Objective: There has been an increasing focus on the ethical issues raised
by studies requiring the withdrawal of effective medication in schizophreni
c adults. This article examines the risks and benefits of a medication-free
period for pediatric patients with treatment-refractory schizophrenia who
are participating in an ongoing study. Method: Between April 1993 and March
1998, 31 children and adolescents were admitted with a diagnosis of treatm
ent-resistant, childhood-onset schizophrenia. Parental consent was obtained
so that patients could participate in a medication-free research period. P
atients were evaluated at screening, at the end of a 4-week washout, at the
completion of a 6- to 8-week atypical neuroleptic trial, and at a 2- to 4-
year follow-up. Results: At the completion of a 4-week drug-free period, se
ven patients (23%) were diagnosed with another disorder on the basis of dat
a gained from the drug-free period and their lack of schizophrenic symptoms
. Their revised diagnoses were posttraumatic stress disorder (N=1), an atyp
ical psychosis labeled "multidimensionally impaired" (N=4), and personality
disorder (N=2). At follow-up, three of these patients remained free of neu
roleptic therapy, For eight patients (26%), the washout was curtailed becau
se of rapid and severe deterioration of their schizophrenic symptoms. Concl
usions: For children and adolescents with treatment-refractory schizophreni
a, a medication-free period can be conducted safely for at least 4 weeks fo
r inpatients. Such trials are useful on clinical grounds and for providing
homogeneous patient groups for research. This study also highlights the nec
essity of having access to hospitalization to observe children and adolesce
nts with psychotic symptoms while medication free.