NCT00561561

Brief Summary

This study is looking at problems people sometimes have taking in information from their senses. Specifically, we are comparing the way in which people diagnosed with schizophrenia process sound information, compared with people who have never been diagnosed with a psychiatric disorder. When people hear a loud sound they sometimes feel startled, and when they feel startled they usually blink their eyes. However, if they hear a softer sound shortly before the loud one they may not blink their eyes - in other words, the eye-blink response is smaller. When this happens it's called prepulse inhibition of startle. In this study, we want to measure the startle response and prepulse inhibition of startle in individuals diagnosed with schizophrenia versus individuals not diagnosed with schizophrenia. We also want to find out whether people show the same amount of prepulse inhibition of startle as other members of their family.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
531

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jun 2001

Longer than P75 for not_applicable schizophrenia

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

June 1, 2001

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2011

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

10.2 years

First QC Date

November 20, 2007

Last Update Submit

August 5, 2019

Conditions

Keywords

SchizophreniaPrepulse InhibitionAcoustic Startle

Outcome Measures

Primary Outcomes (1)

  • Prepulse inhibition of acoustic startle

    Day 1 Post-intervention

Study Arms (4)

1

EXPERIMENTAL

Subjects with schizophrenia

Behavioral: Acoustic startle testing

2

ACTIVE COMPARATOR

Health controls

Behavioral: Acoustic startle testing

3

ACTIVE COMPARATOR

Family members of subjects with schizophrenia

Behavioral: Acoustic startle testing

4

ACTIVE COMPARATOR

Family members of healthy controls

Behavioral: Acoustic startle testing

Interventions

recording of eyeblink component of acoustic startle reflex with small surface electrodes during presentation of acoustic stimuli through headphones

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Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of a Schizophrenia Spectrum disorder OR no history of Psychiatric Illness

You may not qualify if:

  • History of head injury with loss of consciousness of more than 5 minutes
  • History of neurological disease (ex. meningitis, encephalitis)
  • Drug or alcohol abuse within the last 3 months
  • Hearing loss
  • Non-correctable vision problems
  • Current cancer treatment (radiation or chemotherapy currently ongoing)
  • History of Post Traumatic Stress Disorder
  • Diagnosis of HIV or AIDS
  • Uncontrolled diabetes
  • History of seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Erica Duncan, MD

    Atlanta VA Medical Center, Emory University Dept of Psychiatry & Behavioral Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 21, 2007

Study Start

June 1, 2001

Primary Completion

August 26, 2011

Study Completion

August 26, 2011

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations