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

Ghaleiha 2016.

Study characteristics
Methods 10‐week parallel study of minocycline + risperidone versus placebo + risperidone
Participants Inclusion criteria:
  • children 3‐12 years

  • diagnosis of ASD based on DSM‐4 criteria

  • ABC‐I score of at least 12 at baseline

  • presence of behavioural problems such as aggression


Exclusion criteria: "Children with concomitant psychotic disorders, severe intellectual disability that made the diagnosis inconclusive (based on clinical judgment and reviewing prior neurocognitive testing and records), other DSM‐IV axis I or II disorders, seizure disorder, a history of alcohol or drug abuse, tardive dyskinesia, administration of antipsychotic medications within the past 6 months, as well as behavior therapy, and the presence of any significant active medical condition were excluded from the study".
Setting: psychiatric hospital
Dropouts/withdrawals: 2 participants in each group withdrew consent prior to week 5 (1st outcome measurement point)
Sample size: 50 (25 each group)
Mean age: 7.6 years
Gender: minocycline 17/23 male; placebo 18/23 male
IQ: details not provided
Baseline ABC‐I or other BoC: ABC‐I intervention group 21.26 (4.82), comparator group 19.91 (7.20)
Concomitant medications: participants were not allowed to be taking antipsychotics concomitantly.
Previous medications: details not provided
Interventions Intervention (minocycline + risperidone): minocycline 100 mg/day + tablet risperidone 1‐2 mg/day as intervention 10 weeks
Comparator (placebo + risperidone): risperidone 1‐2 mg/day + capsule placebo as control for 10 weeks. The maximum target dose of risperidone was defined as 1 mg/day for children weighing < 20 kg and 2 mg/day for those weighing ≥ 20 kg
Outcomes Primary outcomes:
  • ABC‐I (change from baseline) (Aman 1985)

  • AEs


Secondary outcomes: none reported
Notes Study start date: March 2013
Study end date: March 2015
Funding: "This study was supported by a grant from Tehran University of Medical Sciences to Dr. Shahin Akhondzadeh (Grant No. 20288)". Also, "The authors also affirm that there was no source of funding"
Conflicts of interest: 'the authors do not have any conflicts of interest"
Trial registry: IRCT201302201556N50
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients were randomised to receive either minocycline or placebo in a 1:1 ratio using a computer‐generated code.
Allocation concealment (selection bias) Low risk The assignments were kept in sealed opaque envelopes until data analysis.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Throughout the study, the person who administered the medications, the rater, the participants, and parents were blind to assignments. Independent people were responsible for treatment allocation and participant interviews.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Placebo was identical to the intervention medication (minocycline) in shape, size, colour, and taste and was dispensed by the investigational drug pharmacist. Throughout the study, the person who administered the medications, the rater, the participants, and parents were blind to assignments. Independent people were responsible for treatment allocation and participant interviews
Incomplete outcome data (attrition bias)
All outcomes Unclear risk 2 participants in each group discontinued (8% each group) and imputation was not used
Selective reporting (reporting bias) Low risk Outcomes reported match protocol
Other bias High risk
  • The contact author is also on the ethics committee at the university funding the study.

  • The contact author is a peer‐reviewer for one of the journals in which some of their studies are published.