING

Maccabi Mental Health Center

Tel Aviv, Israel

NOT YET RECRUITING

Related Publications (1)

  • Weiser M, Heresco-Levy U, Davidson M, Javitt DC, Werbeloff N, Gershon AA, Abramovich Y, Amital D, Doron A, Konas S, Levkovitz Y, Liba D, Teitelbaum A, Mashiach M, Zimmerman Y. A multicenter, add-on randomized controlled trial of low-dose d-serine for negative and cognitive symptoms of schizophrenia. J Clin Psychiatry. 2012 Jun;73(6):e728-34. doi: 10.4088/JCP.11m07031.

    PMID: 22795211DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Mark Weiser, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Weiser, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 28, 2005

First Posted

August 30, 2005

Study Start

October 1, 2004

Study Completion

October 1, 2007

Last Updated

December 27, 2006

Record last verified: 2006-10

Locations

IL(14)