Skip to main content
. 2017 Jun 28;2017(6):CD009005. doi: 10.1002/14651858.CD009005.pub2

C +risperidone 2007.

Methods Allocation: randomised.
 Blinding: double‐blind.
 Duration: 6 weeks.
 Setting: outpatients.
 Design: parallel.
 Country: USA.
Participants Diagnosis: refractory schizophrenia (DSM‐IV).
 N = 24.
 Sex: 21 M, 3 F.
 Age: average 42.3 years (range 27‐55).
 History: displayed stable, residual psychiatric symptoms; failed at least two previous trials of antipsychotics prior to clozapine and currently treated with clozapine monotherapy for at least 6 months, at a stable dose for at least 8 weeks and with clozapine plasma levels of at 200 ng/mL, unless the clozapine dose necessary to achieve that level was not tolerated.
Interventions
  1. Combination therapy: clozapine + risperidone (N = 11).

  2. Monotherapy: clozapine + placebo (N = 13).


Schedule: risperidone 4 mg/day, clozapine 456 mg/day average (200 mg to 700 mg/day).
 Subjects received one capsule twice daily for three days, then two capsules twice daily for the rest of the study.
Outcomes ‐ Usable data ‐
  1. Leaving the study early.

  2. Clinical response: not clinically improved.

  3. Mental state: PANSS, SANS.


‐ Unable to use ‐
  1. Adverse events: AIMS, SAS, BAS (Skewed data); prolactin level (no SD reported, not able to impute as no similar mean); Systematic Assessment for Treatment Emergent Events (SAFTEE; no data reported).


‐ Not used in review ‐
  1. Calgary Depression Scale for Schizophrenia (CDSS).

Notes *The active 6‐week treatment period was preceded by a 2‐week single‐blind placebo lead‐in period to eliminate potential placebo‐responders.
ClinicalTrials.gov identifier NCT00289861.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants randomised in blocks of 10. No further details.
Allocation concealment (selection bias) Unclear risk No details provided.
Blinding (performance bias and detection bias) 
 All outcomes Low risk An independent research pharmacy prepared matching capsules that contained either 1 mg risperidone or placebo.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Twopatients in the placebo group and three patients in the risperidone group did not finish the study.
Selective reporting (reporting bias) High risk Not all expected outcomes reported.
Other bias Unclear risk Trial supported by a grant from the Stanley Medical Research Institute.