A Study of Combination Therapy in Children With ADHD
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01940978 |
Recruitment Status :
Completed
First Posted : September 12, 2013
Last Update Posted : April 10, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
ADHD Attention Deficit Hyperactivity Disorder Attention Deficit Disorder With Hyperactivity Mental Disorders Diagnosed in Childhood Attention Deficit and Disruptive Behavior Disorders | Drug: Methylphenidate ER Drug: Cyproheptadine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 99 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Double-Blind Placebo-Controlled Study of Combination Therapy in Children With ADHD |
Study Start Date : | March 2014 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | March 2015 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Control
Methylphenidate ER QD placebo BID
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Drug: Methylphenidate ER
Watson generic, starting dose 18mg QD
Other Name: Concerta |
Active Comparator: Methylphenidate ER, cyproheptadine 2.5mg
Methylphenidate ER QD cyproheptadine hydrochloride 2.5mg BID
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Drug: Methylphenidate ER
Watson generic, starting dose 18mg QD
Other Name: Concerta Drug: Cyproheptadine cyproheptadine hydrochloride
Other Name: Periactin |
Active Comparator: Methylphenidate ER, cyproheptadine 5mg
Methylphenidate ER QD cyproheptadine hydrochloride 5.0mg BID
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Drug: Methylphenidate ER
Watson generic, starting dose 18mg QD
Other Name: Concerta Drug: Cyproheptadine cyproheptadine hydrochloride
Other Name: Periactin |
- Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996) [ Time Frame: 0, 12 weeks ]
- Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score [ Time Frame: 0,1,5,9,12 weeks ]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).
- 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 ]

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Ages Eligible for Study: | 6 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940978
United States, California | |
SMRI (Schuster Medical Research Institute) | |
Van Nuys, California, United States, 91403 |
Principal Investigator: | Jose M Schuster, MD | SMRI |
Responsible Party: | Douglas Sears, Douglas Sears, MD, Sears, Douglas, M.D. |
ClinicalTrials.gov Identifier: | NCT01940978 |
Other Study ID Numbers: |
001 |
First Posted: | September 12, 2013 Key Record Dates |
Last Update Posted: | April 10, 2015 |
Last Verified: | April 2015 |
Methamphetamine Methylphenidate ADHD |
Hyperkinesis Disease Attention Deficit Disorder with Hyperactivity Mental Disorders Problem Behavior Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Pathologic Processes Dyskinesias Neurologic Manifestations Nervous System Diseases Behavioral Symptoms Cyproheptadine Methylphenidate Central Nervous System Stimulants |
Physiological Effects of Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Antipruritics Dermatologic Agents Gastrointestinal Agents Histamine H1 Antagonists Histamine Antagonists Histamine Agents Serotonin Antagonists Serotonin Agents |