Nikvarz 2017.
Study characteristics | ||
Methods | 8‐week parallel trial of risperidone versus memantine | |
Participants | Inclusion criteria:
Exclusion criteria:
Setting/location: Roozbeh Psychiatric Hospital, Iran Sample size: 34, memantine (18 participants), risperidone (16 participants) Number of dropouts/withdrawals: 1 participant in the risperidone group did not complete the trial due to a change in psychiatrist. 3 participants in the memantine group did not complete the trial ‐ all reportedly due to a lack of therapeutic response in first 2 weeks of trial. Mean age: 6.7 years IQ: details not provided Gender: memantine 13/15 male; risperidone 10/15 male Baseline ABC‐I scores: 21.8 Concomitant medications: details not provided Previous medications: risperidone: 2 in risperidone group and 4 in memantine group had previously taken risperidone; aripiprazole: 2/15 in memantine group and zero from risperidone group had previously taken aripiprazole. |
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Interventions | Intervention (memantine) for 8 weeks: started at a once‐daily dose of 0.2 mg/kg/day then increased to 0.3 mg/kg/day in the 2nd week and ultimately to 0.4 mg/kg/day in the 3rd week. The maximum daily dose of memantine was 20 mg/day. Comparator (risperidone) for 8 weeks: "Risperidone was started at 0.02 mg/kg/day then increased to 0.04 mg/kg/day at week 2" up to a maximum of "0.06mg/kg/day at the third week." The maximum daily dose of risperidone was 3mg/day. |
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Outcomes | Primary outcomes:
Secondary outcomes: none reported Timing of outcome assessments: baseline, week 4 and week 8 (endpoint) |
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Notes | Study start date: April 2012 Study end date: March 2013 Funding: "This study was supported by Tehran University of Medical Sciences (TUMS) (Grant number: 91‐01‐33‐16991)." Conflicts of interest: "The authors declare no conflict of interest." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sample size was 30. Patients were randomly allocated to receive risperidone or memantine based on simple, balanced, blocked randomisation. |
Allocation concealment (selection bias) | Unclear risk | Although referred to as "simple balanced blocked randomisation", no information on how allocation was concealed |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label trial |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No information beyond it being "open label", so assume unblinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Data not imputed for participants who discontinued |
Selective reporting (reporting bias) | Unclear risk | Difficult to know for certain without seeing study protocol |
Other bias | Low risk | No other sources of bias identified |