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 |
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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) |
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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 |
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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 |
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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 |
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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. |