Skip to main content
. 2016 Dec 15;2016(12):CD006918. doi: 10.1002/14651858.CD006918.pub3

Geffen 2010.

Methods Allocation: randomised, a central randomisation scheme.
 Blindness: double blind, but unclear who is blinded.
 Duration: 5‐14 days suspension of other antipsychotics plus 6 weeks treatment period.
Settings: inpatients, 40 sites in India, Romania, and USA.
 Design: parallel.
Participants Diagnosis: schizophrenia (DSM‐IV‐TR).
 N = 363.
 Age: mean ˜ 34.2 years, SD ˜ 10.34 years.
 Sex: male 245, female 118.
Length of illness: mean ˜ 8.26 years, SD ˜ 8.92 years.
 Inclusion criteria: 18‐65 years old, acute exacerbation within 30 days, PANSS total score ≥ 70, at least 4 on any 2 of PANSS items (delusions, hallucinatory behaviours, conceptual disorganization, or suspiciousness/persecution), CGI ≥ 4.
 Exclusion criteria: a score of greater than 9 on the modified ISST, treatment refractory psychosis following 2 years of exposure to a therapeutic dose of antipsychotics, substance abuse, TD, use of mood stabilisers, history of blood cell disorder.
Interventions 1. Risperidone: 2 mg/d to 8 mg/d, N = 91.
 2. Placebo: no details, N = 93.
3. BL‐1020 low dose: 10 mg/d, N = 90*.
4. BL‐1020 high dose: 20 mg/d to 30 mg/d, N = 89*.
Outcomes Mental state.
Leaving the study early.
Global state: needing additional medication.
Adverse effects**.
Unable to use:
Clinical response. Global state: CGI‐I, CGI‐S. Mental state: PANSS score. Cognitive function: Mean and SD of each outcome were not reported.
Notes *We did not use the data from these groups, as the interventions are not relevant.
**For the concomitant medications rate reported in this study, we only extracted 2 drugs mentioned in our protocol.
Overall leaving the study early rate is less than 50%.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was performed via an interactive voice system.
Quote: "Randomisation was performed using an interactive voice response system, one randomisation scheme was generated across all sites (i.e. a central randomisation scheme)". (p1169)
Allocation concealment (selection bias) Low risk Allocation sequence was concealed by the "voice response system".
Quote: "when the drug was dispensed, the investigator called the interactive voice response system to assign the treatment code. This code number was used to identify the medication kit to be dispensed to the patient". (p1169)
Blinding (performance bias and detection bias) 
 All outcomes Low risk Double blind.
Quote: "This was a 6‐week, randomised, double‐blind, placebo‐controlled, parallel group phase 2 study". (p1168)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 20 participants in risperidone group and 37 participants in placebo group did not complete the trial, but ITT analysis was applied.
Selective reporting (reporting bias) Low risk All the measured outcomes were reported.
Other bias Low risk None obvious.