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A randomized, double-blind comparison of risperidone versus low-dose risperidone plus low-dose haloperidol in
Ching-Hua Lin1, Chao-Chan Kuo, Li-Shiu Chou
1Kai-Suan Psychiatric Hospital, Kaohsiung, Taiwan.
Journal of Clinical Psychopharmacology
|September 4, 2010
Summary
Risperidone monotherapy for schizophrenia showed similar efficacy to a combination of low-dose risperidone and haloperidol. However, monotherapy resulted in higher prolactin levels and extrapyramidal symptoms.
Area of Science:
- Psychiatry and Pharmacology
- Neuroscience and Clinical Therapeutics
Background:
- Antipsychotic drug combination therapy for schizophrenia, excluding clozapine, lacks clear risk-benefit data.
- Risperidone monotherapy presents a potential alternative, but its comparative safety and efficacy require investigation.
Purpose of the Study:
- To compare the efficacy and safety of risperidone monotherapy against a combination of low-dose risperidone and haloperidol in schizophrenia patients.
- To evaluate psychopathological improvements, quality of life, and adverse event profiles between the two treatment strategies.
Main Methods:
- A 6-week, double-blind study randomized 88 schizophrenia patients into two groups: risperidone monotherapy (4-mg/d) or combination therapy (2-mg/d risperidone + 2-mg/d haloperidol).
- Efficacy was assessed using Clinical Global Impression-Severity, Positive and Negative Syndrome Scale, Calgary Depression Scale, Global Assessment of Functioning, and SF-36.
- Safety monitoring included prolactin levels, extrapyramidal symptoms (Simpson-Angus Scale), metabolic parameters, and vital signs.
Main Results:
- Both treatment groups demonstrated similar demographic characteristics, response rates (≥30% reduction in PANSS), and improvements in psychopathology and quality of life.
- The risperidone monotherapy group exhibited significantly higher increases in prolactin levels (P=0.04) and Simpson-Angus Scale scores (P=0.04), with greater biperiden use (P=0.045).
- No significant differences were observed in weight changes, vital signs, QTc interval, liver/renal function, glucose, or lipid profiles between the groups.
Conclusions:
- Risperidone monotherapy may lead to elevated prolactin levels and increased extrapyramidal symptoms compared to a low-dose combination of risperidone and haloperidol.
- Both treatment strategies showed comparable efficacy, quality of life outcomes, and overall safety profiles.
- Further long-term investigations are necessary to fully elucidate the risk-benefit balance of these treatment approaches in schizophrenia.
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