A double-blind study of adjunctive sertraline in haloperidol-stabilized patients with chronic schizophrenia.

We conducted a placebo-controlled, randomized, double-blind, 8-week trial of sertraline added to haloperidol treatment in patients with schizophrenia to evaluate changes in clinical measures and pharmacokinetic interactions with haloperidol. In addition to their haloperidol regimen, 36 inpatients with chronic schizophrenia were randomly assigned to receive capsulized sertraline (50 mg/day; N = 18) or identically capsulized placebo (N = 18) for 8 weeks. The results from the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI) Scale, Simpson-Angus Extrapyramidal Effects (S-A) Scale, and plasma concentration levels of haloperidol and reduced haloperidol were examined at baseline and 2, 4, 6, and 8 weeks of treatment. No significant differences between the three PANSS factors (positive, negative, general psychopathology) scores, CGI Scale scores, or S-A Scale scores were recorded at any point during sertraline and placebo treatment. Neither plasma haloperidol or reduced haloperidol concentrations was changed significantly at any point during the sertraline and placebo treatments. In this study, the addition of sertraline 50 mg to the treatment regimen of inpatients did not differ significantly from the placebo effect on positive and negative symptoms and extrapyramidal side effects. The results further indicate that the pharmacokinetics of haloperidol are seemingly unaffected by sertraline.

RCT Entities:   Population Interventions Outcomes