NCT01191827

Brief Summary

This study aims to determine how clozapine treatment improves neuronal measures of sensory gating in subjects with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 31, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

May 15, 2015

Completed
Last Updated

May 15, 2015

Status Verified

May 1, 2015

Enrollment Period

3.2 years

First QC Date

August 27, 2010

Results QC Date

December 23, 2014

Last Update Submit

May 12, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Neuronal Response During Sensory Gating

    Neuronal response (blood oxygenation level dependent functional magnetic resonance imaging signal, relative to the global mean) during sensory gating. Sensory gating is defined as the process of filtering out unnecessary environmental stimuli.

    Immediate

Study Arms (2)

risperidone

clozapine

Patients with schizophrenia treated with clozapine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects with schizophrenia

You may qualify if:

  • Diagnosis of schizophrenia
  • age 18-60 yrs

You may not qualify if:

  • claustrophobia
  • weight \> 250 lbs
  • metal in body other than dental fillings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Research Biologist
Organization
Denver VA Medical Center

Study Officials

  • Jason R. Tregellas, PhD

    VA Eastern Colorado Health Care System, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2010

First Posted

August 31, 2010

Study Start

October 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 15, 2015

Results First Posted

May 15, 2015

Record last verified: 2015-05

Locations