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Early-onset SchizophreniaNCT03068793

Reward Processing in Mental Illness

An observational study of Early-onset Schizophrenia, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Early-onset Schizophrenia
What is being tested?
Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)
How many people
80 participants
Where
1 siteUnited States
Study dates
1 Oct 2013to 30 Jun 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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:
  • 1. Patients must be diagnosed with DSM-IV schizophrenia, schizophreniform, or schizoaffective disorder based on a SCID-P interview.
  • Depression subjects:
  • 1. Patients must be diagnosed with DSM-V Major Depressive Disorder based on a SCID-P interview.
  • Post Traumatic Stress Disorder subjects:
Show all 11Show fewer
  • 1. Patients must be diagnosed with DSM-V Post Traumatic Stress Disorder based on a SCID-P interview.
  • Gambling Disorder subjects:
  • 1. Patients must be diagnosed with DSM-V Gambling Disorder based on a SCID-P interview.
  • Comparison subjects:
  • 1. Control participants must not have past or present Axis I diagnosis as determined by the SCID-NP.

Who cannot join

  • 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.
Show all 9Show fewer
  • Non-English speaking.
  • Comparison subjects:
  • 1. Any first-degree relative with schizophrenia or bipolar disorder.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • San Francisco VA Medical Center

    San Francisco, California, 94121

Other trials in United States

About this study

Official title: Multimodal Neural Investigation of Reward Processing in Mental Illness

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.

Read the detailed description

This experiment takes place over the course of two or three days. On each visit day, the experiment will involve a brief interview session, electroencephalography (EEG) recording,and/or a magnetic resonance imaging (MRI).

Screening tests or procedures include:

  • If you are female of child bearing potential, you must complete a urine pregnancy test for the MRI procedure
  • You will be asked a series of questions about your mental health and your background

If the screening exam shows that you can be in the main part of the study and you choose to continue, these are the tests and procedures that you would complete on one or two test days:

  • EEG recording: In this procedure, the researcher will assess your brain function while you perform simple computer-based tasks. The computer tasks involve presentation of pictures to which you respond by pressing a button. You will be given clear instructions and a chance to practice before each task. While you are performing these tasks, we will record the weak electrical signals produced by your brain, or "brain waves", using a technique called electroencephalography (EEG).
  • In order to record your EEG, sensors (small plastic discs) will be attached to specific locations on your scalp. Your scalp will be gently scrubbed before the sensors are attached. The sensors are held in place on your scalp using a nylon cap that fits snugly on your head. Sensors will also be attached above and below your eyes and will record your eye movements. It will take approximately one hour to attach the sensors. The entire EEG will take approximately 2 hours.
  • Before you take part in the EEG session, please make sure to wash your hair and scalp. Do not use conditioner or a 2-in-1 shampoo/conditioner. Your hair should be dry before your arrival. We ask this in order to make the set-up process go more smoothly.
  • MRI: In the fMRI procedure, we will use a magnet to measure blood flow to your brain while you do different cognitive tasks. You will be asked to lie down on a platform that can be slid into the middle of the magnet. A plastic MRI imaging coil will be placed around your head. You will not come into contact with the coil during the experiment. Foam pads will be placed around your head to limit head movement during the experiment. We will then slide you into the magnet. At different points during the experiment, you will be asked to do the same tasks you did in the training session prior to the scan. During the scan, you will be asked to either lie still and rest, or do some tasks similar to those you completed during your EEG. The entire MRI will take approximately two hours.
  • If the researchers feel as though the quality of data collected by the scanner can be improved, you may be asked to return for an additional scan session.
  • Brief interview session: There will be a series of questions about your education, smoking status, and economic background. You will also be given a list of words to read to the researcher. If you are a patient diagnosed with one of the above-mentioned psychiatric disorders, you will be asked to participate in an additional interview, lasting about one hour, focusing on how you have been feeling recently.
Being tested
Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)Diagnostic test

    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.

Study groups in NCT03068793
Study groupRoleWhat they receive
Patients with Recent Onset SchizophreniaIndividuals 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.
Receives: Diagnostic Test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)
Patients with Major Depressive DisorderIndividuals 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.
Receives: Diagnostic Test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)
Patients with Gambling DisorderIndividuals 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.
Receives: Diagnostic Test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)
Patients with Post Traumatic Stress DisorderIndividuals 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.
Receives: Diagnostic Test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)
Healthy ControlsIndividuals 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.
Receives: Diagnostic Test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EEG

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

    Measured: At time of visit

  2. MRI

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

    Measured: At time of visit

  3. Reward Processing Tasks

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

    Measured: At time of visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2017
  2. Study start1 Oct 2013
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03068793
Sponsor's protocol ID
IK2CX001028
Status last verified
Sep 2026
First submitted
27 Feb 2017
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fenton WS, McGlashan TH. Natural history of schizophrenia subtypes. II. Positive and negative symptoms and long-term course. Arch Gen Psychiatry. 1991 Nov;48(11):978-86. doi: 10.1001/archpsyc.1991.01810350018003.

    PubMed 1747021
  • Bleuler, E. Dementia Praecox or the Group of Schizophrenias. (1911) (International Universities Press, New York, NY, Translated by J. Zinkin, 1950).

  • Milev P, Ho BC, Arndt S, Andreasen NC. Predictive values of neurocognition and negative symptoms on functional outcome in schizophrenia: a longitudinal first-episode study with 7-year follow-up. Am J Psychiatry. 2005 Mar;162(3):495-506. doi: 10.1176/appi.ajp.162.3.495.

    PubMed 15741466
  • Rabinowitz J, Levine SZ, Garibaldi G, Bugarski-Kirola D, Berardo CG, Kapur S. Negative symptoms have greater impact on functioning than positive symptoms in schizophrenia: analysis of CATIE data. Schizophr Res. 2012 May;137(1-3):147-50. doi: 10.1016/j.schres.2012.01.015. Epub 2012 Feb 6.

    PubMed 22316568
  • Kirkpatrick B, Fenton WS, Carpenter WT Jr, Marder SR. The NIMH-MATRICS consensus statement on negative symptoms. Schizophr Bull. 2006 Apr;32(2):214-9. doi: 10.1093/schbul/sbj053. Epub 2006 Feb 15. No abstract available.

    PubMed 16481659
  • Gold JM, Waltz JA, Matveeva TM, Kasanova Z, Strauss GP, Herbener ES, Collins AG, Frank MJ. Negative symptoms and the failure to represent the expected reward value of actions: behavioral and computational modeling evidence. Arch Gen Psychiatry. 2012 Feb;69(2):129-38. doi: 10.1001/archgenpsychiatry.2011.1269.

    PubMed 22310503
  • Gold JM, Waltz JA, Prentice KJ, Morris SE, Heerey EA. Reward processing in schizophrenia: a deficit in the representation of value. Schizophr Bull. 2008 Sep;34(5):835-47. doi: 10.1093/schbul/sbn068. Epub 2008 Jun 30.

    PubMed 18591195
  • Heinz A, Schlagenhauf F. Dopaminergic dysfunction in schizophrenia: salience attribution revisited. Schizophr Bull. 2010 May;36(3):472-85. doi: 10.1093/schbul/sbq031. Epub 2010 May 7.

    PubMed 20453041
  • Waltz JA, Frank MJ, Robinson BM, Gold JM. Selective reinforcement learning deficits in schizophrenia support predictions from computational models of striatal-cortical dysfunction. Biol Psychiatry. 2007 Oct 1;62(7):756-64. doi: 10.1016/j.biopsych.2006.09.042. Epub 2007 Feb 14.

    PubMed 17300757
  • Barch DM, Dowd EC. Goal representations and motivational drive in schizophrenia: the role of prefrontal-striatal interactions. Schizophr Bull. 2010 Sep;36(5):919-34. doi: 10.1093/schbul/sbq068. Epub 2010 Jun 21.

    PubMed 20566491
  • Haber SN, Knutson B. The reward circuit: linking primate anatomy and human imaging. Neuropsychopharmacology. 2010 Jan;35(1):4-26. doi: 10.1038/npp.2009.129.

    PubMed 19812543
  • Maldjian JA, Laurienti PJ, Kraft RA, Burdette JH. An automated method for neuroanatomic and cytoarchitectonic atlas-based interrogation of fMRI data sets. Neuroimage. 2003 Jul;19(3):1233-9. doi: 10.1016/s1053-8119(03)00169-1.

    PubMed 12880848
  • Schultz W. Behavioral theories and the neurophysiology of reward. Annu Rev Psychol. 2006;57:87-115. doi: 10.1146/annurev.psych.56.091103.070229.

    PubMed 16318590
  • Schultz W, Dayan P, Montague PR. A neural substrate of prediction and reward. Science. 1997 Mar 14;275(5306):1593-9. doi: 10.1126/science.275.5306.1593.

    PubMed 9054347
  • Berridge KC. The debate over dopamine's role in reward: the case for incentive salience. Psychopharmacology (Berl). 2007 Apr;191(3):391-431. doi: 10.1007/s00213-006-0578-x. Epub 2006 Oct 27.

    PubMed 17072591

Questions about this trial

What is this clinical trial studying?

An observational study of Early-onset Schizophrenia, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EEG (time frame: At time of visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03068793, which also lists 66 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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