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

Novotny 2004.

Methods Parallel trial of single‐dose M‐chlorophenylpiperazine (m‐cpp) versus placebo
Participants Inclusion criteria:
  • aged 18‐53 years old

  • met diagnostic criteria for ASD according to the Autism Diagnostic Interview‐Research version and the DSM‐IV


Exclusion criteria: "meeting criteria for current or past psychotic disorders diagnosed by SCID – Axis disorders; reporting a history of seizures or medical illnesses"
Location/setting: USA
Sample size: oral m‐CPP 11, placebo 8
Number of withdrawals/dropouts: no LTFU reported
Gender: 10 male participants, 1 female participant
Mean age: 34.3 years
IQ: not reported
Baseline ABC‐I or other BoC: not reported
Concomitant medications: participants were required to be drug‐free for 2 weeks prior to study.
History of previous medications: not reported
Interventions Intervention (single dose of oral m‐CPP): 0.5 mg/kg at least 48 h apart from the placebo single dose, and after a drug‐free period of at least 2 weeks or 6 weeks for those on fluoxetine, and a 72‐h low monoamine diet
Comparator (single‐dose placebo): equivalent placebo
Outcomes Primary outcomes: self‐injurious behaviours (not reported)
Secondary outcomes: none reported
Timing of outcome assessments: baseline and at 60, 120, 180, 240 min (single dose)
Notes Study start date: not reported
Study end date: not reported
Source of funding: "supported in part by grants from the Seaver Foundation, National Alliance for Research on Schizophrenia and Depression, Cure Autism Now, National Alliance for Autism Research and grant 5 MO1 RR00071 for the Mount Sinai General Clinical Research Center from the National Center for Research Resources, National Institutes of Health.:
Conflicts of interest: none declared