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. 2017 Jun 28;2017(6):CD009005. doi: 10.1002/14651858.CD009005.pub2

A +reserpine 1957.

Methods Allocation: randomised.
 Blinding: double‐blind.
 Duration: 6 months (2 months baseline, 3 months before cross‐over to a second follow up of 1 month).
 Setting: inpatients.
 Design: cross‐over.
 Country: USA.
Participants Diagnosis: regressed schizophrenic patients (regression, withdrawal, and intellectual disorganisation).
 N = 32.
 Sex: not reported.
 Age: average ˜ 35 years.
 History: chronic, regressed schizophrenia, had received prolonged courses of ECT, insulin, and "total push" programs, without lasting benefit.
Interventions
  1. Combination therapy: reserpine + chlorpromazine (N = 10).

  2. Monotherapy: reserpine (N = 10).

  3. Monotherapy: chlorpromazine (N = 10).


Schedule: reserpine 1 mg to 4 mg/day + chlorpromazine 100 mg to 400 mg/day, reserpine 4 mg to 8 mg/day, chlorpromazine 200 mg to 1200 mg/day.
The medications were given at noon and 8:00 each day.
Outcomes ‐ Usable data ‐
  1. Leaving the study early.

  2. Clinical response: not clinically improved.

  3. Adverse events: serious or requiring discontinuation.


‐ Unable to use ‐
  1. Behaviour: MACC Behavioural Adjustment Scale, observation of behaviour (results illegible).

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details provided.
Allocation concealment (selection bias) High risk Medications were designated with an alphabetical code.
Blinding (performance bias and detection bias) 
 All outcomes Low risk Neither raters nor participants were aware of the nature or quantity of drug given. Participants were given an identical number of capsules regardless of the individual dosage.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Two patients dropped out because of adverse events and were replaced by two reserve patients who had previously been receiving placebos.
Selective reporting (reporting bias) High risk Not all expected outcomes reported.
Other bias Unclear risk Funding not reported.