Clinical trial NCT03576911: A Randomised Controlled Trial of Coenzyme Q10 in Patients With Schizophrenia and Schizoaffective Disorder
Official title: Coenzyme Q10 in the Amelioration of Cognitive Deficits and Symptoms in Schizophrenia and Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Liverpool John Moores University
name: Royal Liverpool University Hospital
First posted: 2018-07-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline attention
timeFrame: 6 months post-supplementation initiation/Directly following study treatment period
measure: Change from baseline working memory performance
timeFrame: 6 months post-supplementation initiation/Directly following study treatment period
measure: Change from baseline working memory performance
timeFrame: 6 months post-supplementation initiation/Directly following study treatment period
Secondary outcomes:
measure: Change from baseline processing speed
timeFrame: 6 months post-supplementation initiation/Directly following study treatment period
measure: Change from baseline processing speed
timeFrame: 6 months post-supplementation initiation/Directly following study treatment period
measure: Change from baseline energy levels
timeFrame: 6 months post-supplementation initiation/Directly following study treatment period
measure: Change from baseline depression levels
timeFrame: 6 months post-supplementation initiation/Directly following study treatment period
measure: Change from baseline anxiety levels
timeFrame: 6 months post-supplementation initiation/Directly following study treatment period
measure: Change from baseline negative symptoms of avolition, asociality, blunted affect and alogia levels
timeFrame: 6 months post-supplementation initiation/Directly following study treatment period
measure: Change from baseline blood pressure (systolic and diastolic)
timeFrame: 6 months post-supplementation initiation/Directly following study treatment period
measure: Change from baseline plasma CoQ10 levels
timeFrame: 6 months post-supplementation initiation/Directly following study treatment period
measure: Change from baseline mitochondrial function
timeFrame: 6 months post-supplementation initiation/Directly following study treatment period
Other outcomes:
measure: Change from baseline self-reported quality of life
timeFrame: 6 months post-supplementation initiation
Locations:
city: Dublin
country: Ireland
facility: Clinical Research Facility, St James's Hospital
Study officials:
affiliation: University of Dublin, Trinity College
name: Michael Gill
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.