Pediatric Chronic Headache Trial
Pediatric Chronic Headache Trial
The purpose of this trial is to evaluate the efficacy of combined behavioral and
 pharmacological treatment on chronic daily headache in children ages 10 to 17.
Chronic daily headache (CDH)--defined as having headaches 15 or more days per month--is a
 frequent and debilitating condition in children that results in severe decreased quality of
 life and emotional stress. Very little is known about the most effective types of treatment
 for CDH in children and adolescents. Development of effective interventions for youth with
 CDH could potentially prevent the progression of a very painful and costly condition into
 adulthood. Treatments combining pharmacological (drug) interventions with behavior change
 have been found effective in treating adults with chronic pain, including headaches, but have
 been understudied in children.

 The goal of this randomized, controlled clinical trial is to determine the efficacy of
 combined behavioral and drug treatment of CDH in youth ages 10 to 17. In the study,
 scientists will investigate if a combination of pain coping skills training (CST) and the
 drug amitriptyline (AMI)--CST-AMI--is effective in reducing headache frequency, functional
 disability, and symptoms of depression. More specifically, the researchers will evaluate if
 CST-AMI is superior to AMI combined with an attention control (ATT). The CST will mainly
 focus on learning skills for coping with pain, and the ATT will focus on understanding
 chronic headaches and lifestyle information.

 Participants will be randomly assigned to one of the two treatment groups: CST-AMI or
 ATT-AMI. Those assigned to CST-AMI will complete 8 weekly sessions of coping training and 2
 monthly maintenance-promoting sessions. Sessions will focus on teaching biofeedback, muscle
 relaxation techniques, imagery, distraction, activity pacing, problem solving, and calming
 techniques, using a treatment manual developed and tested in youth with CDH. Those assigned
 to ATT-AMI will receive the same amount of therapist support and attention but not the active
 behavioral training. All participants will receive the study medication, AMI.

 Headache frequency, functional disability, pain and headache characteristics, quality of
 life, and symptoms of depression will be assessed before and after treatment, and reassessed
 at 3, 6, 9, and 12 months. For participants, duration of the study--which includes treatment
 and follow-up phases--lasts about 18 months. The treatment phase includes 12 study visits and
 the follow-up phase includes 4 study visits.

 The long-term objective of this research is to establish effective treatments for CDH in
 youth that lead to significantly reduced headache frequency and functional disability.
Inclusion Criteria:

 -  diagnosis of chronic daily headache based on definition of 15 or more headache days
 per month measured by a prospective daily headache diary

 -  females or males between the ages of 10-17

 -  PedMIDAS Disability Score > 20, indicating at least moderate disruption in daily
 activities

 Exclusion Criteria:

 -  medication overuse as defined in the ICHD-II criteria (NSAID or other simple analgesic
 on ≥ 15 days/ month for >3 months; triptan intake in any formulation ≥ 10 days/month
 on a regular basis of ≥ 3 months)

 -  current treatment with amitriptyline

 -  no other current prophylactic antimigraine medication within a period equivalent to <
 5 half-lives of that medication before entering the screening phase

 -  other chronic pain condition such as juvenile primary fibromyalgia syndrome, complex
 regional pain syndrome-II

 -  abnormal findings on EKG

 -  current or past history of severe orthostatic intolerance or severe levels of
 orthostatic dysregulation (orthostatic hypotension or postural orthostatic tachycardia
 syndrome)

 -  significant documented developmental delay or impairments such as autism, cerebral
 palsy or mental retardation

 -  present or lifetime psychiatric diagnosis that meets DSM-IV criteria for bipolar
 disorder, major depressive disorder or psychosis

 -  PedMIDAS Disability Score of > 140, indicating need for multi-systemic therapies to
 address very significant level of disability

 -  youth who are pregnant, or those females who are sexually active and not using a
 medically accepted form of contraception (barrier or hormonal methods) or do not agree
 to be abstinent during the study

 -  disallowed medications/products: opioids, antipsychotics, antimanics, barbiturates,
 benzodiazepines, muscle relaxants, sedatives, tramadol