RecruitingPhase 3

Cognitive Strategies in Early Psychosis 1

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 35 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 month
  • Procedures mentioned: Questionnaires, Interviews, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "These appointments will ideally be about 1 week apart, but can be up to 1 month apart if needed."
  • "During the interview, the investigators will ask questions about a participant's medical and psychiatric history, and current and past mental health symptoms."
  • "After the interview, they will complete brain games on their computer."
  • "This will include: * A blood draw for lab testing."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether one dose of modafinil changes decision making and brain activity in people without psychosis. Participants play computer brain games and wear an EEG cap, which measures electrical activity in the brain. Researchers hope to better understand illnesses like schizophrenia.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can use English well enough to take part.
  • Have an estimated IQ score of at least 70 on thinking tests.
  • Have been stable and receiving care outside a hospital for at least one month.
  • Have had stable medicine doses for at least one month. The study doctor may allow small changes, but no medicine changes are allowed in the 7 days before taking the study drug.

Who can't join

  • Have a major brain or nerve disorder, a past head injury, kidney or liver problems, heart disease, or another medical problem that makes joining unsafe. Certain heart symptoms, low white blood cells, high blood pressure, a fast resting pulse, or abnormal lab tests also rule out joining.
  • Are pregnant, planning pregnancy, or breastfeeding; or cannot pass the eyesight test.
  • Take modafinil already, are allergic to it, or take medicines or supplements that strongly interact with it. A past severe skin reaction to medicine called Stevens-Johnson syndrome also rules out joining.
  • Have had severe alcohol or drug use problems in the past 3 months, or have ever had a stimulant use disorder.
  • Have a risk of suicide, including current suicidal thoughts or certain plans, preparations, or attempts in the past 6 months; or have had a depressive episode in the past month.
  • Have a psychotic disorder, bipolar disorder, or autism, or have a parent, sibling, or child with one of these conditions.
  • Take medicines or supplements that affect mood or thinking, or have other mental health problems that make taking part unsafe or difficult.
  • Cannot or do not want to give informed consent, cannot make an informed choice about joining, cannot read or write, or have done substantial brain training in the past year.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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). Exclusion Criteria: 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 * Syncope * Claudication ---Low white blood cell count, or is diagnosed with leukopenia, neutropenia, or agranulocytosis * Presence of unmanaged hypertension (\>140/90) or elevated resting heart rate (\>100 bpm) * Abnormal clinical laboratory values: * uACR \> 30 mg/g * creatinine level \>0/95 mg/dL * AST or ALT \>50 U/L * Bilirubin \>1.2 mg/dL * Total Protein \<6 g/dL * Participant is pregnant, planning to become pregnant, or is breastfeeding * Participant cannot pass the visual acuity test (e.g., a score lower than 20/25 on the Snellen) * Takes medications or supplements that have major interactions with modafinil (e.g., ketamine, MAOIs, clomipramine, diazepam, propranolol, warfarin, amphetamine or dextroamphetamine, dexmethylphenidate or methylphenidate) * Has an allergy to modafinil * Is currently taking modafinil as a prescription * Has previously experienced Stevens-Johnson syndrome in response to taking a medication Mental health criteria: * Meets criteria for severe substance or alcohol use disorder within 3 months of enrollment * Lifetime history of stimulant use disorder * Meets criteria for clinical risk of suicidal behavior, as defined by: * Clinician judgment * Active suicidal ideation at screening or other appointments * Previous intent to act on suicidal ideation with a specific plan and/or preparatory acts within 6 months of enrollment * A suicide attempt within 6 months of enrollment * Meets criteria for a depressive episode within the past month as determined by the diagnostic interview or for a severe or extremely severe depressive episode in the abbreviated battery within the past month * Meets DSM-5 criteria for, or reports professional diagnosis of, a psychotic, bipolar, or autism spectrum disorder * Has a family history (1st degree relative) of psychotic, bipolar, or autism spectrum disorder * Is prescribed psychotropic medications or takes supplements with psychotropic effects (e.g., Nootropics) * Any other psychiatric symptoms or conditions that, in the opinion of the PI, would impede participation in the study or put the participant at additional risk by participating Other Criteria: * Unable or unwilling to provide informed consent * Unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study * Participant is illiterate * Have engaged in significant cognitive training, in the opinion of the PI, in the last year

Study sites (1)

MN