SchizophreniaNCT03576911
A Randomised Controlled Trial of Coenzyme Q10 in Patients With Schizophrenia and Schizoaffective Disorder
A study testing Coenzyme Q10 in people with Schizophrenia and Schizoaffective Disorder, run by University of Dublin, Trinity College at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Coenzyme Q10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteIreland
- Study dates
- Nov 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of schizophrenia or schizoaffective disorder
Who cannot join
- Current substance abuse
- History of epilepsy/seizures
- Head injury with loss of consciousness (>3 minutes)
- Taking warfarin or blood thinning medication
- Uncontrolled thyroid dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coenzyme Q10 in the Amelioration of Cognitive Deficits and Symptoms in Schizophrenia and Schizoaffective Disorder
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Coenzyme Q10, Placebo
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Dietary supplement
Also called Ubiquinone Q10, Ubidecarenone
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 | Experimental | 100mg CoQ10 capsule taken orally three times per day for 6 months Receives: Dietary Supplement: Coenzyme Q10 |
| Placebo | Placebo comparator | Placebo capsule taken orally three times per day for 6 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline attention
Change from baseline attention as measured by Continuous Performance Test, identical pairs version (CPT-IP)
Measured: 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.
Measured: 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.
Measured: 6 months post-supplementation initiation/Directly following study treatment period
Secondary outcomes (9)
Change from baseline processing speed
Change from baseline processing speed as measured by Verbal Fluency Task
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 6 months post-supplementation initiation/Directly following study treatment period
Change from baseline plasma CoQ10 levels
Change from baseline plasma CoQ10 levels
Measured: 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
Measured: 6 months post-supplementation initiation/Directly following study treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study startNov 2016
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool John Moores University, Royal Liverpool University Hospital
- Responsible party
- Principal investigator, Michael Gill, MD, University of Dublin, Trinity College
- Investigators
- Michael Gill, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576911
- Sponsor's protocol ID
- CRFSJ0087
- Status last verified
- Jun 2019
- First submitted
- 21 Jun 2018
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33347024
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coenzyme Q10 in the Amelioration of Cognitive Deficits and Symptoms in Schizophrenia and Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT03576911
- Acronym / sponsor ID
- CRFSJ0087
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Liverpool John Moores University, Royal Liverpool University Hospital
- Study start
- Nov 2016 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 | Experimental | Dietary Supplement: Coenzyme Q10100mg CoQ10 capsule taken orally three times per day for 6 months |
| Placebo | Placebo comparator | Other: PlaceboPlacebo capsule taken orally three times per day for 6 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of schizophrenia or schizoaffective disorder
Key exclusion criteria (5 listed)
- Current substance abuse
- History of epilepsy/seizures
- Head injury with loss of consciousness (>3 minutes)
- Taking warfarin or blood thinning medication
- Uncontrolled thyroid dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10Also: Ubiquinone Q10, Ubidecarenone | Dietary supplement | Coenzyme Q10 |
| Placebo | Other | Placebo |
Primary outcome
Change from baseline attention
Time frame: 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
Time frame: 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
Time frame: 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.
9 secondary outcomes
Change from baseline processing speed
Time frame: 6 months post-supplementation initiation/Directly following study treatment period
Change from baseline processing speed
Time frame: 6 months post-supplementation initiation/Directly following study treatment period
Change from baseline energy levels
Time frame: 6 months post-supplementation initiation/Directly following study treatment period
Change from baseline depression levels
Time frame: 6 months post-supplementation initiation/Directly following study treatment period
Change from baseline anxiety levels
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
Time frame: 6 months post-supplementation initiation/Directly following study treatment period
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
Time frame: 6 months post-supplementation initiation/Directly following study treatment period
Change from baseline mitochondrial function
Time frame: 6 months post-supplementation initiation/Directly following study treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Derived from this study: PubMed 33347024Maguire 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Gill principal investigator
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 in people with Schizophrenia and Schizoaffective Disorder, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline attention (time frame: 6 months post-supplementation initiation/Directly following study treatment period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03576911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.