NCT00573300

Brief Summary

In this pilot study, the investigators propose to characterize the pattern of activation of the kynurenine pathway of tryptophan metabolism in peripheral macrophages of patients with schizophrenia. To do this, the investigators will measure the gene expression of several major enzymes in this pathway in macrophages, including the key enzyme involved in tryptophan to kynurenine metabolism, IDO, by means of quantitative reverse-transcription polymerase chain reaction (RT-PCR). The focus on enzyme mRNA expression as opposed to serum or cerebrospinal fluid levels of metabolites provides a possibly more sensitive characterization of the activation of this metabolic pathway.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

August 12, 2009

Status Verified

August 1, 2009

Enrollment Period

3.3 years

First QC Date

December 13, 2007

Last Update Submit

August 11, 2009

Conditions

Schizophrenia

Keywords

SchizophreniaImmune SystemKynurenatetryptophan metabolismNMDA receptorindolamine 2,3-deoxygenase (IDO)

Study Arms (2)

Schizophrenia

Schizophrenia Patients

Procedure: Phlebotomy

Healthy Controls

Healthy Controls

Procedure: Phlebotomy

Interventions

PhlebotomyPROCEDURE

Single blood draw

Healthy ControlsSchizophrenia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Schizophrenia patients

You may qualify if:

  • Diagnosis of Schizophrenia, any subtype or schizoaffective disorder
  • Ages 18-65 years
  • Males or females
  • English speaking with ability to complete symptom ratings
  • Ability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freedom Trail Clinic

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Schizophrenia

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Oliver Freudenreich, M.D.

    North Suffolk Mental Health Association

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 14, 2007

Study Start

January 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

August 12, 2009

Record last verified: 2009-08

Locations

US(1)