MitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2027

Conditions
Schizophrenia and Related DisordersMitochondrial AlterationCognitive Impairment
Interventions
DRUG

MitoQ

"MitoQ is a synthetic analogue of coenzyme Q10. It is produced by the company Antipodean Pharmaceuticals and is formulated as a stable yellow powder suitable for oral formulation, prepared as capsules of white color. It is a commercial dietary supplement sold over the counter as an antioxidant, to be taken orally once or twice a day. It has subsequently been tested for various clinical conditions in humans.~1. Molecular formula: C38H47O7PS (C37H44O4P.CH3O3S)~2. CAS number: 444890-41-9 (phosphonium cation)~3. Molecular weight: 678.81~4. MitoQ capsules: The standard commercial posology is a 20 mg daily dose. All formulations are produced following Good Manufacturing Practice (GMP) standards (https://www.who.int/medicines/areas/quality\_safety/quality\_assurance/TRS986annex2.pdf?ua=1).~5. MitoQ will be administered in oral capsules provided by the manufacturer Antipodean Pharma, to be taken once daily, one hour before breakfast. The daily dose will be 2 pills, i.e., 40 mg MitoQ."

DRUG

Placebo

Placebo pills in identical appearance to the MitoQ capsules will be produced and provided by Antipodean Pharma and given to the patients in the control arm two per day to be taken one hour before breakfast. The composition of the placebo is tapioca starch, microcrystalline cellulose, hypromellose, silica-colloidal anhydrous, purified water, carrageenan, and pectin.

Trial Locations (3)

06519

NOT_YET_RECRUITING

Yale School of Medicine, New Haven

02478

RECRUITING

McLean Hospital, Belmont

Unknown

NOT_YET_RECRUITING

University of Lausanne, Lausanne

All Listed Sponsors
collaborator

Yale University

OTHER

collaborator

University of Lausanne

OTHER

lead

Mclean Hospital

OTHER