Granisetron as an add-on to risperidone for treatment of negative symptoms in
patients with stable schizophrenia: randomized double-blind placebo-controlled
study.
Author(s): Khodaie-Ardakani MR(1), Seddighi S, Modabbernia A, Rezaei F, Salehi B, Ashrafi M,
Shams-Alizadeh N, Mohammad-Karimi M, Esfandiari GR, Hajiaghaee R, Akhondzadeh S.
Affiliation(s): Author information:
(1)Razi Psychiatric Hospital, Welfare Sciences University, Iran. s.akhond@neda.net
Publication date & source: 2013, J Psychiatr Res. , 47(4):472-8
Some 5-HT3 antagonists such as ondansetron have shown beneficial effects on
negative symptoms of patients with schizophrenia. We aimed to evaluate the
efficacy of granisetron (another 5-HT3 antagonist) add-on therapy in the
treatment of negative symptoms of patients with stable schizophrenia. In a
randomized, double-blind, and placebo-controlled study, forty stable patients
with schizophrenia (DSM-IV-TR), were randomized to either granisetron (1 mg twice
daily) or placebo (twice daily) in addition to risperidone up to 6 mg/day for
eight weeks. The patients were assessed using positive and negative syndrome
scale (PANSS) and extrapyramidal symptom rating scale (ESRS) at baseline, week 4
and 8. Hamilton depression rating scale (HDRS) was used to assess depression at
baseline and week 8. Thirty-eight patients completed the trial. Granisetron group
showed a significantly greater improvement on negative subscale than the placebo
group at endpoint [t(38) = 6.046, mean difference (±95% CI) = 3.2(1.8-3.7),
P < 0.001]. The same effect was observed for total score [t(38) = 4.168, mean
difference (95% CI) = 3.2(1.6-4.7), P < 0.001]. However the placebo and
granisetron groups did not differ in their reduction of positive and general
psychopathology symptoms scores. HDRS scores and its changes did not differ
between the two groups. The ESRS score at week 4 was significantly lower in the
granisetron than the placebo group while the two groups showed similar ESRS score
at week 8. Frequency of other side effects was similar between the two groups. In
summary, granisetron add-on can safely and effectively reduce the primary
negative symptoms of patients with schizophrenia.
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