MitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction

This study is testing if a medication called MitoQ can help improve thinking and memory (cognition) in people with early-stage schizophrenia-spectrum disorders. MitoQ is an antioxidant, which means it helps protect cells from damage. Researchers believe that problems with energy-producing parts of cells (mitochondria) might contribute to cognitive difficulties in these conditions. You might be able to join if you are 18-35 years old and have a diagnosis like schizophrenia or schizoaffective disorder, and have been in treatment for psychosis for less than five years. The study will compare MitoQ to a placebo (an inactive pill that looks the same) over 12 weeks. Success will be measured by changes in a specific cognitive test score.

Study design: This is a double-blind, randomized, placebo-controlled study, meaning neither you nor your doctors will know if you are receiving MitoQ or the placebo. It plans to enroll 100 participants.
What's involved: You would take MitoQ or a placebo capsule twice a day for 12 weeks. You will have assessments at the beginning and at week 12, including a cognitive test and a blood test.
Compensation: Not stated in the trial record.
Follow-up: Your cognitive test results will be measured at the end of the 12-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

MitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction

Recruiting

PHASE2Ages 18–35InterventionalTreatment

Mclean Hospital

~100 participants

Updated 2025-09-25 on ClinicalTrials.gov

What's tested:MitoQPlacebo

At a glance

Recruiting sites

1 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change from baseline in the MATRICS Consensus Cognitive Battery (MCCB) composite score at week 12

Measured over Baseline and week 12

Conditions

Schizophrenia and Related Disorders

Mitochondrial Alteration

Cognitive Impairment

Where it's being run

3 sites across 3 states

Connecticut1

Massachusetts1

Switzerland1

Study leadership

Dost Ongur, MD, PhD · PRINCIPAL_INVESTIGATOR · Mclean Hospital

Who to contact

Dost Ongur, MD, PhD

[email protected]

6178553922

Email the study team

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Do you actually qualify for this trial?

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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

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

What this trial measures

Change from baseline in the MATRICS Consensus Cognitive Battery (MCCB) composite score at week 12Baseline and week 12
The MCCB evaluates cognitive functioning in schizophrenia and related disorders. It includes ten tests that measure seven cognitive domains including speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB composite score has been shown to be highly correlated with general level of intellectual ability.

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