Maintenance treatment of schizophrenia with risperidone or haloperidol: 2-year outcomes

Am J Psychiatry. 2003 Aug;160(8):1405-12. doi: 10.1176/appi.ajp.160.8.1405.


Objective: Most controlled studies comparing second-generation and conventional antipsychotics have focused on the acute treatment of schizophrenia. The authors compared symptom outcomes, side effects, and social adjustment in stable schizophrenia outpatients who received 2 years of maintenance treatment with risperidone or haloperidol.

Method: This was a 2-year, randomized, double-blind comparison of 6 mg of risperidone versus haloperidol in 63 patients with stabilized DSM-IV schizophrenia. Study patients also received 15 months of standard behavioral skills training or enhanced training with a case manager who promoted patients' use of their skills in the community.

Results: The risk of psychotic exacerbations and the risk of leaving the study were similar for both drug treatment groups. However, patients who received both risperidone and the enhanced community-based skills training were more likely to remain in the study than those in the other treatment groups. Patients demonstrated significant improvement in score on the Brief Psychiatric Rating Scale over time with both medications. There were no between-group differences in cluster scores for thought disturbance, hostile-suspiciousness, and withdrawal-retardation. A significant between-group difference favoring risperidone was found for the anxious-depression cluster. Risperidone resulted in significantly greater reductions in tremor and akathisia and greater improvements in most items on the SCL-90-R.

Conclusions: When compared with patients given a low dose of haloperidol, risperidone-treated patients experienced similar improvements in positive and negative symptoms and similar risks of psychotic exacerbations. However, risperidone-treated patients appeared to feel subjectively better, as indicated by less anxiety and depression and fewer extrapyramidal side effects.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Ambulatory Care
  • Antipsychotic Agents / therapeutic use*
  • Behavior Therapy
  • Brief Psychiatric Rating Scale
  • Combined Modality Therapy
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Haloperidol / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Risperidone / therapeutic use*
  • Schizophrenia / drug therapy
  • Schizophrenia / prevention & control*
  • Schizophrenic Psychology
  • Social Adjustment
  • Treatment Outcome


  • Antipsychotic Agents
  • Haloperidol
  • Risperidone