NCT00322023

Brief Summary

This study will determine whether increasing D-serine within the body will improve negative symptoms and cognitive impairments in people with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
Completed

Started Mar 2006

Typical duration for phase_2 schizophrenia

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
11.8 years until next milestone

Results Posted

Study results publicly available

October 5, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

2.8 years

First QC Date

May 2, 2006

Results QC Date

May 29, 2012

Last Update Submit

September 11, 2020

Conditions

Schizophrenia

Keywords

Negative symptomsNMDAGlutamateGlycine

Outcome Measures

Primary Outcomes (1)

  • Renal Safety Measures

    number of renal adverse events (serum and urinalysis)

    Measured at Week 4

Secondary Outcomes (2)

  • Positive and Negative Symptoms Scale (PANSS)

    Measured at Week 4

  • Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Battery

    Measured at Week 4

Study Arms (3)

D-serine 30 mg/kg

EXPERIMENTAL

D-serine 30 mg/kg

Drug: D-serine

D-serine 60 mg/kg

EXPERIMENTAL

D-serine 60 mg/kg

Drug: D-serine

D-serine 120 mg/kg

EXPERIMENTAL

D-serine 120 mg/kg

Drug: D-serine

Interventions

D-serineDRUG

D-serine at following dose levels: 30 mg/kg, 60 mg/kg, and 120 mg/kg. PK/PD studies done at day 1. Medication will be administered as powder dissolved in liquid given in two divided doses daily for 4 weeks.

D-serine 120 mg/kgD-serine 30 mg/kgD-serine 60 mg/kg

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Structured Clinical Interview for DSM-III-R diagnosis of schizophrenia or schizoaffective disorder
  • PANSS total score between 60 and 110
  • Simpson-Angus Scale total score of 12 or less
  • Calgary Depression Inventory total score of 10 and suicide score less than 2
  • No change in Clinical Global Impressions (CGI) Scale score prior to study entry
  • Chlorpromazine (CPZ) equivalent of 1500 or less
  • Willing to use an effective form of birth control throughout the study if sexually active

You may not qualify if:

  • High extrapyramidal symptom (EPS) levels
  • Began, discontinued, or adjusted psychotropic medication within 2 weeks of study entry
  • Taking investigational medication within 2 weeks of study entry
  • Contraindication to study medication
  • Serious or unstable medical illness
  • Pregnant or breastfeeding
  • Alcohol or drug abuse within 6 months of study entry
  • Diagnosed with neurodegenerative disease or a seizure disorder
  • History of a kidney impairment
  • Currently taking clozapine
  • Currently taking more than two antipsychotic medications
  • Currently taking stimulants or cholinesterase inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yale University School of Medicine

New Haven, Connecticut, 06512, United States

Location

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

The Nathan S. Kline Institute for Psychiatric Research

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

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Limitations and Caveats

Open Label

Results Point of Contact

Title
Dr. Daniel Javitt
Organization
Nathan Kline Institute
javitt@nki.rfmh.org
845-398-6534

Study Officials

  • Daniel C. Javitt, MD, PhD

    Nathan Kline Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 2, 2006

First Posted

May 4, 2006

Study Start

March 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

October 5, 2020

Results First Posted

October 5, 2020

Record last verified: 2020-09

Locations

US(3)