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A Study of Combination Therapy in Children With ADHD

This study has been completed.
Information provided by (Responsible Party):
Douglas Sears, Sears, Douglas, M.D. Identifier:
First received: September 9, 2013
Last updated: April 8, 2015
Last verified: April 2015

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 Intervention Phase
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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Study of Combination Therapy in Children With ADHD

Resource links provided by NLM:

Further study details as provided by Sears, Douglas, M.D.:

Primary Outcome Measures:
  • Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996) [ Time Frame: 0, 12 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 99
Study Start Date: March 2014
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Methylphenidate ER QD placebo BID
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
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
Drug: Methylphenidate ER
Watson generic, starting dose 18mg QD
Other Name: Concerta
Drug: Cyproheptadine
cyproheptadine hydrochloride
Other Name: Periactin


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
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Please refer to this study by its identifier: NCT01940978

United States, California
SMRI (Schuster Medical Research Institute)
Van Nuys, California, United States, 91403
Sponsors and Collaborators
Douglas Sears
Principal Investigator: Jose M Schuster, MD SMRI
  More Information

Responsible Party: Douglas Sears, Douglas Sears, MD, Sears, Douglas, M.D. Identifier: NCT01940978     History of Changes
Other Study ID Numbers: 001
Study First Received: September 9, 2013
Last Updated: April 8, 2015

Keywords provided by Sears, Douglas, M.D.:

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Psychotic Disorders
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Behavioral Symptoms
Dermatologic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin Antagonists
Serotonin Agents
Anti-Allergic Agents
Central Nervous System Stimulants processed this record on May 22, 2017