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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03576911
• Other study ID #: CRFSJ0087
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: August 2019

Study information

• Verified date: June 2019
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Dietary Supplement:
• Coenzyme Q10

Other:
• Placebo

Locations

Country	Name	City	State
Ireland	Clinical Research Facility, St James's Hospital	Dublin

Sponsors (3)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	Liverpool John Moores University, Royal Liverpool University Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline self-reported quality of life	Change baseline self-reported quality of life (WHOQOL-Bref)	6 months post-supplementation initiation
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline plasma CoQ10 levels	Change from baseline plasma CoQ10 levels	6 months post-supplementation initiation/Directly following study treatment period
Secondary	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