Clinical trial NCT03068793: Reward Processing in Mental Illness
Official title: Multimodal Neural Investigation of Reward Processing in Mental Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early-onset Schizophrenia
Lead sponsor: San Francisco Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2017-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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:

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.

Exclusion Criteria:

* All subjects:

  1. A hearing deficit greater than 40dB in both ears detected during the hearing test
  2. Substance dependence, as per clinical judgment, in the past 1 year (except caffeine and nicotine)
  3. A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic or neurological
  4. History of head injury with loss of consciousness greater than 15 minutes
  5. Any other condition or medication, which in the opinion of the investigator would preclude participation in the study.
  6. Non-English speaking.

Comparison subjects:

1. Any first-degree relative with schizophrenia or bipolar disorder.

Primary outcomes:
measure: EEG
timeFrame: At time of visit
measure: MRI
timeFrame: At time of visit
measure: Reward Processing Tasks
timeFrame: At time of visit
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: San Francisco VA Medical Center
name: Susanna Fryer, PhD
role: PRINCIPAL_INVESTIGATOR
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