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A placebo-controlled crossover trial using trazodone in pediatric migraine
P A Battistella1, R Ruffilli, R Cernetti
1Department of Pediatrics, University of Padua, Italy.
Headache
|January 1, 1993
Summary
Trazodone effectively reduced migraine frequency and duration in children and adolescents. This study indicates trazodone is a safe and valid prophylactic treatment for juvenile migraine.
Area of Science:
- Neurology
- Pediatrics
- Pharmacology
Background:
- Migraine is a common neurological disorder in children and adolescents.
- Effective prophylactic treatments for pediatric migraine are limited.
- Trazodone, an antidepressant, has shown potential in migraine prophylaxis.
Purpose of the Study:
- To evaluate the efficacy and safety of trazodone for pediatric migraine prophylaxis.
- To compare trazodone's effect against a placebo in a crossover trial design.
Main Methods:
- An 8-month, double-blind, placebo-controlled crossover trial involving 40 patients (7-18 years old) with migraine without aura.
- Patients received either oral trazodone (1 mg/kg/day) or placebo for 12 weeks, followed by a 4-week washout and then switched treatments.
- Outcomes measured included migraine frequency and duration.
Main Results:
- Both trazodone and placebo groups showed significant reductions in migraine frequency and duration during their respective treatment periods.
- A significant further improvement in both parameters was observed only in the group treated with trazodone during the second treatment period.
- No adverse side effects were reported throughout the study.
Conclusions:
- Trazodone is a safe and effective prophylactic agent for juvenile migraine.
- The findings support the use of trazodone as a treatment option for migraine in pediatric populations.
- Further research may explore optimal dosing and long-term efficacy.