A Study of Combination Therapy in Children With ADHD
| Status: | Recruiting |
|---|---|
| Conditions: | Cognitive Studies, Neurology, Psychiatric, Psychiatric, Psychiatric, ADHD |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 6 - 12 |
| Updated: | 2/7/2015 |
| Start Date: | March 2014 |
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.
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.
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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