A Randomised Controlled Trial of Coenzyme Q10 in Patients With Schizophrenia and Schizoaffective Disorder

Coenzyme Q10 in the Amelioration of Cognitive Deficits and Symptoms in Schizophrenia and Schizoaffective Disorder

The study is a randomised placebo controlled trial of Coenzyme Q10 (CoQ10) vitamin supplementation in a sample of patients with schizophrenia or schizoaffective disorder. CoQ10 is produced in the mitochondria of our cells, and is involved in the production of energy. However, some people do not produce enough CoQ10, which can result in difficulties with concentration and memory, depressive symptoms, low energy levels and high blood pressure. The study will examine the impact of taking oral CoQ10 supplementation on patients with schizophrenia and schizoaffective disorder.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Other: Placebo; Dietary supplement: Coenzyme Q10

Detailed Description

Coenzyme-Q10 (CoQ10) is an essential cofactor in the mitochondrial electron-transport-chain in addition to being a potent lipophilic antioxidant. Deficits in CoQ10 status have been linked to cardiovascular disease, cognitive decline, fatigue, and depression. CoQ10 supplementation may have a potential therapeutic value for patients with schizophrenia and schizoaffective disorder. This is a double-blind, placebo-controlled, randomised trial that will compare neurocognitive performance and symptoms of schizophrenia and schizoaffective disorder in participants randomised to active CoQ10 compared to scores from participants who received placebo. CoQ10 will be administered at a dose of 300mg/day, delivered in 3 doses of 100mg each. Participants will take CoQ10/placebo for 6 months. At three time points (baseline, 3 months and 6 months) each participant completes a neurocognitive and psychological battery of assessments. Blood pressure is monitored, and blood samples to assess mitochondrial function and plasma CoQ10 status are taken at each assessment.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • Clinical Research Facility, St James's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of schizophrenia or schizoaffective disorder

Exclusion Criteria:

• Current substance abuse
• History of epilepsy/seizures
• Head injury with loss of consciousness (>3 minutes)
• Taking warfarin or blood thinning medication
• Uncontrolled thyroid dysfunction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coenzyme Q10; 100mg CoQ10 capsule taken orally three times per day for 6 months	Dietary supplement: Coenzyme Q10; Other Names: Ubidecarenone; Ubiquinone Q10
Placebo Comparator: Placebo; Placebo capsule taken orally three times per day for 6 months	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline attention	Change from baseline attention as measured by Continuous Performance Test, identical pairs version (CPT-IP)	6 months post-supplementation initiation/Directly following study treatment period
Change from baseline working memory performance	Change from baseline working memory performance as measured by Cambridge Neuropsychological Test Automated Battery (CANTAB) spatial working memory task.	6 months post-supplementation initiation/Directly following study treatment period
Change from baseline working memory performance	Change from baseline working memory performance as measured by Letter Number Sequencing of Wechsler Memory Scale-III.	6 months post-supplementation initiation/Directly following study treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline processing speed	Change from baseline processing speed as measured by Verbal Fluency Task	6 months post-supplementation initiation/Directly following study treatment period
Change from baseline processing speed	Change from baseline processing speed as measured by Trail Making Task	6 months post-supplementation initiation/Directly following study treatment period
Change from baseline energy levels	Change from baseline energy levels as measured by Functional Assessment of Chronic Illness Therapy - fatigue scale. Higher scores on this scale (total score range: 0-52) indicate better outcome.	6 months post-supplementation initiation/Directly following study treatment period
Change from baseline depression levels	Change from baseline depression levels as measured by Beck's Depression Inventory II	6 months post-supplementation initiation/Directly following study treatment period
Change from baseline anxiety levels	Change from baseline anxiety levels as measured by Beck's Anxiety Inventory	6 months post-supplementation initiation/Directly following study treatment period
Change from baseline negative symptoms of avolition, asociality, blunted affect and alogia levels	Change from baseline negative symptoms of avolition, asociality, blunted affect and alogia levels as measured by Brief Negative Symptoms subscales	6 months post-supplementation initiation/Directly following study treatment period
Change from baseline blood pressure (systolic and diastolic)	Change from baseline blood pressure (systolic and diastolic)	6 months post-supplementation initiation/Directly following study treatment period
Change from baseline plasma CoQ10 levels	Change from baseline plasma CoQ10 levels	6 months post-supplementation initiation/Directly following study treatment period
Change from baseline mitochondrial function	Change from baseline mitochondrial function as measured by plasma lactate levels	6 months post-supplementation initiation/Directly following study treatment period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline self-reported quality of life	Change baseline self-reported quality of life (WHOQOL-Bref)	6 months post-supplementation initiation

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Collaborators: Royal Liverpool University Hospital; Liverpool John Moores University
• Investigators: Principal Investigator: Michael Gill, University of Dublin, Trinity College

Publications and helpful links

General Publications

• Maguire A, Mooney C, Flynn G, Ferguson Y, O'Keane V, O'Rourke D, McMonagle T, Heaton R, Phillips S, Hargreaves I, Gill M, Hargreaves A. No Effect of Coenzyme Q10 on Cognitive Function, Psychological Symptoms, and Health-related Outcomes in Schizophrenia and Schizoaffective Disorder: Results of a Randomized, Placebo-Controlled Trial. J Clin Psychopharmacol. 2021 Jan/Feb 01;41(1):53-57. doi: 10.1097/JCP.0000000000001330.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: June 21, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Actual): June 20, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: CRFSJ0087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No