title: Fluphenazine vs placebo supplementation for prodromal signs of relapse in schizophrenia.
abstract: BACKGROUND
  We studied the effectiveness of treating patients with low doses of fluphenazine decanoate and supplementing them with oral fluphenazine when there was evidence of prodromal symptoms of psychotic exacerbations.
  
  
  METHODS
  Eighty schizophrenic patients who were receiving 5 to 10 mg of fluphenazine decanoate every 2 weeks were monitored for prodromal symptoms using an idiosyncratic prodromal rating scale. When patients met our criteria for a prodromal episode, they were randomly assigned to a double-blind comparison of oral fluphenazine hydrochloride (5 mg twice daily) or a placebo for the current and future prodromal episodes. We compared rates of psychotic exacerbations in the two treatment groups.
  
  
  RESULTS
  Thirty-six patients (45%) met the criteria for a prodrome at some point during the trial and were randomized to drug or placebo. Using survival analysis during the entire 2 years, we did not find a significant difference between fluphenazine and placebo in the likelihood that a prodrome would continue to an exacerbation. Survival analysis beginning at the start of the second year of treatment did indicate a significant reduction in exacerbation risk for patients receiving drug supplementation (P = .032). Similarly, there was no difference between the two groups in the proportion of time at risk spent in exacerbation during the first year, but patients receiving active drug supplementation spent less time in an exacerbated state in the second year (P = .05).
  
  
  CONCLUSIONS
  Our treatment strategy appeared to be effective for some patients, particularly those who were able to remain in the study beyond the first year. Although the occurrence of a prodrome was a fairly good marker that a patient was at high risk of ultimate exacerbation with our low-dose maintenance protocol, prodromes were not highly sensitive indicators of imminent exacerbation.
authors.affiliation: West Los Angeles, Veterans Affairs Medical Center, Brentwood Division, Calif.
authors.forename: S R
authors.initials: SR
authors.lastname: Marder
authors.forename: W C
authors.initials: WC
authors.lastname: Wirshing
authors.forename: T
authors.initials: T
authors.lastname: Van Putten
authors.forename: J
authors.initials: J
authors.lastname: Mintz
authors.forename: J
authors.initials: J
authors.lastname: McKenzie
authors.forename: K
authors.initials: K
authors.lastname: Johnston-Cronk
authors.forename: M
authors.initials: M
authors.lastname: Lebell
authors.forename: R P
authors.initials: RP
authors.lastname: Liberman
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D000328:Adult; D000553:Ambulatory Care; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005476:Fluphenazine / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D012008:Recurrence; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D010919:Placebos; D005476:Fluphenazine