Vishnupriya 2016.
Study characteristics | ||
Methods | Randomisation: randomised, computer‐generated Blinding: open‐label, no other details Duration: 24 weeks Country: no details |
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Participants | Diagnosis: first episode schizophrenia patients (DSM‐IV) N = 96 Age: 18‐40 years Sex: male and female Setting: no details History: on treatment with risperidone 2 mg twice/d for ≥ 2 months Excluded: unco‐operative and aggressive patients; patients with suicidal tendency; pregnant and lactating women; patients with history of liver disease, renal disease, cardiovascular disease, diabetes mellitus, hypertension, dyslipidaemia, substance abuse,seizure disorder, malignancy; patients with diagnosis other than schizophrenia; patients with mental retardation; patients taking other drugs that may affect body weight (carbamazepine, lithium, and topiramate, antidepressants, valproate and hormone replacement therapy); patients on a special diet and who do exercise for weight loss |
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Interventions |
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Outcomes |
Able to use:
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Notes | We contacted study authors to obtain additional data on body weight and laboratory measures that were not included in the published paper. We did not receive a response from them. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants who were initiated on risperidone 2 mg orally twice daily for ≤ 2 months for first‐episode schizophrenia were randomised using computer‐generated table into 2 groups |
Allocation concealment (selection bias) | High risk | No allocation concealment mentioned, however, the open‐label nature of the study puts it at high risk. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome unlikely to be biased by blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All the participants completed the study, and the results were analysed. |
Selective reporting (reporting bias) | Low risk | Study protocol unavailable, but all outcomes indicated in the methods section were reported on. |
Other bias | Low risk | No obvious bias |