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. 2022 Oct 3;2022(10):CD013337. doi: 10.1002/14651858.CD013337.pub2

Poyurovsky 2002.

Study characteristics
Methods Randomisation: randomised, no other details
Blinding: double‐blind, no other details
Duration: 8 weeks
Country: Israel
Participants Diagnosis: DSM‐IV schizophrenia
N = 30
Age: 25.5 years
Sex: male and female
Setting: inpatients
History: < 4 weeks of antipsychotics exposure
Excluded: unco‐operative, aggressive, and suicidal patients and patients with medical illnesses that could affect body weight
Interventions
  1. Fluoxetine (20 mg/d) in combination with olanzapine (10 mg/d); N = 15

  2. Placebo in combination with olanzapine (10 mg/d); N = 15

Outcomes Able to use
  1. Primary outcomes

    1. Weight measures

    2. Mean body weight (completers data only)

    3. Average change in body weight (ITT analysis of data from all participants randomised)

    4. BMI

  2. Secondary outcomes

    1. Mental state

    2. SAPS

    3. SANS

    4. SAPS/SANS Dimensions (positive, negative, disorganised)

    5. HAM‐D

Notes Performed ITT analysis including dropouts.
74.2% study completers
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Information is unavailable
Allocation concealment (selection bias) Unclear risk Information is unavailable
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Information is unavailable
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Information is unavailable
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "Six subjects withdrew from the study within the first 4 weeks because of lack of response (2 patients receiving fluoxetine) and psychotic exacerbation (2 fluoxetine and 2 placebo patients)." Pg 1058
Comment: only 80% of the study population completed the study, which may effect results due to the small sample size (N = 31), however, ITT analyses reported by the study authors provides similar results as study completers.
Selective reporting (reporting bias) Unclear risk Study protocol is unavailable
Other bias Low risk No obvious bias