Ritsner 2010.
Methods | Allocation: randomised.
Blindness: double.
Duration: 8 weeks. Funding: none reported. |
|
Participants | Diagnosis: schizophrenia or schizoaffective disorder. SCID, DSM IV.
N = 58.
Age: average 35.8 years (SD 8.3), range 23 to 55 years.
Sex: 32 M, 12 F.
Setting: outpatient.
History: average duration of illness (years): PREG30 = 15.1 (8.0); PREG200 = 11.7 (7.7); DHEA400 = 10.3 (7.3); placebo = 11.1 (6.5).
Excluded: unstable medical condition, any significant medical (including prostate illness) or neurological illness, pregnant women, receiving mood stabilisers or any steroid hormonal supplement (e.g. oestrogen). Country: Israel. |
|
Interventions | 1. Pregnenolone (PREG30) 30 mg/day. yN = 16. 2. Pregnenolone (PREG200) 200 mg/day. N = 10. 3. DHEA 400 mg/d. N = 16. 4. Placebo identical capsules. N = 16. Other concurrent treatments: antipsychotic, anticholinergic, benzodiazepine medication continued from before the trial. PREG30: chlorpromazine equivalent 476.4 (337.6) mg/day. PREG200: chlorpromazine equivalent 585.0 (704.3) mg/day. DHEA: chlorpromazine equivalent 441.1 (276.2) mg/day. Placebo: chlorpromazine equivalent 621.3 (455.3) mg/day. |
|
Outcomes | Mental state: total psychotic symptoms (PANSS), positive psychotic symptoms (PANSS), negative psychotic symptoms (PANSS). Global state: leaving the study early. General functioning: GAF. Adverse events: general adverse events, extrapyramidal symptoms (ESRS, BARS). Unable to use: cognitive functioning. CANTAB including matching to sample (MTS), delayed matching to sample (DMS), pattern recognition (PRM), rapid visual information processing (sustained attention) (RVP) and stockings of Cambridge (SOC). Data not provided. Study authors reported significant improvement in DMS and MTS with pregnenolone 30 mg/d treatment. No significant effects of DHEA on cognitive function reported. |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The randomization procedure was performed using the Random Allocation Software, version 1.0" (pg 1353). |
Allocation concealment (selection bias) | Low risk | "The pharmacist conducted randomization of participants by using a random and equal block size for placebo, DHEA and PREG30 arms (with ratio 1.5:1 for PREG30 and PREG200 arms, respectively) and conducted blinding of the trial. The patient allocation details were coded and kept confidential until the trial was completed" (pg 1353). |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Double‐blind study design" (pg 1352). |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Double‐blind study design" (pg 1352). Participants and study personnel blinded. "The patient allocation details were coded and kept confidential until the trial was completed" (pg 1353). |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors blinded (pg 1353). |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | LOCF analysis described in methods (pg 1354): "Patients who completed the study (completers) were included in the statistical analysis. The LOCF procedure was used to analyze those subjects who completed at least four weeks (selected a priori) but failed to complete all eight weeks of the study (non‐completers)" (pg 1365): "Of the 58 patients randomly assigned to this trial, 14 patients dropped out." "More specifically 1,1,2, and 3 patients assigned to receive PREG‐30, PREG‐200, DHEA, and placebo, respectively, dropped out between four and six weeks, and seven patients dropped out between six and eight week." All 14 participants who left the the study early had completed at least 4 weeks of the trial. However, analysis was performed on 44, not LOCF (n = 58) Reasons for leaving the study early included lack of efficacy (n = 4), change in antipsychotic drugs (n = 3), loss to follow‐up (n = 5), non‐compliance (n = 2). |
Selective reporting (reporting bias) | Low risk | All outcomes reported. |