BACKGROUND: This study compares the effect of clozapine and haloperidol and identifies other factors related to family burden as experienced by relatives of patients with refractory schizophrenia (DSM-III-R). METHOD: Of 423 patients participating in a multisite randomized clinical trial, 221 identified a family member who was actively involved in their care and who agreed to complete a standardized measure of family burden at 6 weeks and 3, 6, 9, and 12 months after randomization, simultaneous with comprehensive patient assessments. RESULTS: Patient factors most consistently correlated with greater family burden were symptom severity, days living in the community (i.e., not in the hospital), and frequency of family contact. Among family members, clozapine was associated with significantly (p = .048) greater reduction in feelings of dissatisfaction related to providing support to the patient, but not in objective measures of support, amount of worry the patient engendered, or days of missed employment or household activity. Although clozapine reduces symptoms, thus lowering family burden, it also increases days living in the community, which tends to increase family burden, perhaps canceling out the benefit to families of reduced symptoms. CONCLUSION:Clozapine has a small but significant effect on the experience of families of patients. This is the first study to demonstrate that effective pharmacotherapy may be of some benefit to families as well as to patients.
RCT Entities:
BACKGROUND: This study compares the effect of clozapine and haloperidol and identifies other factors related to family burden as experienced by relatives of patients with refractory schizophrenia (DSM-III-R). METHOD: Of 423 patients participating in a multisite randomized clinical trial, 221 identified a family member who was actively involved in their care and who agreed to complete a standardized measure of family burden at 6 weeks and 3, 6, 9, and 12 months after randomization, simultaneous with comprehensive patient assessments. RESULTS:Patient factors most consistently correlated with greater family burden were symptom severity, days living in the community (i.e., not in the hospital), and frequency of family contact. Among family members, clozapine was associated with significantly (p = .048) greater reduction in feelings of dissatisfaction related to providing support to the patient, but not in objective measures of support, amount of worry the patient engendered, or days of missed employment or household activity. Although clozapine reduces symptoms, thus lowering family burden, it also increases days living in the community, which tends to increase family burden, perhaps canceling out the benefit to families of reduced symptoms. CONCLUSION:Clozapine has a small but significant effect on the experience of families of patients. This is the first study to demonstrate that effective pharmacotherapy may be of some benefit to families as well as to patients.