NCT03068793

Brief Summary

The purpose of this study is to examine the nature of reward processing dysfunctions in schizophrenia using neuroimaging techniques that capture in vivo brain functioning, such as EEG and fMRI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 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, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

5.7 years

First QC Date

February 27, 2017

Last Update Submit

July 12, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • EEG

    Electroencephalography, measures signals from the brain while participants conduct specific tasks that measure memory and attention.

    At time of visit

  • MRI

    Magnetic Resonance Imaging, measures activity in, and takes detailed pictures of the brain while participants conduct specific tasks that measure memory and attention.

    At time of visit

  • Reward Processing Tasks

    A slot machine task where participants can win real money while participating in an EEG and MRI

    At time of visit

Study Arms (5)

Patients with Recent Onset Schizophrenia

Individuals who have been diagnosed with Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder within the past five years and meet our research criteria for symptoms indicative of these diseases within the past five years.

Diagnostic Test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)

Patients with Major Depressive Disorder

Individuals who have been diagnosed with Major Depressive Disorder within the past five years and meet our research criteria for symptoms indicative of this disease within the past five years.

Diagnostic Test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)

Patients with Gambling Disorder

Individuals who have been diagnosed with Gambling Disorder within the past five years and meet our research criteria for symptoms indicative of this disease within the past five years.

Diagnostic Test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)

Patients with Post Traumatic Stress Disorder

Individuals who have been diagnosed with Post Traumatic Stress Disorder within the past five years and meet our research criteria for symptoms indicative of this disease within the past five years.

Diagnostic Test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)

Healthy Controls

Individuals who have not met criteria for a psychiatric, mood, or gambling disorder within their lifetime according to our research criteria for symptoms indicative of a psychiatric, mood, or gambling disorder.

Diagnostic Test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)

Interventions

We will use these techniques combined with tests of reward anticipation and clinical interviews to explore connections between these measures and activity in the brain in patients with a diagnosis of schizophrenia, major depressive disorder, gambling disorder, or post traumatic stress disorder and healthy controls.

Healthy ControlsPatients with Gambling DisorderPatients with Major Depressive DisorderPatients with Post Traumatic Stress DisorderPatients with Recent Onset Schizophrenia

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder within the past 5 years and meet our research criteria of symptoms indicative of a diagnosis of schizophrenia within their lifetime are eligible for this study. Patients who have been diagnosed with Major Depressive Disorder, Post Traumatic Stress Disorder, and Gambling Disorder within the past 5 years and meet our research criteria of symptoms indicative of a diagnosis of one of these disorders within their lifetime are also eligible for this study. Healthy controls who have never met criteria for a psychiatric disorder and meet our research criteria will also be included in this study.

You may qualify if:

  • The subject population will include 18 to 30 year old participants of any gender, race, and ethnicity. All subjects will be able to speak and understand English.
  • Schizophrenia subjects:
  • \. Patients must be diagnosed with DSM-IV schizophrenia, schizophreniform, or schizoaffective disorder based on a SCID-P interview.
  • Depression subjects:
  • \. Patients must be diagnosed with DSM-V Major Depressive Disorder based on a SCID-P interview.
  • Post Traumatic Stress Disorder subjects:
  • \. Patients must be diagnosed with DSM-V Post Traumatic Stress Disorder based on a SCID-P interview.
  • Gambling Disorder subjects:
  • \. Patients must be diagnosed with DSM-V Gambling Disorder based on a SCID-P interview.
  • Comparison subjects:
  • \. Control participants must not have past or present Axis I diagnosis as determined by the SCID-NP.

You may not qualify if:

  • All subjects:
  • A hearing deficit greater than 40dB in both ears detected during the hearing test
  • Substance dependence, as per clinical judgment, in the past 1 year (except caffeine and nicotine)
  • A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic or neurological
  • History of head injury with loss of consciousness greater than 15 minutes
  • Any other condition or medication, which in the opinion of the investigator would preclude participation in the study.
  • Non-English speaking.
  • Comparison subjects:
  • \. Any first-degree relative with schizophrenia or bipolar disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

Related Publications (66)

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MeSH Terms

Interventions

ElectroencephalographyMagnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisTomographyDiagnostic Imaging

Study Officials

  • Susanna Fryer, PhD

    San Francisco VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor in Residence

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 3, 2017

Study Start

October 1, 2013

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations