NCT03576911

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

June 20, 2019

Status Verified

June 1, 2019

Enrollment Period

2.7 years

First QC Date

June 21, 2018

Last Update Submit

June 18, 2019

Conditions

SchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • Change from baseline processing speed

    6 months post-supplementation initiation/Directly following study treatment period

  • Change from baseline processing speed

    6 months post-supplementation initiation/Directly following study treatment period

  • Change from baseline energy levels

    6 months post-supplementation initiation/Directly following study treatment period

  • Change from baseline depression levels

    6 months post-supplementation initiation/Directly following study treatment period

  • Change from baseline anxiety levels

    6 months post-supplementation initiation/Directly following study treatment period

  • +4 more secondary outcomes

Other Outcomes (1)

  • Change from baseline self-reported quality of life

    6 months post-supplementation initiation

Study Arms (2)

Coenzyme Q10

EXPERIMENTAL

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

Dietary Supplement: Coenzyme Q10

Placebo

PLACEBO COMPARATOR

Placebo capsule taken orally three times per day for 6 months

Other: Placebo

Interventions

Coenzyme Q10DIETARY_SUPPLEMENT
Also known as: Ubiquinone Q10, Ubidecarenone
Coenzyme Q10
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of schizophrenia or schizoaffective disorder

You may not qualify if:

  • Current substance abuse
  • History of epilepsy/seizures
  • Head injury with loss of consciousness (\>3 minutes)
  • Taking warfarin or blood thinning medication
  • Uncontrolled thyroid dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Facility, St James's Hospital

Dublin, Ireland

Location

Related Publications (1)

  • 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.

    PMID: 33347024DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Michael Gill

    University of Dublin, Trinity College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 5, 2018

Study Start

November 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

June 20, 2019

Record last verified: 2019-06

Locations

IE(1)