Mind and Body Approaches to Pain Reduction in Youth With Migraine

Prior treatment

• Must agree not to take non-specific acute medication, such as nonsteroidal anti-inflammatory drugs (NSAIDS) (e.g., ibuprofen), more than 3 times per week, or migraine specific acute medications, such as triptans, more than 6 times per month
• No current prophylactic anti-migraine medication within a period equivalent to \< 5 half-lives of that medication before entering the screening phase, and agree to not begin a migraine prevention medication during the study period
• Current use of the following medications/products: opioids, antipsychotics, antimanics, barbiturates, benzodiazepines, muscle relaxants, sedatives, tramadol, nutraceuticals
• Orthodontic braces, metallic or electronic implants, or other metal objects in the body which obscure or interfere with the MRI, or pose a risk from heating, movement, or malfunction in the MRI environment

Other illness

• Known history of allergic reaction or anaphylaxis to amitriptyline
• Diagnosis of epilepsy or other neurological diseases
• Present psychiatric disease as defined by the Diagnostic and Statistical Manual (DSM) IV (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, attention deficit hyperactivity disorder (ADHD), or mental retardation) that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study

Lab values

• Abnormal findings on electrocardiogram (ECG) at baseline, particularly lengthening of the QT interval ≥ 450 msec

Other

• Continuous migraine defined as an unrelenting headache for a 28 day period
• Weight less than 30 kg or greater than 120 kg, or weight/size incompatible with magnetic resonance imaging (MRI) scanner
• Claustrophobia
• Youth who are pregnant, or those who are sexually active and not using a medically accepted form of contraception (barrier or hormonal methods)
• Inability to learn how to swallow pills using behavioral techniques (if indicated)

• Diagnosis: Migraine with or without aura or chronic migraine that meets the International Classification of Headache Disorders, 3rd Edition (beta) (ICHD-3b) criteria
• Frequency: Headache frequency based upon prospective headache diary of 28 days must be ≥ 8 and ≤ 28
• PedMIDAS: PedMIDAS Disability Score \> 10, indicating at least mild disruption in daily activities and \< 140, indicating extreme disability that may require more comprehensive, multi-component therapy
• English speaking: able to complete interviews and questionnaires in English