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. 2023 Oct 9;2023(10):CD011769. doi: 10.1002/14651858.CD011769.pub2

Nikvarz 2017.

Study characteristics
Methods 8‐week parallel trial of risperidone versus memantine
Participants Inclusion criteria:
  • children 4‐17 years

  • diagnosis of autism based on the DSM‐4‐TR

  • unsatisfactory response to previous drugs

  • participants with epilepsy allowed but only if seizure‐free within the month prior to study start.


Exclusion criteria:
  • currently receive drugs that satisfactorily treat symptoms of autism

  • patients with epilepsy and one or more seizures in the month prior to the study commencing

  • other neurological conditions

  • "a history of substance abuse, neuroleptic malignant syndrome, severe allergic reactions to risperidone or memantine, any cardiac disease, hematologic malignancy, acute kidney or liver failure, consumed stimulant drugs"

  • pregnant


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.
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.
Outcomes Primary outcomes:

Secondary outcomes: none reported
Timing of outcome assessments: baseline, week 4 and week 8 (endpoint)
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."
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