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Antioxidant
MitoQ for Schizophrenia
Lausanne, Switzerland
Phase 2 & 3
Recruiting
Led By Dost Ongur, MD, PhD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who have been diagnosed with one of the following schizophrenia-spectrum disorders: schizophreniform disorder, schizophrenia, schizoaffective disorder, unspecified psychosis
Male or female aged 18 to 35 years old
Must not have
Epilepsy or another seizure disorder
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 12
Summary
This trial is testing the effects of a supplement called MitoQ on the cognitive abilities of people with early phase schizophrenia-spectrum disorders who have mitochondrial dysfunction. Cognitive impairments in these individuals can cause significant
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Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions typical of antioxidant supplements such as digestive discomfort or allergic reactions. Regular check-ups will monitor any side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of schizophrenia or related disorder.
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I am between 18 and 35 years old.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have epilepsy or another seizure disorder.
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I speak English and can participate in the study.
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I am under legal guardianship.
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I am not pregnant, breastfeeding, planning to become pregnant, or under 18.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in the MATRICS Consensus Cognitive Battery (MCCB) composite score at week 12
Secondary study objectives
Change from baseline in the Clinical Global Impressions Severity (CGI-S) scale score at week 12
Change from baseline in the Global Assessment of Functioning (GAF) score at week 12
Change from baseline in the MATRICS Consensus Cognitive Battery (MCCB) attention/vigilance score at week 12
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MitoQExperimental Treatment1 Intervention
20 mg 2 capsules once daily for 12 weeks (total daily dose 40 mg)
Group II: PlaceboPlacebo Group1 Intervention
2 capsules (identical in appearance to MitoQ capsules) once daily for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MitoQ
2006
Completed Phase 2
~250
Find a Location
Closest Location:Yale School of Medicine· New Haven, CT
Who is running the clinical trial?
Yale UniversityOTHER
1,952 Previous Clinical Trials
3,043,441 Total Patients Enrolled
Mclean HospitalLead Sponsor
219 Previous Clinical Trials
22,291 Total Patients Enrolled
University of LausanneOTHER
107 Previous Clinical Trials
37,566 Total Patients Enrolled
Dost Ongur, MD, PhDPrincipal InvestigatorMclean Hospital
2 Previous Clinical Trials
385 Total Patients Enrolled