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Led by Mclean Hospital · Updated on 2025-09-25
100
Participants Needed
3
Research Sites
N/A
Total Duration
Researchers are evaluating the effect of a 12-week oral supplementation with MitoQ, an antioxidant, on cognitive function in adults aged 18 to 35 with early-phase schizophrenia-spectrum disorders E-SSD who have mitochondrial dysfunction. This randomized, double-blind, placebo-controlled trial aims to determine if MitoQ improves cognition compared to placebo and also assesses effects on psychiatric symptoms, functioning, and blood markers related to mitochondrial health. Participants will be randomly assigned to receive either 40 mg of MitoQ daily two capsules or placebo capsules that look identical, taken once a day for 12 weeks. The study includes an initial screening to identify high-risk patients with mitochondrial dysfunction via blood tests. Those who qualify will continue with the trial and attend study visits every 4 weeks during the 16-week period, receiving either MitoQ or placebo alongside their usual medications. During the study visits, participants will undergo physical exams, symptom and side effect assessments, blood and urine sample collection, and questionnaires about health, mood, and quality of life. Cognitive testing will be done at baseline and at 12 weeks using the MATRICS Consensus Cognitive Battery. Researchers will measure changes in cognitive function, psychiatric symptoms, functioning, and mitochondrial biomarkers. Safety monitoring includes recording side effects, vital signs, hospital visits, and EKGs at key points. A follow-up visit will occur 4 weeks after treatment ends.
CONDITIONS
MitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction
D
Dost Ongur, MD, PhD
S
Steve Prete, RN
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Mclean Hospital
Lead Sponsor
Yale University
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | MitoQ | Placebo | CoQ10 (contextual) |
|---|---|---|---|
| What it is | An investigational oral antioxidant supplement (MitoQ) evaluated as an add‑on in early-phase schizophrenia‑spectrum with mitochondrial dysfunction | A matching inert placebo control given orally with the same schedule | Oral Coenzyme Q10 supplementation has been studied as a mitochondrial antioxidant in schizophrenia cognitive impairment |
| Role in the trial | Randomized investigational treatment arm receiving MitoQ daily for 12 weeks | Randomized control arm receiving matched placebo daily for 12 weeks | Not part of this trial; serves as a comparator from broader research on mitochondrial antioxidants |
| Primary use | Studied as adjunctive treatment to improve cognition in early‑phase schizophrenia | Control arm to measure effect of MitoQ versus inert comparator | Used in some clinical studies to evaluate cognitive or functional effects in schizophrenia as a mitochondrial antioxidant |
| How it is given or performed | Oral capsules of MitoQ taken once daily for 12 weeks as adjunct to standard care | Oral placebo capsules given once daily for 12 weeks matching MitoQ schedule | Oral supplementation (typically several hundred mg daily in trials), taken as adjunct to antipsychotic treatment |
| Evidence status | No published results yet; trial is ongoing | Placebo serves as comparator; no independent evidence | Some evidence from a randomized controlled trial suggests CoQ10 had no clear effect on cognitive or psychological outcomes in schizophrenia |
| Important risks | Safety profile under evaluation; known risks not described yet | Placebo generally presumed low risk but safety monitoring still required | CoQ10 is generally well tolerated in trials, but specific safety data in schizophrenia not well established |
| Important limitations | Results are pending; cognitive effects are not yet known | Effect depends entirely on study results comparing with MitoQ | Evidence base is limited with at least one RCT showing no benefit on cognition or symptoms |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including blood test to determine high risk (HR) status
Duration - 12 weeks
Participants with high risk status receive either MitoQ or placebo daily for 12 weeks as an adjunctive treatment to assess changes in cognition and symptoms.
Visits at start of treatment (week 0), during treatment, and at week 12 for assessments and safety monitoring
Duration - 4 weeks
Participants are monitored 4 weeks after the end of treatment to assess lasting effects and safety.
1 follow-up visit
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Ines Khadimallah, Raoul Jenni, Jan-Harry Cabungcal...
https://pubmed.ncbi.nlm.nih.gov/34686767/Mclean Hospital
Lead Sponsor
Yale University
Collaborating Sponsor
