Mental DisorderNCT04842461
Mental Health, Addictions and Biomarkers in High Athletes Performance
An observational study of Mental Disorder and Anxiety, run by Cardenal Herrera University at 2 sites in Spain.
Trial summary
Sport is a privileged area to promote socialization and health values, such as companionship; a healthy lifestyle; cooperation to achieve common goals, and justice, rejecting unjustified advantages in competition. The concept of fair play is on which the development of those values pivots. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Mental Disorder, Anxiety, Depression
- How many people
- 306 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Oct 2020to 31 Jul 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 40 years
- All sexes
- Adult
Study population: Elite football players from Spanish football league
Who may be able to join
- active athletes in the elite soccer competition from the Villarreal CF, who agree to be included in the study by signing an informed consent and who have a health profile made by the club's Medical Service.
Who cannot join
- athletes who are transferred to other clubs during the study period.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Villarreal CF
Ciudad Real, Castellón, 12540
Villarreal CF
Villarreal, Castellón, 12540
About this study
Official title: Presence of Psychopathy and Antisocial Personality Disorder as Well as Genetic Biomarkers and the Inhibition-prepulse Endophenotype in Elite Athletes
Sport is a privileged area to promote socialization and health values, such as companionship; a healthy lifestyle; cooperation to achieve common goals, and justice, rejecting unjustified advantages in competition. The concept of fair play is on which the development of those values pivots. From a holistic perspective, it is possible to define fair play, not only as a way to participate but also as a way of projecting people in life with values, assuming a set of behaviors that enhance a healthy and respectful sporting experience with opponents, the companions, the spectators, the referees and all the agents that take part in the sport practice.
Read the detailed description
Sport is a privileged area to promote socialization and health values, such as companionship; a healthy lifestyle; cooperation to achieve common goals, and justice, rejecting unjustified advantages in competition. The concept of fair play is on which the development of those values pivots. From a holistic perspective, it is possible to define fair play, not only as a way to participate but also as a way of projecting people in life with values, assuming a set of behaviors that enhance a healthy and respectful sporting experience with opponents, the companions, the spectators, the referees and all the agents that take part in the sport practice.
Since 2018, joint actions have been carried out with the Villarreal de Fútbol Club, within the framework of the ENDAVANT agreement. Within these actions, it is proposed to develop different lines of research on sport and health. Within these lines, one of special relevance is that related to the risk of consumption of illicit substances and / or behavioral addictions, in elite athletes, since they are subjected to intense training days and stress situations derived from the demands of performance of professional competitive activity. On the other hand, recently published behavioral studies show that athletes who practice non-contact sports have a greater capacity to identify and assess emotions than athletes who practice contact sports and than those who practice contact sports show higher levels of physical aggression or verbal, and hostility or anger, than athletes who practice individual and non-contact sports.
- Conditions
- Mental Disorder, Anxiety, Depression, Substance Abuse, Pathological Gambling
- Keywords
- mental disorder, gambling, despression, anxiety
- Medical subject headings
- Mental Disorders, Anxiety Disorders, Depression, Substance-Related Disorders, Gambling
What is being measured
The primary outcome is the main question the study is designed to answer.
Common drugs
Describe the consumption of common drugs in elite athletes.
Measured: 2 years
Identify other mental disorders
Identify other mental disorders differents than addictions and psychopathy in elite athletes.
Measured: 2 years
Explore the consumption of new psychoactive substances
Explore the consumption of new psychoactive substances in elite athletes
Measured: 2 years
Pathological gambling
Describe the study of behavioral addictions and video game addiction in elite athletes.
Measured: 2 years
Mental disorders
Describe the presence of psychopathy and antisocial personality disorder
Measured: 2 years
Genetic biomarkers
Describe genetic biomarkers endophenotype in elite athletes.
Measured: 2 years
Dopping
Describe new dopping substances in elite atheletes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start15 Oct 2020
- Primary completion10 Mar 2021
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 306 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- Villarreal CF
- Responsible party
- Principal investigator, Isabel Almodóvar Fernández, Cardenal Herrera University
- Investigators
- Adolfo Muñoz Macho, MD, Study chair, Medical Services of Villarreal CF SAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842461
- Sponsor's protocol ID
- MHS
- Status last verified
- Feb 2023
- First submitted
- 7 Apr 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of Psychopathy and Antisocial Personality Disorder as Well as Genetic Biomarkers and the Inhibition-prepulse Endophenotype in Elite Athletes
- ClinicalTrials.gov ID
- NCT04842461
- Acronym / sponsor ID
- MHS
- Conditions
- Mental Disorder, Anxiety, Depression, Substance Abuse, Pathological Gambling
- Keywords
- mental disorder, gambling, despression, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- Villarreal CF
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 13 Apr 2021 (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.
Sport is a privileged area to promote socialization and health values, such as companionship; a healthy lifestyle; cooperation to achieve common goals, and justice, rejecting unjustified advantages in competition. The concept of fair play is on which the development of those values pivots. From a holistic perspective, it is possible to define fair play, not only as a way to participate but also as a way of projecting people in life with values, assuming a set of behaviors that enhance a healthy and respectful sporting experience with opponents, the companions, the spectators, the referees and all the agents that take part in the sport practice.
Detailed description
Sport is a privileged area to promote socialization and health values, such as companionship; a healthy lifestyle; cooperation to achieve common goals, and justice, rejecting unjustified advantages in competition. The concept of fair play is on which the development of those values pivots. From a holistic perspective, it is possible to define fair play, not only as a way to participate but also as a way of projecting people in life with values, assuming a set of behaviors that enhance a healthy and respectful sporting experience with opponents, the companions, the spectators, the referees and all the agents that take part in the sport practice.
Since 2018, joint actions have been carried out with the Villarreal de Fútbol Club, within the framework of the ENDAVANT agreement. Within these actions, it is proposed to develop different lines of research on sport and health. Within these lines, one of special relevance is that related to the risk of consumption of illicit substances and / or behavioral addictions, in elite athletes, since they are subjected to intense training days and stress situations derived from the demands of performance of professional competitive activity. On the other hand, recently published behavioral studies show that athletes who practice non-contact sports have a greater capacity to identify and assess emotions than athletes who practice contact sports and than those who practice contact sports show higher levels of physical aggression or verbal, and hostility or anger, than athletes who practice individual and non-contact sports.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- Elite football players from Spanish football league
Key inclusion criteria (1 listed)
- active athletes in the elite soccer competition from the Villarreal CF, who agree to be included in the study by signing an informed consent and who have a health profile made by the club's Medical Service.
Key exclusion criteria (1 listed)
- athletes who are transferred to other clubs during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Common drugs
Time frame: 2 years
Describe the consumption of common drugs in elite athletes.
Identify other mental disorders
Time frame: 2 years
Identify other mental disorders differents than addictions and psychopathy in elite athletes.
Explore the consumption of new psychoactive substances
Time frame: 2 years
Explore the consumption of new psychoactive substances in elite athletes
Pathological gambling
Time frame: 2 years
Describe the study of behavioral addictions and video game addiction in elite athletes.
Mental disorders
Time frame: 2 years
Describe the presence of psychopathy and antisocial personality disorder
Genetic biomarkers
Time frame: 2 years
Describe genetic biomarkers endophenotype in elite athletes.
Dopping
Time frame: 2 years
Describe new dopping substances in elite atheletes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
Related trials for Mental Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Adolfo Muñoz Macho, MD study chair
Medical Services of Villarreal CF SAD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorder and Anxiety, run by Cardenal Herrera University at 2 sites in Spain.
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 1 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: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Common drugs (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2023.