Cognitive Strategies in Early Psychosis 2

University of Minnesota1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2026年7月17日最近更新: 2026年7月23日

适应症

干预措施

试验速览

阶段: 3 期
状态: 招募中
发起方: University of Minnesota
入组人数: 24
试验地点: 1
主要终点: Test My Brain - Verbal Paired Associates Memory

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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.

Intake Appointment:

The first appointment is the Intake appointment. This visit will take between 1.75-2.75 hours, depending on how many study tasks are needed. Participants in this study may have participated in a sister study, called "State Representation in Early Psychosis 2 (STEP 2)." If so, they will not need to complete many of the intake questionnaires, and it is expected to take about 100 minutes for them to complete this appointment. If they did not participate in STEP 2, participants will need to complete the full intake battery.

During the interview, the investigators will ask questions about a participant's medical and psychiatric history, and current and past mental health symptoms. They will collect demographics, as well as information on the person's social life and quality of life. Participants will also provide a blood sample for clinical safety screening. The investigators will collect one 3mL tube, which is less than 2/3 of a teaspoon. 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. Participants will come in person to the University of Minnesota Center for Magnetic Resonance Research. This visit will take about 7-7.5 hours.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Basic Science
盲法: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 35 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•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).

排除标准

•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:
•Palpitations
•Orthopnea
•Pedal oedema
•Significant dizziness
•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

研究组 & 干预措施

Arm 3: D-serine > modafinil > placebo

Experimental

Participants will take single doses of three study medications in the following order: d-serine (100 mg/kg); modafinil (200 mg); and placebo. All medications will be taken 2 times (A>B>C>A>B>C).