MitoQ treatment for early-phase schizophrenia and cognitive issues
Double Blind, Randomized, Placebo-Controlled Study of MitoQ as Adjunctive Treatment for Patients With Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction
PHASE2; PHASE3 · Mclean Hospital · NCT06191965
This study is testing if MitoQ, an antioxidant, can improve thinking skills in young adults with early-phase schizophrenia who have problems with their brain's energy production.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Mclean Hospital (other) |
| Locations | 3 sites (New Haven, Connecticut and 2 other locations) |
| Trial ID | NCT06191965 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of MitoQ, an antioxidant, on cognitive function in individuals aged 18 to 35 diagnosed with early-phase schizophrenia-spectrum disorders who exhibit mitochondrial dysfunction. Conducted as a double-blind, placebo-controlled trial, participants will receive either MitoQ or a placebo for 12 weeks. The primary outcome will be measured using the MATRICS Consensus Cognitive Battery to assess changes in global cognition. The study aims to enroll 100 patients across two sites, McLean Hospital and Yale School of Medicine, with a focus on those identified as high risk for cognitive impairment.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 35 with a diagnosis of schizophrenia-spectrum disorders and evidence of mitochondrial dysfunction.
Not a fit: Patients with a recent substance use disorder or significant acute medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for improving cognitive function in patients with early-phase schizophrenia-spectrum disorders.
How similar studies have performed: While the approach of using MitoQ is novel in this context, previous studies have shown promise in reducing oxidative stress in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
New Haven, Connecticut and 2 other locations
- Yale School of Medicine — New Haven, Connecticut, United States (NOT_YET_RECRUITING)
- McLean Hospital — Belmont, Massachusetts, United States (RECRUITING)
- University of Lausanne — Lausanne, Switzerland (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Dost Ongur, MD, PhD — Mclean Hospital
- Study coordinator: Dost Ongur, MD, PhD
- Email: dongur@mgb.org
- Phone: 6178553922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia and Related Disorders, Mitochondrial Alteration, Cognitive Impairment