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

Not Applicable

• Conditions: Schizoaffective Disorder; Schizophrenia
• Interventions: Dietary Supplement: Coenzyme Q10; Other: Placebo

• Registration Number: NCT03576911
• Lead Sponsor: University of Dublin, Trinity College

Brief Summary

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.

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 Timeline

• Study Start: 2016-11
• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-06-21
• Study First Posted: 2018-07-05
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-20
• Primary Completion: 2019-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Clinical diagnosis of schizophrenia or schizoaffective disorder

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coenzyme Q10	Coenzyme Q10	100mg CoQ10 capsule taken orally three times per day for 6 months
Placebo	Placebo	Placebo capsule taken orally three times per day for 6 months

Primary Outcome Measures

Name	Time	Method
Change from baseline attention	6 months post-supplementation initiation/Directly following study treatment period	Change from baseline attention as measured by Continuous Performance Test, identical pairs version (CPT-IP)
Change from baseline working memory performance	6 months post-supplementation initiation/Directly following study treatment period	Change from baseline working memory performance as measured by Letter Number Sequencing of Wechsler Memory Scale-III.

Secondary Outcome Measures

Name	Time	Method
Change from baseline depression levels	6 months post-supplementation initiation/Directly following study treatment period	Change from baseline depression levels as measured by Beck's Depression Inventory II
Change from baseline anxiety levels	6 months post-supplementation initiation/Directly following study treatment period	Change from baseline anxiety levels as measured by Beck's Anxiety Inventory
Change from baseline negative symptoms of avolition, asociality, blunted affect and alogia levels	6 months post-supplementation initiation/Directly following study treatment period	Change from baseline negative symptoms of avolition, asociality, blunted affect and alogia levels as measured by Brief Negative Symptoms subscales
Change from baseline blood pressure (systolic and diastolic)	6 months post-supplementation initiation/Directly following study treatment period	Change from baseline blood pressure (systolic and diastolic)
Change from baseline plasma CoQ10 levels	6 months post-supplementation initiation/Directly following study treatment period	Change from baseline plasma CoQ10 levels
Change from baseline mitochondrial function	6 months post-supplementation initiation/Directly following study treatment period	Change from baseline mitochondrial function as measured by plasma lactate levels
Change from baseline processing speed	6 months post-supplementation initiation/Directly following study treatment period	Change from baseline processing speed as measured by Trail Making Task
Change from baseline energy levels	6 months post-supplementation initiation/Directly following study treatment period	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.

Trial Locations

Locations (1)

Clinical Research Facility, St James's Hospital; 🇮🇪 Dublin, Ireland