مشخصات پژوهش

صفحه نخست /Intranasal oxytocin as an ...
عنوان
Intranasal oxytocin as an adjunct to risperidone in patients with schizophrenia
نوع پژوهش مقاله چاپ شده
کلیدواژه‌ها
Oxytocin, risperidone, schizophrenia
چکیده
Background Impairment of oxytocinergic function and/or oxytocin receptor genetic abnormalities has been demonstrated in patients with schizophrenia. Oxytocin reverses emotional recognition deficit and might restore sense of trust in patients with schizophrenia. Some short-term studies have shown efficacy and tolerability of oxytocin in patients with schizophrenia. However, there is a lack of evidence on the efficacy and tolerability of oxytocin in patients with schizophrenia beyond 3 weeks. Objective The objective of this study was to assess the efficacy and tolerability of oxytocin intranasal spray (given as an adjuvant to risperidone) in patients with schizophrenia. Study Design This was an 8-week, randomized, double-blind, placebo-controlled study. Study Setting Inpatients of two large referral psychiatric hospitals in Iran were recruited for the study. Patients Forty patients (male and female gender) aged 18–50 years with a diagnosis of schizophrenia (DSM-IV-TR) who were on a stable dose of risperidone for a minimum of 1 month and who were chronically partially responsive to antipsychotic monotherapy were included in the study. Interventions The patients were randomly assigned to oxytocin intranasal spray (Syntocinon®; Novartis, Basel, Switzerland) or placebo intranasal spray containing normal saline (ACER, Tehran, Iran) for 8 weeks. Oxytocin spray was administered as 20 IU (five sprays) twice a day for the first week followed by 40 IU (ten sprays) twice a day for the following 7 weeks. Placebo spray was administered at the same dose as the oxytocin spray. In addition, participants were on a stable dose of risperidone (5 or 6 mg/day). Outcomes The patients were assessed using Positive and Negative Syndrome Scale (PANSS) at baseline and at weeks 0, 2, 4, 6 and 8. Primary outcomes were the differences in the PANSS scores between the two groups at the end of the trial. Adverse effects were recorded using a checklist and the Extrapyramidal Symptom Rating Scale (ESRS
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