MethylphenidateNCT02704546
Methylphenidate (Ritalin®) Effect During Exposure to Exercise and Heat Stress in ADD/ADHD Treated Patients
A study testing Methylphenidate in people with Methylphenidate, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to explore the possible effects of MPH use on physiological functions among ADHD\ADD patients, by performing a set of physical trials to assess aerobic and anaerobic capacity, to characterize the tendency for muscle break down while performing monitored moderate physical effort and to… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Methylphenidate
- What is being tested?
- Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to Sep 2017
- 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Civilian volunteers aged 18-25 years.
- BMI range of 17-25.
- Diagnosed with attention deficit disorder (ADD or ADHD) since childhood.
- Routine use of Methylphenidate (at least 5 days a week).
- Without known medical illness or medication use.
- Report of performing physical exercise (twice or more a week).
- Without history of heat injury.
Who cannot join
- The existence or suspicion of existing cardiac or respiratory disease.
- Infectious disease 3 days prior to the experiment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Drug Methylphenidate on Physiological Stress and Function During Exposure to Exercise and Heat Stress in ADD/ADHD Treated Patients
The purpose of this study is to explore the possible effects of MPH use on physiological functions among ADHD\ADD patients, by performing a set of physical trials to assess aerobic and anaerobic capacity, to characterize the tendency for muscle break down while performing monitored moderate physical effort and to assess the physiological strain while performing moderate exercise in heat load conditions by using the heat tolerance test.
Read the detailed description
20 male, non-combat soldiers with a pre-existing childhood diagnosis of ADHD\ADD, who are chronically treated with MPH will participate in the study. If necessary, civilian volunteers with a childhood diagnosis of ADHD\ADD may also be recruited to complete the study population (up to 50%, i.e. 10 participants).
- st encounter: the subjects will receive an explanation of the study and sign an informed consent form, complete a medical questionnaire and undergo physical examination by a physician, including ECG.
- nd-9th encounter: the subjects will be requested to undergo 10 tests on 8 examination days, which will include the: maximal oxygen consumption test, wingate test, heat tolerance test and step test. Each subject will perform each test twice: once while taking MPH and once with placebo.
- Conditions
- Methylphenidate
- Being tested
- Methylphenidate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Ritalin®, MPH
oral capsules (per os) each containing 10mg Methylphenidate.
PlaceboDrug
capsules identical in shape, colour and size to the Ritalin® capsules, which contain only the inactive ingredients of the same formulation.
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate | Experimental | In experimental days taking MPH, subjects will take 20mg Ritalin® (Novartis AG) in two tablets of 10mg, by swallow 1 hour prior to performing the physical test. Receives: Drug: Methylphenidate |
| Placebo | Placebo comparator | In experimental days with placebo subjects will be asked to ingest 2 capsules identical to Ritalin® capsules, by swallow 1 hour prior to performing the physical test. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
physiological strain (composite)
the physiological strain will be determined by monitoring body core temperature and heart rate of the subjects during a Heat Tolerant Test (HTT). the test is performed in a climatic chamber. during the test the subjects walks on a treadmill (5 km/h and 2% incline) for 2h.
Measured: 2 experimental days for each participant
aerobic capacity
the aerobic capacity of the subjects will be determined by performing a maximal oxygen consumption test (VO2max). VO2 will be monitored continuously with a metabolic system (ERGOTEST 680, ZAN, GERMANY ).
Measured: 2 experimental days for each participant
Secondary outcomes (4)
Rectal temperature
rectal temperature will be recorded at a depth of 10 mm past the anal sphincter using YSI-401 thermal thermistor during each heat tolerance test (HTT).
Measured: 2 experimental days for each participant
skin temperature
The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
Measured: 2 experimental days for each participant
heart rate
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
Measured: 8 experimental days for each participant
lactic acid
lactic acid level is assessed from blood drop (finger sting), will be taken before and after every test. lactic acid is a marker for anaerobic effort evaluating.
Measured: 8 experimental days for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MethylphenidateStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Haggai Schermann, M.D, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704546
- Sponsor's protocol ID
- SHEBA-14-1245-HS-CTIL
- Status last verified
- Mar 2016
- First submitted
- 6 Mar 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Drug Methylphenidate on Physiological Stress and Function During Exposure to Exercise and Heat Stress in ADD/ADHD Treated Patients
- ClinicalTrials.gov ID
- NCT02704546
- Acronym / sponsor ID
- SHEBA-14-1245-HS-CTIL
- Conditions
- Methylphenidate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 10 Mar 2016 (estimated)
- 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 purpose of this study is to explore the possible effects of MPH use on physiological functions among ADHD\ADD patients, by performing a set of physical trials to assess aerobic and anaerobic capacity, to characterize the tendency for muscle break down while performing monitored moderate physical effort and to assess the physiological strain while performing moderate exercise in heat load conditions by using the heat tolerance test.
Detailed description
20 male, non-combat soldiers with a pre-existing childhood diagnosis of ADHD\ADD, who are chronically treated with MPH will participate in the study. If necessary, civilian volunteers with a childhood diagnosis of ADHD\ADD may also be recruited to complete the study population (up to 50%, i.e. 10 participants).
- st encounter: the subjects will receive an explanation of the study and sign an informed consent form, complete a medical questionnaire and undergo physical examination by a physician, including ECG.
- nd-9th encounter: the subjects will be requested to undergo 10 tests on 8 examination days, which will include the: maximal oxygen consumption test, wingate test, heat tolerance test and step test. Each subject will perform each test twice: once while taking MPH and once with placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Experimental | Drug: MethylphenidateIn experimental days taking MPH, subjects will take 20mg Ritalin® (Novartis AG) in two tablets of 10mg, by swallow 1 hour prior to performing the physical test. |
| Placebo | Placebo comparator | Drug: PlaceboIn experimental days with placebo subjects will be asked to ingest 2 capsules identical to Ritalin® capsules, by swallow 1 hour prior to performing the physical test. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Civilian volunteers aged 18-25 years.
- BMI range of 17-25.
- Diagnosed with attention deficit disorder (ADD or ADHD) since childhood.
- Routine use of Methylphenidate (at least 5 days a week).
- Without known medical illness or medication use.
Key exclusion criteria (2 listed)
- The existence or suspicion of existing cardiac or respiratory disease.
- Infectious disease 3 days prior to the experiment.
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 |
|---|---|---|
| MethylphenidateAlso: Ritalin®, MPHoral capsules (per os) each containing 10mg Methylphenidate. | Drug | Methylphenidate |
| Placebocapsules identical in shape, colour and size to the Ritalin® capsules, which contain only the inactive ingredients of the same formulation. | Drug | Placebo |
Primary outcome
physiological strain (composite)
Time frame: 2 experimental days for each participant
the physiological strain will be determined by monitoring body core temperature and heart rate of the subjects during a Heat Tolerant Test (HTT). the test is performed in a climatic chamber. during the test the subjects walks on a treadmill (5 km/h and 2% incline) for 2h.
aerobic capacity
Time frame: 2 experimental days for each participant
the aerobic capacity of the subjects will be determined by performing a maximal oxygen consumption test (VO2max). VO2 will be monitored continuously with a metabolic system (ERGOTEST 680, ZAN, GERMANY ).
4 secondary outcomes
Rectal temperature
Time frame: 2 experimental days for each participant
skin temperature
Time frame: 2 experimental days for each participant
heart rate
Time frame: 8 experimental days for each participant
lactic acid
Time frame: 8 experimental days for each participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Individual participant dataSharing planned: No
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Written Exposure Therapy Plus Adjunctive Methylphenidate Treatment for Veterans With PTSD
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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.
Haggai Schermann, M.D principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylphenidate in people with Methylphenidate, run by Sheba Medical Center at 1 site in Israel.
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 7 inclusion and 2 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 10 Mar 2016. 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 Israel. 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?
Contact Haggai Schermann, M.D (+972828771014, Haggai.Schermann@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiological strain (composite) (time frame: 2 experimental days for each participant). The study lists 2 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 10 Mar 2016.