SchizophreniaCOPUSNCT03409393
Feasibility and Relevance of High-Intensity Functional Training in Patients With First-Episode Psychosis
A study testing The COPUS intervention in people with Schizophrenia and Schizotypal Disorder, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of the COPUS study is to investigate, whether it is possible to recruit and retain young people with first-episode psychosis, to an 8 week supervised High-Intensity Functional Training intervention (HIFT) (i.e. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia, Schizotypal Disorder, First Episode Psychosis
- What is being tested?
- The COPUS intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Jan 2018to 1 Aug 2018
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 35 years
- Diagnosed with Schizophrenia or Schizotypal disorders
- Undergoing OPUS treatment for at least 6 months or stabilized medical anti-psychotic treatment
- Danish speaking
Who cannot join
- Physical contraindications for physical activity
- Pregnant (self-reported)
- Unable to give adequately informed consent
- Mentally disabled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Relevance of High-Intensity Functional Training in Patients Undergoing Specialised Early Intervention Treatment for First-Episode Psychosis
The aim of the COPUS study is to investigate, whether it is possible to recruit and retain young people with first-episode psychosis, to an 8 week supervised High-Intensity Functional Training intervention (HIFT) (i.e. COPUS Intervention) and to investigate if oxygen uptake, body composition and physical function improves following participation in the intervention.
Read the detailed description
The introduction of specialized early intervention (SEI) is stated to be the most successful recent addition to the treatment of schizophrenia and other psychotic illnesses. In Denmark, SEI teams called OPUS, offer early intervention treatment (i.e. OPUS treatment) to young patients between 18 and 35 years with first-episode psychosis. The OPUS treatment consists of three main pillars: modified assertive treatment, family involvement, and social skill training. OPUS treatment is delivered via multidisciplinary teams including psychiatrists, psychologists, nurses, social workers, physiotherapists, and vocational therapists.
Despite considerable progress in treatment of schizophrenia, people diagnosed with schizophrenia live significantly shorter lives, compared to the rest of the population. The higher mortality rate can be partly explained by an increased risk of cardiovascular disease, including metabolic syndrome, which may be documented already in the first months after start of medical anti-psychotic treatment. It is widely acknowledged that physical activity constitutes a cornerstone in the prevention of cardiovascular disease and metabolic syndrome. Therefore, despite the influence of non-modifiable factors (e.g. genetics), it is reasonable to assume that physical activity can promote health and prevent somatic disease in people diagnosed with schizophrenia.
However, currently, physical activity is not included in early intervention treatment of schizophrenia. Moreover, people with schizophrenia may experience anxiety, loss of motivation, apathy and social isolation, which can constitute significant barriers for adherence to physical activity. Existing knowledge in relation to physical activity behaviour change and adoption is therefore difficult to transfer directly to people with schizophrenia. Development and testing of new initiatives, which can be integrated into clinical practice, and offered complementary to SEI are thus warranted.
Against this background, the aim of the current study (called the COPUS study) is to investigate, whether it is possible to recruit and retain young people with first-episode psychosis, to an 8-weeks supervised High-Intensity Functional Training (HIFT) intervention (i.e. COPUS intervention) and to investigate if oxygen uptake, body composition and physical function changes following participation in the COPUS intervention. The study is organized as a randomized mixed methods feasibility study.
The COPUS intervention is offered in a private fitness centre in the local community. The intervention contains three training sessions of one hour duration per week, with the recommendation to the participants, to take part in at least two sessions per week.
The investigators aim to include 30 participants whom will be randomly assigned (1:1) to either an intervention group receiving the COPUS intervention plus usual care (i.e. standard OPUS treatment) or a control group including only receiving usual care (i.e. standard OPUS treatment). Participants allocated to the control group are offered the COPUS intervention after eight weeks.
The design and choice of methods reflect the complexity of the intervention (combination of social and physical elements that are difficult to control and isolate) and the desire to establish a scientifically informed basis for a subsequent, up-scaled, pragmatic randomized multicentre study.
- Conditions
- Schizophrenia, Schizotypal Disorder, First Episode Psychosis, Psychotic Disorders, Schizoaffective Disorder
- Being tested
- The COPUS intervention, Usual Care (OPUS treatment)
- Keywords
- Human, Denmark, Adult, Adolescent, Young Adult, Male, Female, Physical Activity, Maximum Oxygen Consumption, Resistance Training, High-Intensity Functional Training, Aerobic Exercise, Motivation, Feasibility, Relevance, Health Behavior
- Medical subject headings
- Schizophrenia, Schizotypal Personality Disorder, Psychotic Disorders, Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The COPUS interventionOther
The COPUS intervention consists of 8 weeks of High-Intensity Functional Training (HIFT). The frequency of the training is 3 sessions per week and the duration is one hour per session. The intervention is group-based and supervised. Each training session includes warm-up (15 min), followed by 30 minutes of HIFT based on a range of varied functional exercises, including elements of strength training and aerobic exercise. The sessions are supervised by a trained physiotherapist and exercise physiologist supported by 2 two trained bachelor students in Sports Science.
Usual Care (OPUS treatment)Other
Usual care include specialised early intervention treatment (OPUS treatment) and consists of three main pillars: modified assertive treatment, family involvement, and social skill training. OPUS treatment is delivered via multidisciplinary teams include psychiatrists, psychologists, nurses, social workers, physiotherapists, and vocational therapists. All team members, except for the psychiatrist, function as case managers. The ratio of patients to case managers must not exceed 12:1.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The COPUS intervention plus usual care (OPUS treatment). Receives: Other: The COPUS intervention; Other: Usual Care (OPUS treatment) |
| Control Group | Other | Usual care (OPUS treatment). Receives: Other: Usual Care (OPUS treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of changes in Physical Fitness (VO2max)
Assessed by the maximum amount of oxygen the body can utilize during a specified period of intense exercise.
Measured: Change from Baseline Physical Fitness (VO2max) at 2 months.
Recruitment Rate
Registration of patients enrolled in the study compared to the total number of eligible patients.
Measured: Registration of recruitment occurs in the 4 weeks prior to the baseline tests.
Retention Rate
Registration of the participants attendance in the High-Intensity Functional Training compared with the number of possible training sessions during the period.
Measured: From baseline up to 4 months.
Secondary outcomes (11)
Assessment of changes in body weight
The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining body weight.
Measured: Change from Baseline Body Weight at 2 months.
Assessment of changes in fat percentage
The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining fat percentage.
Measured: Change from Baseline Fat Percentage at 2 months.
Assessment of changes in bone mass
The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining bone mass.
Measured: Change from Baseline Bone Mass at 2 months.
Assessment of changes in muscle mass
The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining muscle mass.
Measured: Change from Baseline Muscle Mass at 2 months.
Assessment of changes in Visceral Fat
The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining visceral fat.
Measured: Change from Baseline Visceral Fat at 2 months.
Assessment of changes in Resting Blood Pressure
The participants' Resting Blood Pressure are tested according to the American Heart Association practice guidelines for blood pressure Measurement.
Measured: Change form Baseline Resting Blood Pressure at 2 months.
Assessment of changes in countermovement jump height
Determination of potential changes in countermovement jump height measured using the non-invasive Optojump system (www.optojump.com)
Measured: Change form Baseline Jump Height at 2 months.
Assessment of changes in Leg Muscle Strength
Determination of potential changes in leg muscle strength by the non-invasive 30-Second Chair Stand test. The test measures how many times the participant can reach a full standing position from a sitting position in 30 seconds. Score range from 0 and up with a higher score being considered as a better outcome.
Measured: Change form Baseline Leg Muscle Strength at 2 months.
Assessment of changes in Hand Grip Strength
Determination of potential changes in grip strength measured quantitatively using a hand dynamometer.
Measured: Change form Baseline Hand Grip Strength at 2 months.
Assessment of changes in Balance
Determination of potential changes in balance using the Flamingo Balance Test. The participant stands on a 3 centimeter wide beam while holding the instructors hand. The tests then measures how many times the participant loses balance in 60 seconds.Score range from 0 and up with a lower score being considered as a better outcome.
Measured: Change form Baseline balance at 2 months.
Assessment of changes in Self-reported Physical Activity Behavior
Assesment of changes in self-reported physical activity behaviour using the Physical Activity Scale (PAS). The PAS measures self-reported amount of time spent on different physical activities, such as sports, work, and leisure time during 24 hours on an average weekday. The activities are organized in nine different metabolic equivalent (MET) levels ranging from sleep/rest (0.9 METs) to high-intensity physical activities (>6 METs). MET is the Metabolic Equivalent of Task and is a physiological measure expressing the energy cost of physical activities and is defined as the ratio of metabolic rate (and therefore the rate of energy consumption) during a specific physical activity to a reference metabolic rate. Therefore, higher MET scores in the Physical Activity Scale indicates a better outcome than lower scores.
Measured: Change from Baseline Physical Activity Behaviour at 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start22 Jan 2018
- Primary completion20 Jun 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The participants will be randomly assigned (1:1) to either an Intervention Group that in the initial study phase (week 0-8) receives the COPUS intervention plus usual care (i.e. OPUS treatment) or to a Control Group that only receives usual care in the initial phase. In the second phase of the study (week 8-16), participants allocated to the control group are offered the COPUS intervention.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Responsible party
- Principal investigator, Julie Midtgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Julie Midtgaard, Ph.D., Principal investigator, The University Hospitals Centre for Health Research (UCSF) / Copenhagen University Hospital (Rigshospitalet)Helle Schnor, Ph.D., Study director, Mental health services in the Capital Region of Denmark, Psychiatric Center Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409393
- Sponsor's protocol ID
- COPUS
- Other IDs
- 119481
- Acronym
- COPUS
- Status last verified
- Sep 2018
- First submitted
- 4 Jan 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Midtgaard J, Schnor H, Bjerre ED, Jespersen T, Jelsoe N, Frolund N, Seier S, Ronbog JW, Nordsborg NB, Ebdrup BH. Exercise training complementary to specialised early intervention in patients with first-episode psychosis: a feasibility randomised trial. Pilot Feasibility Stud. 2021 Aug 19;7(1):162. doi: 10.1186/s40814-021-00900-5.
PubMed 34412705Larsen LQ, Schnor H, Tersbol BP, Ebdrup BH, Nordsborg NB, Midtgaard J. The impact of exercise training complementary to early intervention in patients with first-episode psychosis: a qualitative sub-study from a randomized controlled feasibility trial. BMC Psychiatry. 2019 Jun 21;19(1):192. doi: 10.1186/s12888-019-2179-3.
PubMed 31226959
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Relevance of High-Intensity Functional Training in Patients Undergoing Specialised Early Intervention Treatment for First-Episode Psychosis
- ClinicalTrials.gov ID
- NCT03409393
- Acronym / sponsor ID
- COPUS / COPUS
- Conditions
- Schizophrenia, Schizotypal Disorder, First Episode Psychosis, Psychotic Disorders, Schizoaffective Disorder
- Keywords
- Human, Denmark, Adult, Adolescent, Young Adult, Male, Female, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 24 Jan 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 aim of the COPUS study is to investigate, whether it is possible to recruit and retain young people with first-episode psychosis, to an 8 week supervised High-Intensity Functional Training intervention (HIFT) (i.e. COPUS Intervention) and to investigate if oxygen uptake, body composition and physical function improves following participation in the intervention.
Detailed description
The introduction of specialized early intervention (SEI) is stated to be the most successful recent addition to the treatment of schizophrenia and other psychotic illnesses. In Denmark, SEI teams called OPUS, offer early intervention treatment (i.e. OPUS treatment) to young patients between 18 and 35 years with first-episode psychosis. The OPUS treatment consists of three main pillars: modified assertive treatment, family involvement, and social skill training. OPUS treatment is delivered via multidisciplinary teams including psychiatrists, psychologists, nurses, social workers, physiotherapists, and vocational therapists.
Despite considerable progress in treatment of schizophrenia, people diagnosed with schizophrenia live significantly shorter lives, compared to the rest of the population. The higher mortality rate can be partly explained by an increased risk of cardiovascular disease, including metabolic syndrome, which may be documented already in the first months after start of medical anti-psychotic treatment. It is widely acknowledged that physical activity constitutes a cornerstone in the prevention of cardiovascular disease and metabolic syndrome. Therefore, despite the influence of non-modifiable factors (e.g. genetics), it is reasonable to assume that physical activity can promote health and prevent somatic disease in people diagnosed with schizophrenia.
However, currently, physical activity is not included in early intervention treatment of schizophrenia. Moreover, people with schizophrenia may experience anxiety, loss of motivation, apathy and social isolation, which can constitute significant barriers for adherence to physical activity. Existing knowledge in relation to physical activity behaviour change and adoption is therefore difficult to transfer directly to people with schizophrenia. Development and testing of new initiatives, which can be integrated into clinical practice, and offered complementary to SEI are thus warranted.
Against this background, the aim of the current study (called the COPUS study) is to investigate, whether it is possible to recruit and retain young people with first-episode psychosis, to an 8-weeks supervised High-Intensity Functional Training (HIFT) intervention (i.e. COPUS intervention) and to investigate if oxygen uptake, body composition and physical function changes following participation in the COPUS intervention. The study is organized as a randomized mixed methods feasibility study.
The COPUS intervention is offered in a private fitness centre in the local community. The intervention contains three training sessions of one hour duration per week, with the recommendation to the participants, to take part in at least two sessions per week.
The investigators aim to include 30 participants whom will be randomly assigned (1:1) to either an intervention group receiving the COPUS intervention plus usual care (i.e. standard OPUS treatment) or a control group including only receiving usual care (i.e. standard OPUS treatment). Participants allocated to the control group are offered the COPUS intervention after eight weeks.
The design and choice of methods reflect the complexity of the intervention (combination of social and physical elements that are difficult to control and isolate) and the desire to establish a scientifically informed basis for a subsequent, up-scaled, pragmatic randomized multicentre study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants will be randomly assigned (1:1) to either an Intervention Group that in the initial study phase (week 0-8) receives the COPUS intervention plus usual care (i.e. OPUS treatment) or to a Control Group that only receives usual care in the initial phase. In the second phase of the study (week 8-16), participants allocated to the control group are offered the COPUS intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: The COPUS intervention, Other: Usual Care (OPUS treatment)The COPUS intervention plus usual care (OPUS treatment). |
| Control Group | Other | Other: Usual Care (OPUS treatment)Usual care (OPUS treatment). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 35 years
- Diagnosed with Schizophrenia or Schizotypal disorders
- Undergoing OPUS treatment for at least 6 months or stabilized medical anti-psychotic treatment
- Danish speaking
Key exclusion criteria (4 listed)
- Physical contraindications for physical activity
- Pregnant (self-reported)
- Unable to give adequately informed consent
- Mentally disabled
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 |
|---|---|---|
| The COPUS interventionThe COPUS intervention consists of 8 weeks of High-Intensity Functional Training (HIFT). The frequency of the training is 3 sessions per week and the duration is one hour per session. The intervention is group-based and supervised. Each training session includes warm-up (15 min), followed by 30 minutes of HIFT based on a range of varied functional exercises, including elements of strength training and aerobic exercise. The sessions are supervised by a trained physiotherapist and exercise physiologist supported by 2 two trained bachelor students in Sports Science. | Other | Intervention Group |
| Usual Care (OPUS treatment)Usual care include specialised early intervention treatment (OPUS treatment) and consists of three main pillars: modified assertive treatment, family involvement, and social skill training. OPUS treatment is delivered via multidisciplinary teams include psychiatrists, psychologists, nurses, social workers, physiotherapists, and vocational therapists. All team members, except for the psychiatrist, function as case managers. The ratio of patients to case managers must not exceed 12:1. | Other | Control Group, Intervention Group |
Primary outcome
Assessment of changes in Physical Fitness (VO2max)
Time frame: Change from Baseline Physical Fitness (VO2max) at 2 months.
Assessed by the maximum amount of oxygen the body can utilize during a specified period of intense exercise.
Recruitment Rate
Time frame: Registration of recruitment occurs in the 4 weeks prior to the baseline tests.
Registration of patients enrolled in the study compared to the total number of eligible patients.
Retention Rate
Time frame: From baseline up to 4 months.
Registration of the participants attendance in the High-Intensity Functional Training compared with the number of possible training sessions during the period.
11 secondary outcomes
Assessment of changes in body weight
Time frame: Change from Baseline Body Weight at 2 months.
Assessment of changes in fat percentage
Time frame: Change from Baseline Fat Percentage at 2 months.
Assessment of changes in bone mass
Time frame: Change from Baseline Bone Mass at 2 months.
Assessment of changes in muscle mass
Time frame: Change from Baseline Muscle Mass at 2 months.
Assessment of changes in Visceral Fat
Time frame: Change from Baseline Visceral Fat at 2 months.
Assessment of changes in Resting Blood Pressure
Time frame: Change form Baseline Resting Blood Pressure at 2 months.
Assessment of changes in countermovement jump height
Time frame: Change form Baseline Jump Height at 2 months.
Assessment of changes in Leg Muscle Strength
Time frame: Change form Baseline Leg Muscle Strength at 2 months.
Assessment of changes in Hand Grip Strength
Time frame: Change form Baseline Hand Grip Strength at 2 months.
Assessment of changes in Balance
Time frame: Change form Baseline balance at 2 months.
Assessment of changes in Self-reported Physical Activity Behavior
Time frame: Change from Baseline Physical Activity Behaviour at 2 months.
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 14 Sep 2018.
- Derived from this study: PubMed 34412705Midtgaard J, Schnor H, Bjerre ED, Jespersen T, Jelsoe N, Frolund N, Seier S, Ronbog JW, Nordsborg NB, Ebdrup BH. Exercise training complementary to specialised early intervention in patients with first-episode psychosis: a feasibility randomised trial. Pilot Feasibility Stud. 2021 Aug 19;7(1):162. doi: 10.1186/s40814-021-00900-5.
- Derived from this study: PubMed 31226959Larsen LQ, Schnor H, Tersbol BP, Ebdrup BH, Nordsborg NB, Midtgaard J. The impact of exercise training complementary to early intervention in patients with first-episode psychosis: a qualitative sub-study from a randomized controlled feasibility trial. BMC Psychiatry. 2019 Jun 21;19(1):192. doi: 10.1186/s12888-019-2179-3.
- Official institutional websiteLink provided by the sponsor.
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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.
Julie Midtgaard, Ph.D. principal investigator
The University Hospitals Centre for Health Research (UCSF) / Copenhagen University Hospital (Rigshospitalet)
Helle Schnor, Ph.D. study director
Mental health services in the Capital Region of Denmark, Psychiatric Center Glostrup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The COPUS intervention in people with Schizophrenia and Schizotypal Disorder, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 inclusion and 4 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 14 Sep 2018. 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 Denmark. 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?
Assessment of changes in Physical Fitness (VO2max) (time frame: Change from Baseline Physical Fitness (VO2max) at 2 months.). 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 NCT03409393, which also lists 2 linked publications.
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 14 Sep 2018.