Mitochondrial, exosomal miR137-COX6A2 and gamma synchrony as biomarkers of parvalbumin interneurons, psychopathology, and neurocognition in schizophrenia.
Ines Khadimallah, Raoul Jenni, Jan-Harry Cabungcal...
https://pubmed.ncbi.nlm.nih.gov/34686767Actively Recruiting
Phase 2
Phase 3
Age: 18Years - 35Years
All Genders
ID06191965
Double Blind, Randomized, Placebo-Controlled Study of MitoQ as Adjunctive Treatment for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction
Led by Mclean Hospital · Updated on 2025-09-25
100
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mclean Hospital
Lead Sponsor
Y
Yale University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Brief Title
MitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction
Who Can Participate
Age: 18Years - 35Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 35 years old
- Diagnosed with schizophreniform disorder, schizophrenia, schizoaffective disorder, or unspecified psychosis
- In treatment for psychosis for less than five years
- PANSS score less than 75
- Able to provide informed consent
You will not qualify if you...
- Substance use disorder diagnosis in the past 6 months except tobacco and mild/moderate cannabis use
- Any acute medical condition requiring changing treatment (e.g., autoimmune disorders, infections, HIV/AIDS, cancer, renal failure, liver dysfunction, cardiovascular disease, abnormal thyroid)
- Epilepsy or other seizure disorders
- Intellectual disability (history of IQ less than 70)
- Under legal guardianship
- Not English speaking
- Allergy to MitoQ
- Treatment with antioxidants such as omega-3, Vitamin E, Vitamin C, multivitamins, NAC within last 14 days
- Pregnant, breastfeeding, or intending to become pregnant during the study
- Lack of safe contraception in women of childbearing potential
- Study staff, their family members, and dependents excluded from participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
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
Treatment
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
Follow-up
Duration - 4 weeks
Participants are monitored 4 weeks after the end of treatment to assess lasting effects and safety.
1 follow-up visit
Trial Site Locations
Total: 3 locations
1
Yale School of Medicine
New Haven, Connecticut, United States, 06519
Not Yet Recruiting
2
McLean Hospital
Belmont, Massachusetts, United States, 02478
Actively Recruiting
3
University of Lausanne
Lausanne, Switzerland
Not Yet Recruiting
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Research Team
D
Dost Ongur, MD, PhD
S
Steve Prete, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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