Related Experiment Videos
Including children and adolescents with schizophrenia in medication-free research
S Kumra1, C Briguglio, M Lenane
1Child Psychiatry Branch, NIMH, Bethesda, MD 20892-1600, USA.
Insights
A 4-week medication-free period is safe for pediatric patients with treatment-refractory schizophrenia. This approach aids in accurate diagnosis and forms homogeneous groups for research on childhood-onset schizophrenia.
Area of Science:
- Child and Adolescent Psychiatry
- Neuroscience
- Clinical Psychology
Background:
- Ethical considerations arise from medication withdrawal in schizophrenia research.
- Pediatric patients with treatment-refractory schizophrenia require careful study regarding medication-free periods.
Purpose of the Study:
- To examine the risks and benefits of a medication-free period in pediatric patients with treatment-refractory schizophrenia.
- To assess the safety and utility of medication withdrawal for research and clinical purposes in this population.
Main Methods:
- 31 children and adolescents with treatment-resistant, childhood-onset schizophrenia participated.
- A 4-week medication-free period (washout) was implemented after obtaining parental consent.
- Patients underwent evaluations at baseline, post-washout, after an atypical neuroleptic trial, and at 2-4 year follow-up.
Main Results:
- 23% (7/31) received revised diagnoses (e.g., PTSD, atypical psychosis, personality disorder) after the drug-free period.
- 26% (8/31) experienced rapid, severe deterioration of schizophrenic symptoms, curtailing the washout.
- Three patients remained off neuroleptics at follow-up.
Conclusions:
- A 4-week medication-free period is safe for inpatient pediatric patients with treatment-refractory schizophrenia.
- Medication-free trials are clinically valuable and create homogeneous research cohorts.
- Hospitalization is essential for observing pediatric patients with psychotic symptoms during medication withdrawal.
Objective:
There has been an increasing focus on the ethical issues raised by studies requiring the withdrawal of effective medication in schizophrenic 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 treatment-resistant, childhood-onset schizophrenia. Parental consent was obtained so that patients could participate in a medication-free research period. Patients 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, seven patients (23%) were diagnosed with another disorder on the basis of data gained from the drug-free period and their lack of schizophrenic symptoms. Their revised diagnoses were posttraumatic stress disorder (N = 1), an atypical psychosis labeled "multidimensionally impaired" (N = 4), and personality disorder (N = 2). At follow-up, three of these patients remained free of neuroleptic therapy. For eight patients (26%), the washout was curtailed because of rapid and severe deterioration of their schizophrenic symptoms.
Conclusions:
For children and adolescents with treatment-refractory schizophrenia, a medication-free period can be conducted safely for at least 4 weeks for inpatients. Such trials are useful on clinical grounds and for providing homogeneous patient groups for research. This study also highlights the necessity of having access to hospitalization to observe children and adolescents with psychotic symptoms while medication free.