White 1981.
| Methods | Randomisation: implied randomisation. Blinding: double‐blind. Duration: 4 weeks. Design: parallel. Location: not indicated. Setting: inpatients. |
|
| Participants | Diagnosis: paranoid schizophrenia (N = 17), non‐paranoid schizophrenia (N = 22). N = 39. Gender: 18M, 21F. Age: mean 28.3 years. History: duration stable: not indicated, duration of illness: not indicated, number of previous hospitalisations: not indicated, age at onset: not indicated, severity of illness: not indicated, baseline antipsychotic dose: not indicated. |
|
| Interventions | 1. Haloperidol: fixed/flexible dose: not indicated, dose range: 2 mg to 100 mg/day, mean dose: 28 mg/day. N = 21. 2. Mesoridazine: fixed/flexible dose: not indicated, dose range: 100 mg to 800 mg/day, mean dose: 421 mg/day. N = 18. “The protocol assumed a dosage equivalency of 2 mg haloperidol to 25 mg mesoridazine.” Rescue medication: concomitant antiparkinsonism medications were allowed. |
|
| Outcomes | Examined: Global state general: Clinical Global Impression (CGI). Mental state general: Brief Psychiatric Rating Scale (BPRS). Adverse effects: at least one movement disorder, dystonia, use of antiparkinson medication. Unable to use: Mental state specific: Dysphoric Response Index (DRI) calculated from the BPRS (no raw data available). |
|
| Notes | Study participants were “39 recently hospitalized inpatients, diagnosed schizophrenic according to the criteria of Feighner 1972, with modification to include illness less than 6 months in duration.” 19 participants had a process schizophrenia and twenty participants had a reactive schizophrenia. “Subjects received medication intramuscularly for the first 24h and orally thereafter.” The main aim of the study was “to test the hypothesis that a BPRS‐derived index of dysphoria may predict overall clinical outcome on such a neuroleptic trial” |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No randomisation mentioned in the publication, but the trial was described as “double‐blind.” Thus it was implied that the study was randomised. |
| Allocation concealment (selection bias) | Unclear risk | No further details. |
| Blinding (performance bias and detection bias) (performance bias) | Unclear risk | “Double‐blind”. No further details. |
| Blinding (performance bias and detection bias) (detection bias) | Unclear risk | “Double‐blind”. No further details. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The study did not address this outcome; insufficient information to permit judgment concerning incomplete outcome data. |
| Selective reporting (reporting bias) | High risk | The outcome data were not fully addressed (no raw data for the DRI). Only the “commonest side effects” were reported. |
| Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists. |
General abbreviations:
DSM‐II, ‐III, ‐III‐R, ‐IV = various versions of the Diagnostic and Statistical Manual of Mental Disorders; F = female; ICD = International Classification of Diseases; i.m. = intramuscular; M = male; n = number of participants; mg = milligram; SD = standard deviation; SE = standard error.
Rating scales:
AIMS = Abnormal Involuntary Movement Scale; BPRS = Brief Psychiatric Rating Scale; CGI = Clinical Global Impression; CNS‐RS = Concise Negative Symptoms Rating Scale; DOTES = Dosage Record Treatment Emergent Symptom Scale; DRI = Dysphoric Response Index; ESFR = Evaluation of Social Functioning Rater; GH = Global Hostility Scale; GP = Global Paranoia Scale; HAM‐D = Hamilton Depression Rating Scale; HPRSD = Hamilton Psychiatric Rating Scale for depression; IMPS = Inpatient Multidimensional Psychiatric Scale; MMPI = Minnesota Multiphasic Personality Inventory; MRS = Montgomery Rating Scale; NGI = Nurses´ Global Impressions; NOSIE = Nurses Observation Scale for Inpatient Evaluation; OBRS = Oklahoma Behavior Rating Scale; PIP = Psychotic Inpatient Profile; REPS = Reversible Extrapyramidal Symptom Rating Scale; RSQPSS = Rating Scale for Quantification of Psychotic Symptom Severity; SANS = Scale for Assessment of Negative Symptoms; SAPS = Scale for Assessment of Positive Symptoms; SRSS = Lipman‐Rickels Self‐Rating Symptom Scale; TESS = Treatment Emergent Symptom Scale; WBRS = Ward Behaviour Rating Scale.