Status:
RECRUITING
MitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Yale University
University of Lausanne
Conditions:
Schizophrenia and Related Disorders
Mitochondrial Alteration
Eligibility:
All Genders
18-35 years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this double-blind, placebo-controlled randomized clinical trial is to test the effect of 12 weeks of orally administered MitoQ (mitoquinol mesylate) supplementation on cognition in 50 peop...
Detailed Description
The planned clinical trial aims to test the effect of an oral administration of MitoQ on neurocognition, psychiatric symptoms, functioning, and exosomal levels of the mechanism-based biomarkers miR-13...
Eligibility Criteria
Inclusion
- Male or female aged 18 to 35 years old
- Patients who have been diagnosed with one of the following schizophrenia-spectrum disorders: schizophreniform disorder, schizophrenia, schizoaffective disorder, unspecified psychosis.
- Less than five years in treatment for psychosis (note that the duration of psychosis may be longer than 5 years, but this is more difficult to ascertain and therefore less reliable as an inclusion criterion).
- PANSS score \< 75
- Ability to provide informed consent.
Exclusion
- Meeting DSM-5 criteria for any substance use disorder diagnosis in the past 6 months will be exclusionary EXCEPT tobacco and mild/moderate cannabis use disorder, which will be included
- Any acute medical condition requiring actively changing treatment (e.g., autoimmune disorders, acute infections, HIV/AIDS, cancer, renal failure, hepatic dysfunction, cardiovascular disease, or abnormal thyroid findings). Individuals with chronic medical conditions that are stable will not be excluded (e.g., person with hypothyroidism who is taking thyroid hormone replacement and has TSH levels within the normal range; person with well-managed diabetes; etc.)
- Epilepsy or another seizure disorder
- Intellectual disability (e.g., history of IQ \< 70).
- Under legal guardianship
- Not English speaking. The questionnaires, instruments, cognitive assessments used in this research study have not been translated, validated, or studied extensively in non-English-speaking individuals. For this reason, we will not enroll individuals who do not speak English to maintain validity in the study.
- MitoQ allergy
- Treatment with antioxidants: omega3 (fish oil), Vitamin E, Vitamin C, multivitamins, NAC (N-acetyl cysteine) within the last 14 days. If the treatment is taken without prescription, we will ask the patient to stop using it for at least 14 days to become eligible for the present study.
- Children and adolescents, pregnant women, women who have the intention to become pregnant during the course of the study, and breastfeeding women are excluded from the study. This is because no MitoQ pharmacokinetic data are available in pediatric populations, pregnancy or breastfeeding.
- Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of childbearing potential.
- Enrollment of study staff, their family members, and other dependent persons
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06191965
Start Date
June 1 2024
End Date
January 31 2027
Last Update
September 25 2025
Active Locations (3)
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1
Yale School of Medicine
New Haven, Connecticut, United States, 06519
2
McLean Hospital
Belmont, Massachusetts, United States, 02478
3
University of Lausanne
Lausanne, Switzerland