title: A placebo-controlled trial of fluoxetine added to neuroleptic in patients with schizophrenia.
abstract: Following a 2-week placebo lead-in, schizophrenic patients were randomly assigned to fluoxetine 20 mg/day or placebo added to depot neuroleptic for a 6-week, double blind trial. All patients had received a stable dose of depot neuroleptic for at least 6 months and did not meet criteria for depression. Serum samples were obtained at baseline and at weeks 4 and 6. Scores on the negative symptom subscale of the Brief Psychiatric Rating Scale (BPRS) were significantly lower at week 6, controlling for baseline scores, in patients receiving fluoxetine (n = 20) compared to patients receiving placebo (n = 21). Measures of psychosis, depression, global functioning and extrapyramidal symptoms (EPS) did not differ between groups at week 6. Fluoxetine administration was associated with a mean 65% increase in serum fluphenazine concentrations in 15 patients and a mean 20% increase in serum haloperidol concentrations in three patients. The change in negative symptoms at week 6 did not correlate with serum concentrations of fluoxetine or norfluoxetine, but did inversely correlate with S-norfluoxetine, an active stereoisomer of fluoxetine. For these chronically ill patients, fluoxetine significantly improved negative symptoms and did not worsen EPS, despite causing substantial elevation in serum concentrations of neuroleptics.
authors.affiliation: Freedom Trail Clinic, Boston, MA 02114, USA.
authors.forename: D C
authors.initials: DC
authors.lastname: Goff
authors.forename: K K
authors.initials: KK
authors.lastname: Midha
authors.forename: O
authors.initials: O
authors.lastname: Sarid-Segal
authors.forename: J W
authors.initials: JW
authors.lastname: Hubbard
authors.forename: E
authors.initials: E
authors.lastname: Amico
mesh_terms: D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005473:Fluoxetine / Q000008:administration & dosage* / Q000097:blood; D005476:Fluphenazine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood; D006220:Haloperidol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood; D006801:Humans; D008297:Male; D011569:Psychiatric Status Rating Scales; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology
chemical_list: D005473:Fluoxetine; C033563:haloperidol decanoate; C011825:fluphenazine depot; D006220:Haloperidol; D005476:Fluphenazine