Weight gain management in patients with schizophrenia during treatment with olanzapine in association with nizatidine.
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.
Assunção
Sheila Seleri Marques
SS
Bristol Meyers, USA.
Ruschel
Sandra Inês
SI
Rosa
Lucena de Cássia Rodrigues
Lde C
Campos
João Alberto O
JA
Alves
Mercedes Jurema O
MJ
Bracco
Oswaldo Luis
OL
de Lima
Mauricio Silva
MS
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
D014150:Antipsychotic Agents; D006635:Histamine H2 Antagonists; D010919:Placebos; D001569:Benzodiazepines; D000077152:Olanzapine; D016567:Nizatidine