MitoQ for Schizophrenia

Recruiting at 2 trial locations

Overseen By Dost Ongur, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Mclean Hospital

Must be taking: Antipsychotics

Must not be taking: Antioxidants

Disqualifiers: Substance use disorder, Epilepsy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a supplement called MitoQ can improve thinking and memory in individuals with early-phase schizophrenia-spectrum disorders who have mitochondrial issues (the energy producers in cells). Participants will take either MitoQ or a placebo for 12 weeks, while researchers observe changes in cognitive abilities, symptoms, and overall functioning. The trial seeks individuals diagnosed with schizophrenia-related conditions, who have been in treatment for less than five years, and experience daily challenges due to cognitive impairments.

As a Phase 2 trial, this research measures MitoQ's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

You can continue taking your usual medications during the trial, but you must stop taking any antioxidant supplements like omega-3, Vitamin E, Vitamin C, multivitamins, or NAC at least 14 days before starting the study.

Is there any evidence suggesting that MitoQ is likely to be safe for humans?

Research shows that MitoQ is generally safe for use. Studies have found that even at high doses, MitoQ does not significantly harm the kidneys. This indicates it doesn't damage the kidneys, even in larger amounts. MitoQ functions as an antioxidant, protecting the cell's energy centers, known as mitochondria, from stress-related damage. Although this trial does not specifically focus on kidney health, evidence suggests that MitoQ is safe for humans at the doses tested. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for schizophrenia?

MitoQ is unique because it targets oxidative stress in the brain, which is not the focus of most current schizophrenia treatments. While standard medications like antipsychotics primarily address dopamine imbalances, MitoQ is an antioxidant that aims to protect brain cells from damage and improve mitochondrial function. Researchers are excited about MitoQ because it offers a novel approach by potentially enhancing brain health at a cellular level, which could lead to improved outcomes for patients beyond what traditional treatments offer.

What evidence suggests that MitoQ might be an effective treatment for schizophrenia?

Research has shown that MitoQ, a type of antioxidant, can reduce damage in mitochondria, the energy-producing parts of cells. This is crucial because such damage can impair certain brain cells involved in thinking, which often malfunction in people with schizophrenia. One study found that MitoQ was 24% more effective than another antioxidant, CoQ10, at reducing this damage. In mice, MitoQ demonstrated potential in protecting these brain cells, which might help with thinking problems in schizophrenia. While research in humans continues, this trial will evaluate whether MitoQ could improve thinking abilities for those with schizophrenia. Participants will receive either MitoQ or a placebo to assess its effectiveness. ^{1 2 5 6 7}

Who Is on the Research Team?

Dost Ongur, MD, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with early-phase schizophrenia-spectrum disorders who also show signs of mitochondrial dysfunction. To join, they must pass a screening that includes psychiatric and medical history reviews, physical exams, and blood tests to confirm high-risk status.

Inclusion Criteria

I have been diagnosed with a type of schizophrenia or related disorder.

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

Exclusion Criteria

MitoQ allergy

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive MitoQ or placebo supplementation once daily for 12 weeks

12 weeks

4 visits (in-person) every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MitoQ
• Placebo

Trial Overview The study is testing if MitoQ (an antioxidant supplement) can improve cognition in patients over a 12-week period compared to a placebo. Participants will continue their usual medications while adding the supplement or placebo.

How Is the Trial Designed?

Group I: MitoQ Experimental Treatment 1 Intervention

20 mg 2 capsules once daily for 12 weeks (total daily dose 40 mg)

Group II: Placebo Placebo Group 1 Intervention

2 capsules (identical in appearance to MitoQ capsules) once daily for 12 weeks

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

University of Lausanne

Collaborator

Trials

108

Recruited

37,700+

Published Research Related to This Trial

In a phase 1b study with 37 patients and a phase 2 study involving 240 outpatients, the PDE10A inhibitor PF-02545920 was found to be well tolerated, indicating a good safety profile for this treatment approach.

Despite being well tolerated, PF-02545920 did not show significant efficacy in improving symptoms of schizophrenia compared to placebo, suggesting that PDE10A inhibitors may not be effective as antipsychotic agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Proof-of-Concept Study Evaluating the Phosphodiesterase 10A Inhibitor PF-02545920 in the Adjunctive Treatment of Suboptimally Controlled Symptoms of Schizophrenia. DeMartinis, N., Lopez, RN., Pickering, EH., et al.[2020]

The study found that both LY379268, an mGlu2/3 receptor agonist, and BINA, an mGlu2 receptor positive allosteric modulator, effectively reduced the immobility time in rats subjected to negative symptoms induced by MK-801, suggesting their potential as treatments for schizophrenia's negative symptoms.

These compounds did not affect immobility in saline-treated rats, indicating their specific action on the negative symptoms of schizophrenia rather than general sedative effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation of the metabotropic glutamate (mGlu) 2 receptor attenuates the MK-801-induced increase in the immobility time in the forced swimming test in rats. Kawaura, K., Karasawa, J., Hikichi, H.[2020]

In a meta-regression analysis of 18 double-blind, randomized, placebo-controlled trials involving 998 patients with stable schizophrenia, drugs were found to be more effective than placebo in reducing negative symptoms, although the effect size was small (Cohen's d: 0.208).

The study revealed a significant placebo response (Cohen's d: 2.909), indicating that factors like the number of trial arms, study sites, and industry sponsorship can influence the placebo effect, suggesting a need for improved trial designs to accurately assess treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Placebo Response in Pharmacological Clinical Trials of Negative Symptoms in Schizophrenia: A Meta-regression Analysis. Fraguas, D., Díaz-Caneja, CM., Pina-Camacho, L., et al.[2022]

In a study involving 13 outpatients with chronic but stable schizophrenia, donepezil significantly improved negative symptoms of schizophrenia compared to baseline and placebo, as measured by the Positive and Negative Symptom Scale (PANSS).

The study used a randomized, counterbalanced design over 24 weeks, with participants receiving donepezil at two different doses (5 mg and 10 mg) and a placebo, highlighting the potential of cholinesterase inhibitors as an effective augmentation strategy for managing schizophrenia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind donepezil-placebo crossover augmentation study of atypical antipsychotics in chronic, stable schizophrenia: a pilot study. Risch, SC., Horner, MD., McGurk, SR., et al.[2018]

A meta-analysis of 92 trials involving 22,645 participants found that long-acting injectable (LAI) and oral antipsychotics significantly prevent relapse in schizophrenia-spectrum disorders, with high confidence in the effectiveness of amisulpride, olanzapine, and aripiprazole.

Both LAI and oral formulations of olanzapine, aripiprazole, and paliperidone are recommended as the best options for maintenance treatment, particularly in resource-limited settings, as they showed the highest efficacy for relapse prevention without significant tolerability issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral and long-acting antipsychotics for relapse prevention in schizophrenia-spectrum disorders: a network meta-analysis of 92 randomized trials including 22,645 participants. Ostuzzi, G., Bertolini, F., Tedeschi, F., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06191965

MitoQ for Early-phase Schizophrenia-spectrum Disorder ... The planned clinical trial aims to test the effect of an oral administration of MitoQ on neurocognition, psychiatric symptoms, functioning, and exosomal levels ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/449422

MitoQ for Early-phase Schizophrenia-spectrum Disorder ... The goal of this double-blind, placebo-controlled randomized clinical trial is to test the effect of 12 weeks of orally administered MitoQ ...

3. withpower.com withpower.com/trial/phase-2-and-3-schizophrenia-1-2024-ae7ec

MitoQ for Schizophrenia · Recruiting Participants for Phase ... The goal of this double-blind, placebo-controlled randomized clinical trial is to test the effect of 12 weeks of orally administered MitoQ (mitoquinol ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40820063/

evaluating its effects on clinical outcomes and oxidative ... This pilot randomized clinical trial investigated mitoquinone mesylate (MitoQ), a mitochondria-targeted antioxidant, on clinical outcomes ...

5. mitoq.com mitoq.com/pages/research?srsltid=AfmBOorIqMLoFJDqVZgXQ2BDpFXmLl3sAhO08aJYLMiKuh5IYYTxOcqK

mitoquinol mesylate research studies & clinical trials After six weeks of supplementation, MitoQ was found to be 24% more effective than CoQ10 at reducing hydrogen peroxide levels in the mitochondria during states ...

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/449422

MitoQ for Early-phase Schizophrenia-spectrum Disorder ... 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 ...

7. mitoq.com mitoq.com/pages/research?srsltid=AfmBOoqFK0ePEJLF23_BHw81LCWtmwxMbd6hr84f8aqbpEsj522Cqm86

mitoquinol mesylate research studies & clinical trials Results found that acute, high-dose MitoQ supplementation did not result in high concentrations of kidney injury biomarkers compared to placebo samples.