A Randomised Controlled Trial of Coenzyme Q10 in Patients With Schizophrenia and Schizoaffective Disorder
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Coenzyme Q10 100mg CoQ10 capsule taken orally three times per day for 6 months |
Dietary Supplement: Coenzyme Q10
Other Names:
|
| Placebo Comparator: Placebo Placebo capsule taken orally three times per day for 6 months |
Other: Placebo
|
Outcome Measures
Primary Outcome Measures
- 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 Cambridge Neuropsychological Test Automated Battery (CANTAB) spatial working memory task.
- 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
- Change from baseline processing speed [6 months post-supplementation initiation/Directly following study treatment period]
Change from baseline processing speed as measured by Verbal Fluency Task
- 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.
- 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
Other Outcome Measures
- Change from baseline self-reported quality of life [6 months post-supplementation initiation]
Change baseline self-reported quality of life (WHOQOL-Bref)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Research Facility, St James's Hospital | Dublin | Ireland |
Sponsors and Collaborators
- University of Dublin, Trinity College
- Liverpool John Moores University
- Royal Liverpool University Hospital
Investigators
- Principal Investigator: Michael Gill, University of Dublin, Trinity College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRFSJ0087