NCT00817336

Brief Summary

N-methyl-D-aspartate (NMDA)-type glutamate receptors are thought to play a pivotal role in neurocognitive dysfunction associated with schizophrenia. Further, several novel glutamate-based classes of compound are presently in development as potential novel treatments for persistent negative and cognitive symptoms. The study will assess effectiveness of a NMDA-based intervention on biomarkers related to schizophrenia as a mechanism for developing appropriate outcome batteries for future trials of novel compounds.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2 schizophrenia

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

August 2, 2017

Completed
Last Updated

August 2, 2017

Status Verified

July 1, 2017

Enrollment Period

2.1 years

First QC Date

January 5, 2009

Results QC Date

December 15, 2016

Last Update Submit

July 7, 2017

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

biomarkerEEGschizophreniaNMDAD-serine

Outcome Measures

Primary Outcomes (2)

  • PANSS Total

    Positive and Negative Symptom Scale (PANSS) range 30-210

    6 weeks

  • MMN Amplitude

    Final MMN amplitude

    6 weeks

Secondary Outcomes (2)

  • MATRICS

    6 weeks

  • Visual P1

    6 weeks

Study Arms (2)

D-serine

EXPERIMENTAL

60 mg/kg/day

Drug: D Serine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

D SerineDRUG

60 mg/kg/day

D-serine
PlaceboDRUG

oral

Placebo

Eligibility Criteria

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

You may qualify if:

  • Age 18-64
  • SCID diagnosis of Schizophrenia or Schizoaffective Disorder.
  • PANSS 3 factor negative symptom (screening and baseline visit 1 and visit 3) score of \>20 and PANSS total score between 60-110. Any degree of positive symptoms is acceptable but the total PANSS score must not exceed 110.
  • SAS total score less than or equal to 12 and a Calgary Depression Inventory total score less than or equal to 10 and suicide (item 8) less than moderate (\<2).
  • Two consecutive CGI ratings at screening and baseline (visit 1 and 3) with no change in score.
  • Estimated Glomerular Filtration Rate (GFR)(a measure of renal function) greater than or equal to 60.

You may not qualify if:

  • Organic brain disorder, including epilepsy; mental retardation; or a medical condition whose pathology or treatment would likely alter the presentation or treatment of schizophrenia or significantly increase the risk associated with any of the proposed treatments
  • Current DSM-IV diagnosis of drug/alcohol abuse in last month and current DSM-IV diagnosis of drug/alcohol dependence in last 6 months
  • Pregnant female patients
  • Impaired renal function
  • Significant extrapyramidal symptoms (as reflected by a total score of 10 or above on the SAS scale), and depressive symptoms (as reflected by a score of 10 or above on the Calgary Depression Scale for Schizophrenia)
  • Patients who are unable to or unwilling to participate in the Cognitive assessment (MATRICS) and the electrophysiology tasks .
  • Patients on clozapine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nathan Kline Institute

Orangeburg, New York, 10962, United States

Location

Related Publications (1)

  • Kantrowitz JT, Epstein ML, Lee M, Lehrfeld N, Nolan KA, Shope C, Petkova E, Silipo G, Javitt DC. Improvement in mismatch negativity generation during d-serine treatment in schizophrenia: Correlation with symptoms. Schizophr Res. 2018 Jan;191:70-79. doi: 10.1016/j.schres.2017.02.027. Epub 2017 Mar 18.

    PMID: 28318835DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Joshua Kantrowitz
Organization
Nathan Kline Institute
jk3380@cumc.columbia.edu
646-774-6738

Study Officials

  • Daniel C Javitt, MD, PhD

    New York University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2009

First Posted

January 6, 2009

Study Start

June 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 2, 2017

Results First Posted

August 2, 2017

Record last verified: 2017-07

Locations

US(1)