- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01940978
A Study of Combination Therapy in Children With ADHD
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
Van Nuys, California, United States, 91403
- SMRI (Schuster Medical Research Institute)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
Methylphenidate ER QD placebo BID
|
Watson generic, starting dose 18mg QD
Other Names:
|
Active Comparator: Methylphenidate ER, cyproheptadine 2.5mg
Methylphenidate ER QD cyproheptadine hydrochloride 2.5mg BID
|
Watson generic, starting dose 18mg QD
Other Names:
cyproheptadine hydrochloride
Other Names:
|
Active Comparator: Methylphenidate ER, cyproheptadine 5mg
Methylphenidate ER QD cyproheptadine hydrochloride 5.0mg BID
|
Watson generic, starting dose 18mg QD
Other Names:
cyproheptadine hydrochloride
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996)
Time Frame: 0, 12 weeks
|
0, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
0,1,5,9,12 weeks
|
Weight
Time Frame: 0,1,5,9,12 Weeks
|
0,1,5,9,12 Weeks
|
|
Appetite - VAS - Visual Analogue Scale
Time Frame: 0,1,5,9,12
|
0,1,5,9,12
|
|
Clinical Global Impressions - Improvement(CGI-I): ADHD Score
Time Frame: 1,5,9,12 weeks
|
1,5,9,12 weeks
|
|
Clinical Global Impressions - Severity(CGI-S): ADHD Score
Time Frame: 0,1,5,9,12
|
0,1,5,9,12
|
|
Clinical Global Impressions - Effectiveness(CGI-E): ADHD Score
Time Frame: 1,5,9,12
|
1,5,9,12
|
|
Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996)
Time Frame: 1,5,9 weeks
|
1,5,9 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jose M Schuster, MD, SMRI
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Disease
- Problem Behavior
- Mental Disorders
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Neurodevelopmental Disorders
- Attention Deficit and Disruptive Behavior Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Gastrointestinal Agents
- Dermatologic Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Uptake Inhibitors
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Central Nervous System Stimulants
- Methylphenidate
- Cyproheptadine
Other Study ID Numbers
- 001 (NavyGHB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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