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Antioxidant

MitoQ for Mitochondrial Dysfunction

Phase 2 & 3

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 12

Awards & highlights

Study 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

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 below

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

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I am between 18 and 35 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in the MATRICS Consensus Cognitive Battery (MCCB) composite score at week 12

Secondary outcome measures

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 more

Trial 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

~230

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor

213 Previous Clinical Trials

21,594 Total Patients Enrolled

University of LausanneOTHER

105 Previous Clinical Trials

37,507 Total Patients Enrolled

Yale UniversityOTHER

1,848 Previous Clinical Trials

2,737,718 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the eligibility criteria to be enrolled in this research study?

"To be eligible for this research study, individuals must have a diagnosis of schizophrenia and fall between the ages of 18 and 35. The trial aims to enroll a total of 100 participants."

Answered by AI

Are patients currently able to participate in this ongoing research study?

"As per the latest information from clinicaltrials.gov, this specific study is not actively seeking participants at present. The initial posting of the trial was on February 1st, 2024, and it was last edited on January 4th, 2024. However, there are currently 487 other ongoing clinical trials that are actively enrolling patients."

Answered by AI