Van Praag 1976.
Methods | Allocation: randomised. Blindness: double (implied). Duration: 10 days (preceded by 5 to 10 days wash‐out). Setting: inpatient, single‐centre. | |
Participants | Diagnosis: acute psychosis (n = 3 organic psychosis; n = 13 psychogenic psychosis; and n = 8 acute schizophrenia).
N = 28*.
Age: 19 ‐ 69 years, mean ˜ 35 years.
Sex: 15 F, 9 M.
History: acute, inpatient. Included: according to independent views of attending physician and psychiatrist/ supervisor, the participant showed signs of delusions and/ or hallucinations (Lowe 1973). Excluded: deep melancholia (i.e. deep endogenous depression with delusions of guilt, sin and/or poverty). Consent: not stated. |
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Interventions | 1. Perphenazine: 2, 4 and 8 mg per capsule, 3 capsules daily according to constitution, range 0 to 24 mg daily, mean 21 mg daily, n = 15.
2. Clozapine: 50, 100 and 200 mg per capsule, 3 capsules daily according to constitution, range 0 to 600 mg daily, mean 300 mg daily, n = 13. All daily doses determined by a psychiatrist not engaged in scoring; flexible dosing scheme. |
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Outcomes | Leaving the study early.
Adverse events. Unable to use ‐ Global state: no better or worse (no data). Mental state: BPRS (only significance tests). Laboratory tests (no data). |
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Notes | Only 24 participants were evaluated and described. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised: no further details. |
Allocation concealment (selection bias) | Unclear risk | No details. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind: implied ‐ identical capsules. Quote, "raters and patients were unaware of the type of medication or its dosage; nor were they informed of the biochemical results" (p549). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Four participants (n = 3 receiving perphenazine; n = 1 receiving clozapine) failed to complete the study. All cases were due to presence of severe motor unrest, anxiety or aggression non‐responsive to permitted medication. ITT used. |
Selective reporting (reporting bias) | Unclear risk | No means or SD reported for scale data. |
Other bias | Unclear risk | Funding: not stated. Raters: not stated to be independent of treatment. |