A Study of Combination Therapy in Children With ADHD

• Sponsor: Douglas Sears (Other)
• Overall Status: Completed
• CT.gov ID: NCT01940978
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief 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.

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 Design

• Study Type: Interventional
• 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: Mar 1, 2014
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Methylphenidate ER QD placebo BID	Drug: Methylphenidate ER; Watson generic, starting dose 18mg QD; Other Names: 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 Names: Concerta ; Drug: Cyproheptadine; cyproheptadine hydrochloride; Other Names: 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 Names: Concerta ; Drug: Cyproheptadine; cyproheptadine hydrochloride; Other Names: Periactin

Outcome Measures

Primary Outcome Measures

1. Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996) [0, 12 weeks]

Secondary Outcome Measures

1. Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score [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).

2. Weight [0,1,5,9,12 Weeks]

3. Appetite - VAS - Visual Analogue Scale [0,1,5,9,12]

4. Clinical Global Impressions - Improvement(CGI-I): ADHD Score [1,5,9,12 weeks]

5. Clinical Global Impressions - Severity(CGI-S): ADHD Score [0,1,5,9,12]

6. Clinical Global Impressions - Effectiveness(CGI-E): ADHD Score [1,5,9,12]

7. Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996) [1,5,9 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SMRI (Schuster Medical Research Institute)	Van Nuys	California	United States	91403

Sponsors and Collaborators

• Douglas Sears

Investigators

• Principal Investigator: Jose M Schuster, MD, SMRI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Douglas Sears, Douglas Sears, MD, Sears, Douglas, M.D.
• ClinicalTrials.gov Identifier: NCT01940978
• Other Study ID Numbers: 001
• First Posted: Sep 12, 2013
• Last Update Posted: Apr 10, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Douglas Sears, Douglas Sears, MD, Sears, Douglas, M.D.: Methamphetamine; Methylphenidate; ADHD
• Additional relevant MeSH terms: Hyperkinesis; Disease; Attention Deficit Disorder with Hyperactivity; Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Cyproheptadine; Methylphenidate

Study Results

No Results Posted as of Apr 10, 2015