An interventional study of Coenzyme Q10 and Placebo in Schizophrenia and Schizoaffective Disorder, sponsored by University of Dublin, Trinity College. Status unknown at 1 site in Ireland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-20.
Sponsored by University of Dublin, Trinity College · Not applicable, Interventional, and Treatment
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.
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 72 is close to the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →University of Dublin, Trinity College is the lead sponsor of 72 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
100mg CoQ10 capsule taken orally three times per day for 6 months
Dietary Supplement: Coenzyme Q10
Placebo capsule taken orally three times per day for 6 months
Other: Placebo
Also known as: Ubiquinone Q10, Ubidecarenone
Change from baseline attention
Change from baseline attention as measured by Continuous Performance Test, identical pairs version (CPT-IP)
Time frame: 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.
Time frame: 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.
Time frame: 6 months post-supplementation initiation/Directly following study treatment period
Change from baseline processing speed
Change from baseline processing speed as measured by Verbal Fluency Task
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 6 months post-supplementation initiation/Directly following study treatment period
Change from baseline plasma CoQ10 levels
Change from baseline plasma CoQ10 levels
Time frame: 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
Time frame: 6 months post-supplementation initiation/Directly following study treatment period
Change from baseline self-reported quality of life
Change baseline self-reported quality of life (WHOQOL-Bref)
Time frame: 6 months post-supplementation initiation
Plan to share: Undecided
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University of Dublin, Trinity College