NCT00389038

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2006

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 25, 2011

Status Verified

April 1, 2011

Enrollment Period

5.8 years

First QC Date

October 16, 2006

Last Update Submit

April 21, 2011

Conditions

Headache

Keywords

headachecoping skills trainingamitriptylineattention control

Outcome Measures

Primary Outcomes (1)

  • Headache diaries assess headache frequency.

    Completed one month prior to first visit, then weekly up to Week 20, then one month prior to Month 3, 6, 9, and 12 Follow-Up Visits.

Secondary Outcomes (3)

  • The Child Depression Inventory.

    Completed at Baseline, Week 20, and Months 3, 6, 9, and 12.

  • The PedsQL measures the impact of chronic illness and quality of life.

    Completed at Baseline, Week 20, and Months 3, 6, 9, and 12.

  • Pediatric Migraine Disability Assessment (PedMIDAS) evaluates the impact of headaches on life activities.

    Completed at Baseline, Week 20, and Months 3, 6, 9, and 12.

Study Arms (2)

Coping Skills Training + Amitriptyline

ACTIVE COMPARATOR

Behavioral coping skills training--Behavioral Treatment session 1 and 2: Doses are one session a week for 8 weeks, followed by one session a month for 2 months, followed by 1 session every three months for 1 year.

Behavioral: Coping Skills TrainingDrug: Amitriptyline

Headache Education + Amitriptyline

ACTIVE COMPARATOR

Behavioral headache education

Behavioral: Headache EducationDrug: Amitriptyline

Interventions

Coping Skills TrainingBEHAVIORAL

Behavioral Treatment 1 (coping skills training)--Behavioral Treatment session 1 and 2: Doses are one session a week for 8 weeks, followed by one session a month for 2 months, followed by 1 session every three months for 1 year.

Coping Skills Training + Amitriptyline
Headache EducationBEHAVIORAL

Behavioral Treatment 2 (headache education)

Headache Education + Amitriptyline
AmitriptylineDRUG

Amitriptyline: up to 1 mg/kg capsule taken once daily at bedtime. Taken up to Week 20. After Week 20 medications and doses may change with standard care.

Coping Skills Training + AmitriptylineHeadache Education + Amitriptyline

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Mail Location 3015

Cincinnati, Ohio, 45229-3039, United States

Location

Related Publications (5)

  • Rettig EK, Ergun G, Warfield JR, Slater SK, LeCates SL, Kabbouche MA, Kacperski J, Hershey AD, Powers SW. Predictors of Improvement in Pediatric Chronic Migraine: Results from the Cognitive-Behavioral Therapy and Amitriptyline Trial. J Clin Psychol Med Settings. 2022 Mar;29(1):113-119. doi: 10.1007/s10880-021-09782-4. Epub 2021 May 24.

    PMID: 34028656DERIVED

  • Kroner JW, Peugh J, Kashikar-Zuck SM, LeCates SL, Allen JR, Slater SK, Zafar M, Kabbouche MA, O'Brien HL, Shenk CE, Kroon Van Diest AM, Hershey AD, Powers SW. Trajectory of Improvement in Children and Adolescents With Chronic Migraine: Results From the Cognitive-Behavioral Therapy and Amitriptyline Trial. J Pain. 2017 Jun;18(6):637-644. doi: 10.1016/j.jpain.2017.01.002. Epub 2017 Jan 18.

    PMID: 28108386DERIVED

  • Kroner JW, Hershey AD, Kashikar-Zuck SM, LeCates SL, Allen JR, Slater SK, Zafar M, Kabbouche MA, O'Brien HL, Shenk CE, Rausch JR, Kroon Van Diest AM, Powers SW. Cognitive Behavioral Therapy plus Amitriptyline for Children and Adolescents with Chronic Migraine Reduces Headache Days to </=4 Per Month. Headache. 2016 Apr;56(4):711-6. doi: 10.1111/head.12795. Epub 2016 Mar 18.

    PMID: 26992129DERIVED

  • Powers SW, Kashikar-Zuck SM, Allen JR, LeCates SL, Slater SK, Zafar M, Kabbouche MA, O'Brien HL, Shenk CE, Rausch JR, Hershey AD. Cognitive behavioral therapy plus amitriptyline for chronic migraine in children and adolescents: a randomized clinical trial. JAMA. 2013 Dec 25;310(24):2622-30. doi: 10.1001/jama.2013.282533.

    PMID: 24368463DERIVED

  • Zafar M, Kashikar-Zuck SM, Slater SK, Allen JR, Barnett KA, Lecates SL, Kabbouche MA, Hershey AD, Powers SW. Childhood abuse in pediatric patients with chronic daily headache. Clin Pediatr (Phila). 2012 Jun;51(6):590-3. doi: 10.1177/0009922811407181. Epub 2011 May 18. No abstract available.

    PMID: 21593054DERIVED

Related Links

MeSH Terms

Conditions

Headache

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Scott W. Powers, PhD, ABPP, FAHS

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 16, 2006

First Posted

October 17, 2006

Study Start

October 1, 2006

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

April 25, 2011

Record last verified: 2011-04

Locations

US(1)