A Study of Combination Therapy in Children With ADHD

• ClinicalTrials.gov Identifier: NCT01940978
• Recruitment Status: Completed
• First Posted: September 12, 2013
• Last Update Posted: April 10, 2015
• Sponsor: Douglas Sears
• Information provided by (Responsible Party): Douglas Sears, Sears, Douglas, M.D.

Tracking Information

• First Submitted Date: September 9, 2013
• First Posted Date: September 12, 2013
• Last Update Posted Date: April 10, 2015
• Study Start Date: March 2014
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 11, 2013): Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996) [ Time Frame: 0, 12 weeks ]

Original Primary Outcome Measures (submitted: September 9, 2013)

Appetite - ADAT [ Time Frame: 12 weeks ]

Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996).

Current Secondary Outcome Measures (submitted: July 2, 2014)

• 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 ]

Original Secondary Outcome Measures (submitted: September 9, 2013)

• Appetite - ADAT [ Time Frame: 0,1,4,8 weeks ]
  Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996).
• DSM-IV ADHD symptom checklist (SNAP-IV) [ Time Frame: 0,1,4,8,12 weeks ]
  The SNAP-IV Rating Scale is a revision of the Swanson, Nolan and Pelham (SNAP) Questionnaire (Swanson et al, 1983). 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: 0,1,4,8,12 Weeks ]
• Appetite - VAS [ Time Frame: 0,1,4,8,12 ]
  VAS - Visual Analogue Scale
• CGI-I [ Time Frame: 1,4,8,12 weeks ]
  Clinical Global Impression - Improvement scale (CGI-I)
• CGI-S [ Time Frame: 0,1,4,8,12 ]
  Clinical Global Impression - Severity Scale (CGI-S)
• CGI-E [ Time Frame: 1,4,8,12 ]
  Clinical Global Impression - Effectiveness Scale (CGI-E)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Combination Therapy in Children With ADHD
• Official Title: A Double-Blind Placebo-Controlled Study of Combination Therapy in Children With ADHD

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• ADHD
• Attention Deficit Hyperactivity Disorder
• Attention Deficit Disorder With Hyperactivity
• Mental Disorders Diagnosed in Childhood
• Attention Deficit and Disruptive Behavior Disorders

Intervention

• Drug: Methylphenidate ER
  Watson generic, starting dose 18mg QD
  Other Name: Concerta
• Drug: Cyproheptadine
  cyproheptadine hydrochloride
  Other Name: Periactin

Study Arms

• Placebo Comparator: Control
  Methylphenidate ER QD placebo BID
  Intervention: Drug: Methylphenidate ER
• Active Comparator: Methylphenidate ER, cyproheptadine 2.5mg
  Methylphenidate ER QD cyproheptadine hydrochloride 2.5mg BID
  Interventions:

  • Drug: Methylphenidate ER
  • Drug: Cyproheptadine
• Active Comparator: Methylphenidate ER, cyproheptadine 5mg
  Methylphenidate ER QD cyproheptadine hydrochloride 5.0mg BID
  Interventions:

  • Drug: Methylphenidate ER
  • Drug: Cyproheptadine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 9, 2013): 99
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2015
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01940978
• Other Study ID Numbers: 001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Douglas Sears, Sears, Douglas, M.D.
• Original Responsible Party: Same as current
• Current Study Sponsor: Douglas Sears
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jose M Schuster, MD; SMRI

• PRS Account: Sears, Douglas, M.D.
• Verification Date: April 2015