Shader 1964.
Study characteristics | ||
Methods | Type: preclinical Design: cross‐over Objective: to find an active control substance that could later be used in a psychotic population under double‐blind conditions with an effective phenothiazine Treatment duration: 4 days per cross‐over period Follow‐up duration (including treatment duration): 4 days per cross‐over period Washout between cross‐over periods: 9 days |
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Data | Country: USA Condition: psychiatric symptoms in healthy participants Number of people randomised: 20 Number of people analysed: 20 in each placebo group |
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Comparisons | Active placebo: phenobarbital (50 mg) and atropine sulphate (0.3 mg) 4 times daily Standard placebo: lactose Experimental intervention: none Administration: oral |
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Outcomes | Participant‐reported outcome: Revised Clyde Mood Scale (self‐sort) Observer‐reported outcome: Revised Clyde Mood Scale (observer‐sort) Harm outcome: symptoms and side effects questionnaire Co‐intervention outcome: none |
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Terminology for active placebo | "Active control" a priori (also uses the term "active placebo" elsewhere in the introduction) | |
Scores and unpleasantness of the active placebo | Adequacy: 3
Risk of therapeutic effect: 1 Unpleasant/neutral/pleasant: unpleasant |
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Funding and conflicts of interest | Non‐industry funding. Conflicts of interest not reported. | |
Notes | This is a 2‐phase study; we were only interested in phase I. | |
Risk of bias | ||
Item | Authors' judgement | Support for judgement |
Free from risk of bias arising from the randomisation process | Unclear | No information. |
Free from risk of bias in selection of the reported result All outcomes | Unclear | No information. |