Hanlon 1969.
| Methods | Allocation: stratified randomisation.
Blindness: double.
Design: parallel.
Duration: 32 days (short‐term trial duration). Location: not indicated. Setting: inpatients. |
|
| Participants | Diagnosis: schizophrenia (N = 135), not indicated (N = 55) (research psychiatrists´ diagnoses). History: 75% of the patients were severely ill with at least one previous hospitalisation. N = 190. Age: mean 36 years. Sex: 60 M, 130 F. | |
| Interventions | 1. Chlordiazepoxide: mean dose: 29 mg/d + thioridazine 468 mg/d. N = 65. 2. Placebo + thioridazine: mean dose: 470 mg. N = 61. 3. Imipramine: mean dose: 75 mg/d + thioridazine 429 mg/d. N = 64. | |
| Outcomes | Leaving the study early.
Leaving the study early due to adverse effects.
Leaving the study early due to inefficacy of treatment.
Global state: Global impression.
Adverse effects: blurred vision, constipation, drowsiness, dry mouth, headache, insomnia, nasal congestion, palpitation, parkinsonism, vertigo. Unable to use: Global state: CGI (incomplete numbers). Mental state: IMPS, SGPG, Group Behavior Scale, MMPI, Depression Index (incomplete numbers). Behaviour: NOSIE (incomplete numbers). |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomly assigned “within sex”; no further details. |
| Allocation concealment (selection bias) | Unclear risk | No further details. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | “Double‐blind”, no further details. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | “Double‐blind”, no further details. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The attrition was rather low in the thioridazine plus placebo group (4.9%) but moderate in the thioridazine plus chlordiazepoxide group (16.9%), overall 11.1%. The trial authors provided a modified completer‐analysis. |
| Selective reporting (reporting bias) | High risk | The outcomes that are of interest in the review were not fully addressed (e.g. SDs are missing). |
| Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists. |