Nachshoni 2005.
Methods | Allocation: randomised.
Blindness: double.
Duration: 7 days. Funded by: no extramural funding (source: study author). |
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Participants | Diagnosis: schizophrenia, schizoaffective disorder. SCID, DSM III‐R.
N = 34.
Age: average ˜ 40 years (SD ˜ 12), range 19 to 64 years.
Sex: 23 M, 7 F.
Setting: inpatient.
History: unclear.
Excluded: receiving steroids, pregnant women, patients engaged in substance abuse, patients with significant medical or neurological illness. Country: Israel. |
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Interventions | 1. DHEA: dose 100 mg/day( 50 mg bid at 8am and 8pm). N = 18. 2. Placebo: N = 16. Other concurrent treatments: All participants had received fixed doses of antipsychotic medications for at least 3 weeks before study commencement, and no change in dosage or medication was permitted for the trial duration. Anti‐EPS agents were withdrawn with a 2‐day washout period before randomisation. |
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Outcomes | Mental state: total psychotic symptoms (BPRS). General functioning: GAF. Adverse events: general adverse events and general extrapyramidal symptoms (SHRS). Unable to use: adverse events ‐ extrapyramidal symptoms ‐ UKU (not reported). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "subjects were randomised (by means of random number generation)..." (pg 252). |
Allocation concealment (selection bias) | Low risk | Quote (from correspondence): "Randomization numbers provided by statistician to research assistant assigning study medication and maintained under lock and key in concealed fashion." |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participant/providers: Yes. Quote: "...randomised to receive either DHEA at a fixed dose of 100 mg/day or placebo in double‐blind fashion..." (pg 252). Outcome assessors blind (from correspondence). |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind" ‐ probably undertaken. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors blind (from correspondence). |
Incomplete outcome data (attrition bias) All outcomes | High risk | Missing outcome data for 4 participants not accounted for in analysis. |
Selective reporting (reporting bias) | High risk | Study authors unable to analyse tardive dyskinesia or dystonia because few participants had tardive dyskinesia (10%) or dystonia (0%). UKU scores not reported. |
Other bias | High risk | Only 11/30 participants exhibited akathisia, and slight differences in baseline akathisia symptoms were noted between groups. Sample size was small and the intervention was of short duration. |