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. 2017 Jun 28;2017(6):CD009005. doi: 10.1002/14651858.CD009005.pub2

C +fluphen dec 2009.

Methods Allocation: randomised 1:1 ratio.
 Blinding: double‐blind.
 Duration: 12 weeks.
 Setting: inpatients.
Design: parallel.
Country: Iran.
Participants Diagnosis: schizophrenia (DSM).
 N = 28.
 Sex: females only.
 History: poor response to olanzapine, chronic schizophrenia.
Interventions
  1. Combination therapy: Olanzapine plus fluphenazine decanoate (N = 14).

  2. Monotherapy: Olanzapine plus placebo (N = 14).


Schedule: olanzapine 15 mg to 25 mg daily, fluphenazine decanoate week zero 6.25 mg/2 weeks IM, and increased by 6.25 mg increments, as needed or tolerated, in biweekly intervals, to a maximum of 25 mg/2 weeks by week eight.
Outcomes ‐ Usable data ‐
  1. Leaving the study early.

  2. Clinical response: CGI‐S.

  3. Mental state: SAPS, SANS.

  4. Adverse events: serious or requiring discontinuation, SAS.


‐ Not used in review ‐
  1. Schedule for Assessment of Insight (SAI).

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quasi‐randomised "Randomly entered in one of the two matching contemporaneous groups, alternately one patient after the other (one into the experiment group and the next into the control group, in sequence and back‐to‐back)."
Allocation concealment (selection bias) Unclear risk No details provided.
Blinding (performance bias and detection bias) 
 All outcomes Low risk "Double‐blind". "The placebo had been arranged in the shape of comparable vials, like the target drug". "The evaluators, as well, were unaware concerning the partition and the type of medications arranged for each group."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No losses to follow‐up reported.
Selective reporting (reporting bias) High risk Not all expected outcomes reported.
Other bias Unclear risk Funding not reported.