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Tricyclic Antidepressant

Headache Education + Amitriptyline for Headache

Phase 3
Waitlist Available
Led By Scott W. Powers, PhD, ABPP, FAHS
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completed at baseline, week 20, and months 3, 6, 9, and 12.
Awards & highlights

Study 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.

Eligible Conditions
  • Headache

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completed at baseline, week 20, and months 3, 6, 9, and 12.
This trial's timeline: 3 weeks for screening, Varies for treatment, and completed at baseline, week 20, and months 3, 6, 9, and 12. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Headache diaries assess headache frequency.
Secondary outcome measures
Pediatric Migraine Disability Assessment (PedMIDAS) evaluates the impact of headaches on life activities.
The Child Depression Inventory.
The PedsQL measures the impact of chronic illness and quality of life.

Trial Design

2Treatment groups
Active Control
Group I: Headache Education + AmitriptylineActive Control2 Interventions
Behavioral headache education
Group II: Coping Skills Training + AmitriptylineActive Control2 Interventions
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.

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,229 Total Patients Enrolled
11 Trials studying Headache
2,241 Patients Enrolled for Headache
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,459 Total Patients Enrolled
5 Trials studying Headache
1,723 Patients Enrolled for Headache
Scott W. Powers, PhD, ABPP, FAHSPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pediatric Chronic Headache Trial
2006. "Pediatric Chronic Headache Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00389038.
All > Chronic Daily Headache
~7 spots leftby Apr 2025
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