title: Weight gain management in patients with schizophrenia during treatment with olanzapine in association with nizatidine.
abstract: OBJECTIVE
  Weight gain is associated with treatment with many psychotropic agents. Nizatidine, H2 receptor antagonist, has been proposed to have weight-reducing effects. This was a 12-week, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of nizatidine in reducing/limiting weight gain in patients with schizophrenia who have been under treatment with olanzapine.
  
  
  METHODS
  Patients receiving olanzapine (2 to 6 months) and weight gain >or= 5% of their body weight during olanzapine treatment were randomly assigned to receive nizatidine 600 mg or placebo for up to 12 weeks. Change in psychopathology was assessed using Brief Psychiatric Rating Scale scores from baseline to endpoint. Safety was assessed using the Safety Assessed Software, assessment of glucose and lipid blood levels, and treatment-emergent adverse events.
  
  
  RESULTS
  Out of 54 patients enrolled in this analysis, 45 completed the protocol. The mean weight change prior randomization was 7.6 kg and 7.3 kg for those randomized to placebo and nizatidine, respectively (p = 0.828). Patients receiving placebo and nizatidine had a mean weight gain of 12.3% (0.7 kg) and 12% (1.1 kg) from baseline to endpoint, respectively (p = 0.9). Patients from both groups experienced a statistically significant decrease on the Brief Psychiatric Rating Scale mean score from baseline to endpoint. Treatment-emergent adverse events were reported by 18.5% and 25.9% on the placebo and nizatidine group, respectively. There were no statistically significant differences in glucose and lipid blood levels from baseline to endpoint and between groups.
  
  
  CONCLUSIONS
  The concomitant use of olanzapine with nizatidine was not effective in controlling weight gain in patients who had previously gained weight during treatment with olanzapine when compared to placebo.
authors.affiliation: Bristol Meyers, USA.
authors.forename: Sheila Seleri Marques
authors.initials: SS
authors.lastname: Assunção
authors.forename: Sandra Inês
authors.initials: SI
authors.lastname: Ruschel
authors.forename: Lucena de Cássia Rodrigues
authors.initials: Lde C
authors.lastname: Rosa
authors.forename: João Alberto O
authors.initials: JA
authors.lastname: Campos
authors.forename: Mercedes Jurema O
authors.initials: MJ
authors.lastname: Alves
authors.forename: Oswaldo Luis
authors.initials: OL
authors.lastname: Bracco
authors.forename: Mauricio Silva
authors.initials: MS
authors.lastname: de Lima
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000009:adverse effects*; D001569:Benzodiazepines / Q000009:adverse effects; D015992:Body Mass Index; D010054:Brief Psychiatric Rating Scale; D004311:Double-Blind Method; D004507:Education, Nursing, Associate; D005260:Female; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016567:Nizatidine / Q000627:therapeutic use*; D009765:Obesity / Q000139:chemically induced / Q000517:prevention & control*; D000077152:Olanzapine; D010919:Placebos; D012559:Schizophrenia / Q000188:drug therapy*; D015430:Weight Gain / Q000187:drug effects
chemical_list: D014150:Antipsychotic Agents; D006635:Histamine H2 Antagonists; D010919:Placebos; D001569:Benzodiazepines; D000077152:Olanzapine; D016567:Nizatidine