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

Study Overview
=================
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.

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

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: Coenzyme Q10
* Other: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coenzyme Q10<br>100mg CoQ10 capsule taken orally three times per day for 6 months | Dietary Supplement: Coenzyme Q10<br> <br> * Other names: Ubidecarenone;|
| Placebo Comparator: Placebo<br>Placebo capsule taken orally three times per day for 6 months | Other: Placebo<br> <br> |

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 |