A placebo-controlled crossover trial using trazodone in pediatric migraine
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P A Battistella1, R Ruffilli, R Cernetti
1Department of Pediatrics, University of Padua, Italy.
Insights
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.
Abstract:
An 8-month, double-blind, placebo-controlled cross-over trial was carried out on the use of trazodone in pediatric migraine prophylaxis. It involved 40 patients aged 7 to 18 years old and suffering from migraine without aura, randomly divided into 2 groups. After a 4-week run-in period, Group A received oral trazodone (1 mg/kg a day divided into 3 doses) for 12 weeks, while Group B received a placebo. After a further 4-week washout period, Group A was given the placebo and Group B was treated with trazodone for a further 12 weeks. The trial was completed by 35 patients, the number of drop-outs being comparable in the two groups. During the first treatment period, both the frequency and the duration of the migraine episodes were significantly reduced in both groups. During the second, a significant further improvement in both parameters was only observed in Group B. No side-effects were observed at any time. Our results showed that, like other antidepressants, trazodone is a valid prophylactic agent for juvenile migraine.