Shopsin 1975.
Methods | Study design: parallel, randomised controlled study | |
Participants |
Diagnosis: manic illness Method of diagnosis: not described Age: not described Sex: women; men. but no figures provided Location: Psychiatric Hospital of New York, Bellevue Medical Centre` Co‐morbidities: not described Adjunctive therapy: not described Adjunctive medication: not described |
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Interventions | Participants were randomly assigned to either: Experimental arm ‐ lithium N = 10 Duration: 21 days Treatment protocol: not described Therapist/face‐to‐face contact: not described Comparator arm ‐ chlorpromazine N = 10 Duration: 21 days Treatment protocol: not described Therapist/face‐to‐face contact: not described Comparator arm ‐ haloperidol N = 10 Duration: 21 days Treatment protocol: not described |
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Outcomes |
Primary outcome:
Secondary outcome:
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Notes | Funding source: "This investigation was supported in part by Public Health Service… MH17436 and MH04669" | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "random" |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | "All personnel involved in patient ratings were unaware of the lithium… levels, these being only known to the laboratory staff… psychiatrist assigning treatment." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition |
Selective reporting (reporting bias) | Low risk | Well reported |
Other bias | Unclear risk | Poorly described methodology so cannot rule out other biases |