RecruitingPhase 3

Cognitive Strategies in Early Psychosis 2

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
Not 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

  • Procedures mentioned: Blood draws, MRI scans, Questionnaires, Interviews, Phone or video check-ins, Urine samples

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. * Complete functional Magnetic Resonance Imaging (fMRI) scans. fMRI uses magnets to take pictures of the brain."
  • "Participants will be asked to complete ten appointments in this study: An intake appointment, 6 functional Magnetic Resonance Imaging (fMRI) appointments, and 3 clinical interview appointments."
  • "In addition, there will be 3 brief clinical check ins, and 6 phone call check ins after fMRI appointments."
  • "During the interview, the investigators will ask questions about a participant's medical and psychiatric history, and current and past mental health symptoms."
  • "Participants will also provide a blood sample for clinical safety screening."
  • "If pregnancy is a physical possibility, they will also collect a urine sample for pregnancy testing. fMRI Appointments: The second appointment is an fMRI + study agent appointment."
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 how modafinil and d-serine affect decision making and brain activity compared with a placebo, which has no active drug. It is for adults ages 18–35 whose psychosis symptoms, such as trouble knowing what is real, began within the past 5 years. Participants take study doses, play computer brain games, and have brain scans.

The goal of this clinical trial is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. Participants will be people who have had symptoms of a psychosis spectrum disorder start within the last five years. The investigators will study how two study agents change decision making in people with psychosis, by asking participants to complete some brain games on the computer before and after taking the study agents. The investigators 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 with psychosis play the brain games? * Does a single dose of d-serine change how people with psychosis play the brain games? * Does a single dose of modafinil change brain activity? * Does a single dose of d-serine 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. * Complete functional Magnetic Resonance Imaging (fMRI) scans. fMRI uses magnets to take pictures of the brain. There will be six scanning appointments in the study, with two scans each. Appointments will be about a month apart. * Take a single dose of a study agent during each scanning appointment. The study agent will be taken after the first fMRI. There are three study agents in total: modafinil, d-serine, and a placebo. Each participant will take each study agent twice during the study. * Play brain games on a computer that measure decision making, thinking, and problem solving skills

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

Eligibility

Who can join

  • You are 18–35 years old.
  • You have a disorder with psychosis, such as schizophrenia or bipolar disorder with psychosis, that began within 5 years of joining.
  • Your estimated IQ score, a measure of thinking skills, is at least 70.
  • You can use English well enough to take part, as judged by the study team.
  • Your mental health medicines have not changed within 7 days of joining or MRI visits.
  • You have had no major medicine changes for at least 1 month before taking part or MRI visits. Small dose changes may be allowed, but no medicine changes are allowed in the 7 days before a study dose.

Who can't join

  • You have a major brain or nerve disorder, a serious past head injury, or another health problem that makes taking part unsafe or difficult.
  • You have a history of kidney or liver problems, heart disease or concerning heart symptoms, or low white blood cells. Uncontrolled blood pressure above 140/90, a resting pulse above 100, or certain abnormal blood or urine tests also rule you out.
  • You take a medicine or supplement that strongly interacts with a study drug, or you are allergic to a study drug.
  • You are pregnant, plan to become pregnant, or are breastfeeding; cannot pass the vision test; or cannot safely have an MRI scan.
  • You have had a severe alcohol or drug use disorder in the past 3 months, or a stimulant use disorder at any time.
  • You have current mania, meaning unusually high mood or energy; a mental health hospital stay in the past 3 months; suicide risk; certain severe symptoms; or other mental health problems that make taking part unsafe or difficult.
  • You cannot or will not give informed consent, cannot make an informed choice about joining, have a legal guardian, or are under a civil commitment order or a paused order for required mental health care.
  • You cannot read or have done a large amount of training to improve thinking skills in the past year, as judged by the study leader.

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

Official eligibility criteria

Inclusion Criteria: * Between the ages of 18 and 35 * Onset of a psychosis spectrum illness (schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis) within 5 years of enrollment * Estimated IQ of 70 or above * Proficient at English as determined through interactions with the study team * No change in psychiatric medication within a week of enrollment or MRI study visits * No clinically significant change in any medications for at least 1 month prior to study participation or MRI study visits, as determined by PI/Co-Is * Participants may have minor adjustments in medication doses in the past 30 days, per PI discretion, but may not have had major increases or decreases in doses, or additions or removal of medication within the past 30 days. * Participants are to have no changes to medications in the past 7 days before drug 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 a clinically significant head injury with or without prolonged unconsciousness * 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, or endorsement of history of or of cardiac symptoms at intake: * Dyspnea * 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 * Taking a medication or supplement that has a major drug interaction with any study drugs (e.g., ketamine, MAOIs, clomipramine, diazepam, propranolol, warfarin) * Allergies to study drugs * Is pregnant, planning to become pregnant, or is breastfeeding * Cannot pass the visual acuity test * Cannot pass the CMRR Subject Safety Screen due to MRI contraindications Mental health criteria: * Meets criteria for a severe substance or alcohol use disorder within 3 months of enrollment * Lifetime history of a stimulant use disorder * Current manic episode as determined by the MINI * History of psychiatric hospitalization within 3 months of enrollment * Meets criteria for clinical risk of suicidal behavior, as defined by: * Clinician judgment * A suicide attempt within 3 months of enrollment * Active suicidal ideation at screening or baseline, as indicated by the C-SSRS Screener * Previous intent to act on suicidal ideation with a specific plan and/or preparatory acts within 3 months of enrollment, as indicated by the C-SSRS Screener * Symptom severity scores in the severe (6) or extremely severe (7) range on the BPRS for the following items: suicidality, disorientation, bizarre behavior, excitement, elevated mood * 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 * Current guardianship * Is under civil commitment or under a stay of civil commitment * Illiteracy * Has engaged in significant cognitive training, in the opinion of the PI, in the last year

Study sites (1)

MN