Psychosis study: Modafinil vs D-serine solution
Official title Cognitive Strategies in Early Psychosis 2
ClinicalTrials.gov ID: NCT07263022
What this study is testing
What is Modafinil?
investigational oral medication being studied for its effects on decision making in psychosis spectrum disorders is designed to increase dopamine signaling by inhibiting dopamine reuptake
Also referred to as Provigil.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a single dose of modafinil or d‑serine changes how people with early psychosis play brain games and how their brain works.
- Who it's for
- You may be able to join if you have had psychosis symptoms start within the last five years.
- What's involved
- You will answer interview questions and fill out surveys. You will give a blood sample, a urine sample, and a breath test for alcohol. You will have brain scans (fMRI) and take a study pill during each visit. You will play computer brain games that test decision making and problem solving.
- Time commitment
- You will attend six visits about a month apart, each with two brain scans and the study pill.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35
You may be able to join if
- Between the ages of 18 and 35
- Onset of a psychosis spectrum illness (schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with...
- 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
You likely can't join if
- 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...
- Renal impairment, injury, or disease
- Hepatic impairment, injury, or disease
- Dyspnea
See the full eligibility 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...
- 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...
- 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).
- 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
- Renal impairment, injury, or disease
- Hepatic impairment, injury, or disease
- 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)
- 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
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.