Trial record 24 of 120 for:    ADHD | Open Studies | United States | Child, Adult

A Study of Combination Therapy in Children With ADHD

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sears, Douglas, M.D.
Sponsor:
Information provided by (Responsible Party):
Douglas Sears, Sears, Douglas, M.D.
ClinicalTrials.gov Identifier:
NCT01940978
First received: September 9, 2013
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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
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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score [ Time Frame: 0,1,5,9,12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Appetite - VAS - Visual Analogue Scale [ Time Frame: 0,1,5,9,12 ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Improvement(CGI-I): ADHD Score [ Time Frame: 1,5,9,12 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Severity(CGI-S): ADHD Score [ Time Frame: 0,1,5,9,12 ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Effectiveness(CGI-E): ADHD Score [ Time Frame: 1,5,9,12 ] [ Designated as safety issue: No ]
  • Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996) [ Time Frame: 1,5,9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 99
Study Start Date: March 2014
Estimated Primary Completion Date: December 2014 (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

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01940978

Locations
United States, California
SMRI (Schuster Medical Research Institute) Recruiting
Van Nuys, California, United States, 91403
Contact: Jose M Schuster, MD    818-788-0746    schuster@smrionline.com   
Principal Investigator: Jose M Schuster, MD         
Sponsors and Collaborators
Douglas Sears
Investigators
Principal Investigator: Jose M Schuster, MD SMRI
  More Information

No publications provided

Responsible Party: Douglas Sears, Douglas Sears, MD, Sears, Douglas, M.D.
ClinicalTrials.gov Identifier: NCT01940978     History of Changes
Other Study ID Numbers: 001
Study First Received: September 9, 2013
Last Updated: July 2, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by Sears, Douglas, M.D.:
Methamphetamine
Methylphenidate
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Psychotic Disorders
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Mental Disorders Diagnosed in Childhood
Schizophrenia and Disorders with Psychotic Features
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cyproheptadine
Methylphenidate
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014