ADHDPhase 4NCT01940978
A Study of Combination Therapy in Children With ADHD
A Phase 4 study testing Methylphenidate ER and Cyproheptadine in people with ADHD and Attention Deficit Hyperactivity Disorder, run by Douglas Sears at 1 site in United States.
Trial summary
Lack of appetite and weight loss are a common side effect of ADHD therapy with amphetamines such as methylphenidate. Lack of sufficient food intake has been shown to have negative effects on weight and height as well as learning and memory. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- ADHD, Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Methylphenidate ER and Cyproheptadine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2015
- Phase
- Phase 4
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The subject and subject's parents speak English
- Child or adolescent patients, male or female outpatients, who are at least 6 years of age, but must not yet have reached their 13th birthday prior to Visit 1, when informed consent is obtained
- Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV ADHD Subscale) score at both Visit 1 and 2
- Laboratory results, including serum chemistries, hematology, and urinalysis, must show no clinically significant abnormalities (clinically significant is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator)
- Patients and parents have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture, and examinations required by the protocol.
- Patient has not been on stimulants for at least 2 weeks.
Who cannot join
- Patients who have a documented history of Bipolar I or II disorder, or any history of psychosis. Diabetic patients or patients on chronic steroids.
- Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control are not eligible to participate
- Patients at serious suicidal risk as defined by 1) suicidal ideation as endorsed on items 4 and 5 of the C-SSRS within the past year, 2) suicidal behaviors detected by the C-SSRS during the past two years; or 3) psychiatric interview and examination
- Patients with significant cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure
- Patients who have any medical condition that would increase sympathetic nervous system activity markedly (for example, catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (for example, albuterol, inhalation aerosols, pseudoephedrine), that has sympathomimetic activity. Such medications can be taken on an as-needed basis
- Presence of contraindications for methylphenidate or cyproheptadine hydrochloride
- Patients who have had prior serious adverse reaction to stimulants.
- Parental or (immediate) family history of substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
SMRI (Schuster Medical Research Institute)
Van Nuys, California, 91403
About this study
Official title: A Double-Blind Placebo-Controlled Study of Combination Therapy in Children With ADHD
Lack of appetite and weight loss are a common side effect of ADHD therapy with amphetamines such as methylphenidate. Lack of sufficient food intake has been shown to have negative effects on weight and height as well as learning and memory.
There is no current treatment to prevent this loss of appetite except discontinuation or reduction of the methylphenidate. Discontinuation or reduction of the drug can cause the return of ADHD symptoms.
The purpose of this study is to compare the effects, good and/or bad, of two doses of a drug, cyproheptadine, vs placebo to find out if cyproheptadine prevents the appetite suppression associated with methylphenidate.
- Conditions
- ADHD, Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder With Hyperactivity, Mental Disorders Diagnosed in Childhood, Attention Deficit and Disruptive Behavior Disorders
- Being tested
- Methylphenidate ER, Cyproheptadine
- Keywords
- Methamphetamine, Methylphenidate, ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders, Attention Deficit and Disruptive Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylphenidate ERDrug
Also called Concerta
Watson generic, starting dose 18mg QD
CyproheptadineDrug
Also called Periactin
cyproheptadine hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Methylphenidate ER QD placebo BID Receives: Drug: Methylphenidate ER |
| Methylphenidate ER, cyproheptadine 2.5mg | Active comparator | Methylphenidate ER QD cyproheptadine hydrochloride 2.5mg BID Receives: Drug: Methylphenidate ER; Drug: Cyproheptadine |
| Methylphenidate ER, cyproheptadine 5mg | Active comparator | Methylphenidate ER QD cyproheptadine hydrochloride 5.0mg BID Receives: Drug: Methylphenidate ER; Drug: Cyproheptadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996)
Measured: 0, 12 weeks
Secondary outcomes (7)
Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score
The items from the DSM-IV (1994) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD) are included for the two subsets of symptoms: inattention (items #1-#9) and hyperactivity/ impulsivity (items #11-#19).
Measured: 0,1,5,9,12 weeks
Weight
Measured: 0,1,5,9,12 Weeks
Appetite - VAS - Visual Analogue Scale
Measured: 0,1,5,9,12
Clinical Global Impressions - Improvement(CGI-I): ADHD Score
Measured: 1,5,9,12 weeks
Clinical Global Impressions - Severity(CGI-S): ADHD Score
Measured: 0,1,5,9,12
Clinical Global Impressions - Effectiveness(CGI-E): ADHD Score
Measured: 1,5,9,12
Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996)
Measured: 1,5,9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Douglas Sears
- Responsible party
- Sponsor-investigator, Douglas Sears, Sears, Douglas, M.D.
- Investigators
- Jose M Schuster, MD, Principal investigator, SMRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940978
- Sponsor's protocol ID
- 001
- Status last verified
- Apr 2015
- First submitted
- 9 Sep 2013
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo-Controlled Study of Combination Therapy in Children With ADHD
- ClinicalTrials.gov ID
- NCT01940978
- Acronym / sponsor ID
- 001
- Conditions
- ADHD, Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder With Hyperactivity, Mental Disorders Diagnosed in Childhood, Attention Deficit and Disruptive Behavior Disorders
- Keywords
- Methamphetamine, Methylphenidate, ADHD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Douglas Sears
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 12 Sep 2013 (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.
Lack of appetite and weight loss are a common side effect of ADHD therapy with amphetamines such as methylphenidate. Lack of sufficient food intake has been shown to have negative effects on weight and height as well as learning and memory.
There is no current treatment to prevent this loss of appetite except discontinuation or reduction of the methylphenidate. Discontinuation or reduction of the drug can cause the return of ADHD symptoms.
The purpose of this study is to compare the effects, good and/or bad, of two doses of a drug, cyproheptadine, vs placebo to find out if cyproheptadine prevents the appetite suppression associated with methylphenidate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Methylphenidate ERMethylphenidate ER QD placebo BID |
| Methylphenidate ER, cyproheptadine 2.5mg | Active comparator | Drug: Methylphenidate ER, Drug: CyproheptadineMethylphenidate ER QD cyproheptadine hydrochloride 2.5mg BID |
| Methylphenidate ER, cyproheptadine 5mg | Active comparator | Drug: Methylphenidate ER, Drug: CyproheptadineMethylphenidate ER QD cyproheptadine hydrochloride 5.0mg BID |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The subject and subject's parents speak English
- Child or adolescent patients, male or female outpatients, who are at least 6 years of age, but must not yet have reached their 13th birthday prior to Visit 1, when informed consent is obtained
- Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV ADHD Subscale) score at both Visit 1 and 2
- Laboratory results, including serum chemistries, hematology, and urinalysis, must show no clinically significant abnormalities (clinically significant is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator)
- Patients and parents have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture, and examinations required by the protocol.
Key exclusion criteria (8 listed)
- Patients who have a documented history of Bipolar I or II disorder, or any history of psychosis. Diabetic patients or patients on chronic steroids.
- Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control are not eligible to participate
- Patients at serious suicidal risk as defined by 1) suicidal ideation as endorsed on items 4 and 5 of the C-SSRS within the past year, 2) suicidal behaviors detected by the C-SSRS during the past two years; or 3) psychiatric interview and examination
- Patients with significant cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure
- Patients who have any medical condition that would increase sympathetic nervous system activity markedly (for example, catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (for example, albuterol, inhalation aerosols, pseudoephedrine), that has sympathomimetic activity. Such medications can be taken on an as-needed basis
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 |
|---|---|---|
| Methylphenidate ERAlso: ConcertaWatson generic, starting dose 18mg QD | Drug | Control, Methylphenidate ER, cyproheptadine 2.5mg, Methylphenidate ER, cyproheptadine 5mg |
| CyproheptadineAlso: Periactincyproheptadine hydrochloride | Drug | Methylphenidate ER, cyproheptadine 2.5mg, Methylphenidate ER, cyproheptadine 5mg |
Primary outcome
Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996)
Time frame: 0, 12 weeks
7 secondary outcomes
Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score
Time frame: 0,1,5,9,12 weeks
Weight
Time frame: 0,1,5,9,12 Weeks
Appetite - VAS - Visual Analogue Scale
Time frame: 0,1,5,9,12
Clinical Global Impressions - Improvement(CGI-I): ADHD Score
Time frame: 1,5,9,12 weeks
Clinical Global Impressions - Severity(CGI-S): ADHD Score
Time frame: 0,1,5,9,12
Clinical Global Impressions - Effectiveness(CGI-E): ADHD Score
Time frame: 1,5,9,12
Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996)
Time frame: 1,5,9 weeks
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 10 Apr 2015.
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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.
Jose M Schuster, MD principal investigator
SMRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate ER and Cyproheptadine in people with ADHD and Attention Deficit Hyperactivity Disorder, run by Douglas Sears at 1 site in United States.
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 6 inclusion and 8 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 10 Apr 2015. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996) (time frame: 0, 12 weeks). 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 Apr 2015.