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. 2023 Mar 6;2023(3):MR000055. doi: 10.1002/14651858.MR000055.pub2

Adelson 1962.

Study characteristics
Methods Type: clinical
Design: parallel
Objective: to investigate the effectiveness of 4 phenothiazine derivatives
Treatment duration: 4.5 months
Follow‐up duration (including treatment duration): 8 months
Washout between cross‐over periods: NA
Data Country: USA
Condition: schizophrenia
Number of people randomised: 48 to each placebo group (288 in total)
Number of people analysed: 48 in each placebo group (288 in total)
Comparisons Active placebo: scopolamine (maximum daily dose 1.50 mg) and chlorprophenpyridamine maleate (maximum daily dose 30 mg)
Standard placebo: lactose
Experimental intervention: 4 phenothiazines (doses in brackets are maximum daily doses): chlorpromazine (3000 mg), triflupromazine (750 mg), prochlorperazine (450 mg), perphenazine (240 mg)
Administration: oral
Outcomes Participant‐reported outcome: none
Observer‐reported outcome: MRSPP (Multidimensional Scale for Rating Psychiatric Patients, Hospital Form; also called Lorr scale); assessed at 4 months, 5.5 months (earliest post‐treatment assessment), and 8 months (latest follow‐up)
Harm outcome: number of side effects
Co‐intervention outcome: none
Terminology for active placebo "Active placebo" a priori
Scores and unpleasantness of the active placebo Adequacy: 3
Risk of therapeutic effect: 2
Unpleasant/neutral/pleasant: unpleasant
Funding and conflicts of interest Non‐industry funding, but drugs supplied by the industry. Conflicts of interest not reported.
Notes 15 people dropped out and were replaced with randomly selected substitutes: 2 on active placebo and 2 on inactive placebo (i.e. keeping number of participants in the groups at 48).
Risk of bias
Item Authors' judgement Support for judgement
Free from risk of bias arising from the randomisation process Unclear Stagger system. Allocation concealment not clearly described, but assignment carried out by a person not involved in the study. Study staff had no knowledge of the assignment. No indication of baseline differences. Replacements brought in for dropouts (n = 15, 2 for each placebo control intervention).
Free from risk of bias in selection of the reported result
All outcomes Unclear No information.