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. 2019 Jun 1;2019(6):CD004048. doi: 10.1002/14651858.CD004048.pub4

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
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 armchlorpromazine
N = 10
Duration: 21 days
Treatment protocol: not described
Therapist/face‐to‐face contact: not described
Comparator armhaloperidol
N = 10
Duration: 21 days
Treatment protocol: not described
Outcomes Primary outcome:
  1. Clinical global comparison


Secondary outcome:
  1. CGI

  2. BPRS

  3. SCI

  4. NOSIE

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