Cognitive Strategies in Early Psychosis 1

NCT07231497 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: STUDY00025500P50MH119569
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. The investigators will ask people who do not have psychosis to take a single dose of modafinil and then complete some brain games on the computer that measure decision making. They hope to improve our understanding of psychosis to help people in the future. The main research questions are: Does a single dose of modafinil change how people play the brain games? Does a single dose of modafinil change brain activity? Participants will: Complete an interview and self-report questionnaires. Complete safety screening activities, like a blood draw, a urine drug test, and an alcohol breathalyzer test. Take a single dose of modafinil. Complete brain games while wearing an electroencephalography (EEG) cap, before and after taking the single dose of modafinil. EEG measures electrical activity in the brain.

Conditions

Cognition; Healthy Participants

Keywords

Cognition; Decision making; Electroencephalography (EEG); Psychosis

Outcome Measures

Primary Outcomes (17)

• Test My Brain - Digit Symbol Coding

  A computerized cognitive assessment measuring processing speed. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.

  Baseline

• Test My Brain - Digit Symbol Coding

  A computerized cognitive assessment measuring processing speed. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.

  Day 7 (EEG + Modafinil Appointment)

• Test My Brain - Verbal Paired Associates Memory

  A computerized cognitive assessment measuring verbal memory. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.

  Baseline

• Test My Brain - Verbal Paired Associates Memory

  A computerized cognitive assessment measuring verbal memory. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.

  Day 7 (EEG + Modafinil Appointment)

• Test My Brain - Matrix Reasoning

  A computerized cognitive assessment measuring problem solving. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.

  Baseline

• Test My Brain - Matrix Reasoning

  A computerized cognitive assessment measuring problem solving. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.

  Day 7 (EEG + Modafinil Appointment)

• Test My Brain - Multiracial Emotion Identification

  A computerized cognitive assessment measuring social cognition and emotion recognition skills. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.

  Baseline

• Test My Brain - Multiracial Emotion Identification

  A computerized cognitive assessment measuring social cognition and emotion recognition skills. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.

  Day 7 (EEG + Modafinil Appointment)

• Electroencaphalography (EEG) - Resting alpha synchrony

  The EEG will measure resting state alpha synchrony in the brain. The primary outcome will be differences in EEG activity before and after modafinil administration.

  Day 7 (EEG + Modafinil Appointment)

• Electroencaphalography (EEG) - Oscillatory frontal gamma synchrony

  The EEG will measure oscillatory frontal gamma synchrony in the brain. The primary outcome will be differences in EEG activity before and after modafinil administration

  Day 7 (EEG + Modafinil Appointment)

• Electroencaphalography (EEG) - Task-related reward positivity/P900

  The EEG will measure task-related reward positivity/P900 activity in the brain. The primary outcome will be differences in EEG activity before and after modafinil administration

  Day 7 (EEG + Modafinil Appointment)

• Electroencaphalography (EEG) - N1 amplitude

  The EEG will measure N1 amplitude in the brain. The primary outcome will be differences in EEG activity before and after modafinil administration

  Day 7 (EEG + Modafinil Appointment)

• Dot Pattern Expectancy variation (TOPX) Task - Accuracy

  The TOPX task consists of a series of pattern sequences. One pattern is designated the "A" cue, and another the "X" cue, which requires one response (AX, 60-70% of trials, e.g. respond with the left button), while other sequences require a different response (AY or BX, 12-15% of trials each, or BY, 6-10% of trials, e.g. respond with the right button). Given the strong expectation that X's evokes a valid response, BX trials place demands on the fidelity (stability, memory) of the "B" cue state representation to overcome this tendency. Performance is assessed based on accuracy of responses. The primary outcome will be differences in task accuracy before and after modafinil administration.

  Day 7 (EEG + Modafinil Appointment)

• Dot Pattern Expectancy variation (TOPX) Task - Response Time

  The TOPX task consists of a series of pattern sequences. One pattern is designated the "A" cue, and another the "X" cue, which requires one response (AX, 60-70% of trials, e.g. respond with the left button), while other sequences require a different response (AY or BX, 12-15% of trials each, or BY, 6-10% of trials, e.g. respond with the right button). Given the strong expectation that X's evokes a valid response, BX trials place demands on the fidelity (stability, memory) of the "B" cue state representation to overcome this tendency. Response time performance is assessed based on the delay in the presentation of the stimuli and the selection of the response. The primary outcome will be differences in response times before and after modafinil administration.

  Day 7 (EEG + Modafinil Appointment)

• Translational Bandit Task (TBT) - Accuracy

  This is a task variant that uses choice options (neutral images) that are rewarded probabilistically. The rewarded stimulus with the highest reward is changed over time. State learning associated with staying or switching stimuli too quickly (lose-switching) can be evaluated. Performance is assessed based on selection of the option that will yield the highest reward. The primary outcome will be differences in task performance before and after modafinil administration.

  Day 7 (EEG + Modafinil Appointment)

• Translational Bandit Task (TBT) - Response time

  This is a task variant that uses choice options (neutral images) that are rewarded probabilistically. The rewarded stimulus with the highest reward is changed over time. State learning associated with staying or switching stimuli too quickly (lose-switching) can be evaluated. Performance is assessed based on the delay between the presentation of stimuli and the selection of the response. The primary outcome will be differences in task performance before and after modafinil administration.

  Day 7 (EEG + Modafinil Appointment)

• Translational Bandit Task (TBT) - Reward Seeking Behavior

  This is a task variant that uses choice options (neutral images) that are rewarded probabilistically. The rewarded stimulus with the highest reward is changed over time. State learning associated with staying or switching stimuli too quickly (lose-switching) can be evaluated. Performance is assessed based on the behavior of reward seeking-whether participants "explore" to find new reward scenarios, or if they stay to "exploit" a known reward scenario. The primary outcome will be differences in reward seeking behavior before and after modafinil administration.

  Day 7 (EEG + Modafinil Appointment)

Secondary Outcomes (1)

• Brief Psychiatric Rating Scale (BPRS) - Global Score

  Baseline

Other Outcomes (3)

• Abbreviated Quality of Life Scale (aQLS) - Global Score

  Baseline

• Global Functioning - Social Scale (GFS)

  Baseline

• Global Functioning - Role Scale (GFR)

  Baseline

Study Arms (1)

COSTEP 1

EXPERIMENTAL

Drug: Modafinil

Interventions

Modafinil DRUG

Single dose of 200mg

COSTEP 1

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• English proficiency, as determined by staff observation and participant self-report
• Estimated IQ at or above 70, as estimated by the cognitive assessments
• Is clinical stable, defined as outpatient status for at least one month prior to study participation
• Has clinically stable doses of medication for at least one month prior to study participation as determined by the PI
• Participants may have minor adjustments in medication doses in the past 30 days, per PI discretion, but may not have major increases or decreases in dosses, or additions or removal of medications in the past 30 days
• Participants are to have no changes to medications in the past 7 days before study medication administration (i.e., must have been on a stable dose for at least 7 days prior to receiving the study drug).

You may not qualify if:

• Medical criteria:
• Presence of the following medical concerns, as determined by the study PI:
• Major neurological disorder
• History of head injury with or without prolonged consciousness
• Any major medical condition that, in the opinion of the PI, would impede participation in the study or would put the participant at additional risk by participating
• History of any of the following as reported by the participant:
• Renal impairment, injury, or disease
• Hepatic impairment, injury, or disease
• Myocardial infarction or heart disease.
• The following cardiac symptoms requiring medical follow-up that, in the opinion of the investigator, would impede participation in the study or would put the participant at additional risk by participating
• Dsypnea
• Palpitations
• Orthopnea
• Pedal oedema
• Significant dizziness

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Sophia Vinogradov, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Caroline Demro, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaylee Enevold

CONTACT

612-403-4585; costep1@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: November 17, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be shared 1 year following study completion. There is no end date for data sharing.
• Access Criteria: Users who register with the NIMH Data Archive will be able to access the data.

Locations

US (1)