- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05617898
Determining the Role of Social Reward Learning in Social Anhedonia (SAMI)
July 21, 2025 updated by: Junghee Lee, University of Alabama at Birmingham
Determining the Role of Social Reward Learning in Social Anhedonia in First-Episode Psychosis Using Motivational Interviewing in a Perturbation-Based Neuroimaging Approach
This is a clinical trial study that aims to evaluate the specificity of the relationship between reduced sensitivity to social reward and social anhedonia at both behavioral and neural levels.
Individuals who recently experienced their first-episode psychosis will be recruited.
Participants will be randomized 1:1 to motivational interviewing or a time- and format-matched control probe.
At pre- and post-probe, participants will perform two social reward learning tasks in the scanner.
With this design feature, we will examine the relationship between sensitivity to social reward and reduced subjective experience of social pleasure at both the behavioral and neural levels.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Junghee Lee, PhD
- Phone Number: 205-934-8205
- Email: jungheelee@uabmc.edu
Study Contact Backup
- Name: Andrew Meddaugh, BA
- Phone Number: 205-934-8203
- Email: ajmeddaugh@uabmc.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Recruiting
- University of Alabama at Birmingham
-
Contact:
- Junghee Lee, PhD
- Phone Number: 205-934-8205
- Email: jungheelee@uabmc.edu
-
Contact:
- Andrew Meddaugh, BA
- Phone Number: 205-934-8203
- Email: ajmeddaugh@uabmc.edu
-
Principal Investigator:
- Junghee Lee, PhD
-
Sub-Investigator:
- Adrienne C Lahti, MD
-
Sub-Investigator:
- Alison Thomas, PhD
-
Sub-Investigator:
- Caitlin W Clevenger, PhD
-
Sub-Investigator:
- Gerhard S Hellemann, PhD
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- University of California Los Angeles
-
Contact:
- Rebecca Zornitsky, MS
- Phone Number: 424-225-1779
- Email: zornitsky@mednet.ucla.edu
-
Contact:
- Joseph Ventura, PhD
- Phone Number: 310-206-3142
- Email: jventura@mednet.ucla.edu
-
Principal Investigator:
- Keith H Nuechterlein, PhD
-
Principal Investigator:
- Michael F Green, PhD
-
Sub-Investigator:
- Joseph Ventura, PhD
-
Sub-Investigator:
- Kenneth Subotnik, PhD
-
Sub-Investigator:
- Amy M Jimenez, PhD
-
Sub-Investigator:
- Lena M Reddy, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18-35 years
- A first episode of a psychotic illness that began within the past three years
- Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
- Taking 2nd generation antipsychotic medications
- Estimated premorbid IQ not less than 70 as assessed with the Wechsler Test of Adult Reading
- Appropriate for scanning (i.e., no pacemaker or metal implants) and expressed willingness to participate in scanning
- Sufficient fluency in English to comprehend testing procedures
- Corrected vision of at least 20/30
Exclusion Criteria:
- No evidence that substance use makes the diagnosis ambiguous (rule out substance-induced psychosis)
- No evidence of moderate or severe alcohol or substance use disorder in the past 3 months
- No clinically significant disease based on medical history (e.g., epilepsy) or significant head injury
- For females: no current pregnancy
- No sedatives or anxiolytics on the day of assessment
- No medication change 3 weeks prior to enrollment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motivational Interview Intervention
This arm involves three 45-minute sessions on motivational interviewing targeting sensitivity to social reward.
|
Three motivational interviewing sessions will target sensitivity to social reward, including subjective evaluation of social interaction, socially rewarding stimuli, and events (e.g., interactions with others, feedback from others).
|
|
Active Comparator: Active Control Intervention
This arm involves three 45-minute sessions on didactic training on nutrition.
|
The Nutrition didactic training will ask participants to discuss pros and cons of healthy eating habits and how to improve their current eating habits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response Bias
Time Frame: 3 weeks
|
Response bias is defined as the likelihood of making one response, such as the frequently rewarded stimulus, more than the other response during the perceptual social reward learning task
|
3 weeks
|
|
the number of optimal response
Time Frame: 3 weeks
|
The number of optimal response is defined as the number of responses choosing a stimuli with optimal outcomes (e.g., choosing a good over a neutral machine or choosing a neutral over a bad machine) during the inductive social reward learning task.
|
3 weeks
|
|
fMRI activation levels
Time Frame: 3 weeks
|
fMRI activation is defined as beta weights from general linear model from key regions of interests including the ventromedial prefrontal cortex, dorsal anterior cingulate cortex and ventral striatum during the perceptual social reward learning task and the inductive social reward learning task.
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2023
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Study Registration Dates
First Submitted
October 31, 2022
First Submitted That Met QC Criteria
November 7, 2022
First Posted (Actual)
November 16, 2022
Study Record Updates
Last Update Posted (Actual)
July 24, 2025
Last Update Submitted That Met QC Criteria
July 21, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300009711
- 1R01MH129351-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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