NCT06191965 MitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction
| NCT ID | NCT06191965 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Mclean Hospital |
| Condition | Schizophrenia and Related Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-06-01 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 people with early phase schizophrenia-spectrum disorders (E-SSD) who have mitochondrial dysfunction (called high risk, or HR). Cognitive impairments in SSD can cause significant disability. Yet, there are no effective treatments for cognitive impairments in SSD. It has been shown that alterations in a certain type of brain cell (parvalbumin interneurons, or PVI) underlie cognitive deficits in SSD. These PVI, which fire at a fast rate, utilize high amounts of energy from the mitochondria and are highly vulnerable to oxidative stress. MitoQ is an antioxidant. Research has shown that, in mice, MitoQ can reduce oxidative stress in the mitochondria. The main question that this clinical trial aims to answer is: • Does MitoQ supplementation, compared to placebo, improve cognition in HR patients? Secondary questions that this clinical trial aims to answer are the following: Does MitoQ supplementation, compared to placebo: * Improve positive and negative symptoms of SSD in HR patients? * Improve functioning in HR patients? * Improve/normalize blood markers of mitochondrial dysfunction in HR patients? The investigators will enroll 100 individuals with E-SSD. These enrolled participants will participate in an initial screening visit to determine if they qualify for the actual clinical trial. At the screening visit, the investigators will ask about psychiatric history to determine diagnosis; ask about medical history; do a physical exam; collect blood and urine samples; do a pregnancy test; and ask participants to bring in their current medications in their original packaging so it is known what they are taking. After the screening visit, the investigators will invite 50 HR patients (identified with a blood test) to continue with the clinical trial. Participants who qualify for the clinical trial will be asked to: * Take a supplement (MitoQ or placebo) once per day for 12 weeks in addition to their usual medications. * Come in for a study visit every 4 weeks over the 16-week study period. At these study visits, the investigators will do a physical exam; ask about symptoms and side effects; take blood and urine samples; and ask questions about general health and well-being, quality of life, mental health, emotional health, and mood. At visits 1 (baseline) and 4 (12 weeks), participants will also take a cognitive assessment.
Eligibility 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
Contact & Investigator
Dost Ongur, MD, PhD
PRINCIPAL INVESTIGATOR
Mclean Hospital
Frequently Asked Questions
Who can join the NCT06191965 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying Schizophrenia and Related Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06191965 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06191965 currently recruiting?
Yes, NCT06191965 is actively recruiting participants. Contact the research team at dongur@mgb.org for enrollment information.
Where is the NCT06191965 trial being conducted?
This trial is being conducted at New Haven, United States, Belmont, United States, Lausanne, Switzerland.
Who is sponsoring the NCT06191965 clinical trial?
NCT06191965 is sponsored by Mclean Hospital. The principal investigator is Dost Ongur, MD, PhD at Mclean Hospital. The trial plans to enroll 100 participants.
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