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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Coenzyme Q10
Placebo
Sponsored by
University of Dublin, Trinity College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Facility, St James's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Coenzyme Q10

Placebo

Arm Description

100mg CoQ10 capsule taken orally three times per day for 6 months

Placebo capsule taken orally three times per day for 6 months

Outcomes

Primary Outcome Measures

Change from baseline attention
Change from baseline attention as measured by Continuous Performance Test, identical pairs version (CPT-IP)
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.
Change from baseline working memory performance
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
Change from baseline processing speed as measured by Verbal Fluency Task
Change from baseline processing speed
Change from baseline processing speed as measured by Trail Making Task
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.
Change from baseline depression levels
Change from baseline depression levels as measured by Beck's Depression Inventory II
Change from baseline anxiety levels
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
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)
Change from baseline blood pressure (systolic and diastolic)
Change from baseline plasma CoQ10 levels
Change from baseline plasma CoQ10 levels
Change from baseline mitochondrial function
Change from baseline mitochondrial function as measured by plasma lactate levels

Full Information

First Posted
June 21, 2018
Last Updated
June 18, 2019
Sponsor
University of Dublin, Trinity College
Collaborators
Liverpool John Moores University, Royal Liverpool University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03576911
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dublin, Trinity College
Collaborators
Liverpool John Moores University, Royal Liverpool University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coenzyme Q10
Arm Type
Experimental
Arm Description
100mg CoQ10 capsule taken orally three times per day for 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule taken orally three times per day for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Coenzyme Q10
Other Intervention Name(s)
Ubiquinone Q10, Ubidecarenone
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline attention
Description
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
Title
Change from baseline working memory performance
Description
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
Title
Change from baseline working memory performance
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline processing speed
Description
Change from baseline processing speed as measured by Verbal Fluency Task
Time Frame
6 months post-supplementation initiation/Directly following study treatment period
Title
Change from baseline processing speed
Description
Change from baseline processing speed as measured by Trail Making Task
Time Frame
6 months post-supplementation initiation/Directly following study treatment period
Title
Change from baseline energy levels
Description
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
Title
Change from baseline depression levels
Description
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
Title
Change from baseline anxiety levels
Description
Change from baseline anxiety levels as measured by Beck's Anxiety Inventory
Time Frame
6 months post-supplementation initiation/Directly following study treatment period
Title
Change from baseline negative symptoms of avolition, asociality, blunted affect and alogia levels
Description
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
Title
Change from baseline blood pressure (systolic and diastolic)
Description
Change from baseline blood pressure (systolic and diastolic)
Time Frame
6 months post-supplementation initiation/Directly following study treatment period
Title
Change from baseline plasma CoQ10 levels
Description
Change from baseline plasma CoQ10 levels
Time Frame
6 months post-supplementation initiation/Directly following study treatment period
Title
Change from baseline mitochondrial function
Description
Change from baseline mitochondrial function as measured by plasma lactate levels
Time Frame
6 months post-supplementation initiation/Directly following study treatment period
Other Pre-specified Outcome Measures:
Title
Change from baseline self-reported quality of life
Description
Change baseline self-reported quality of life (WHOQOL-Bref)
Time Frame
6 months post-supplementation initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gill
Organizational Affiliation
University of Dublin, Trinity College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Facility, St James's Hospital
City
Dublin
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33347024
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.
Results Reference
derived

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

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