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

Poyurovsky 2007.

Study characteristics
Methods Randomisation: randomised, random numbers table
Blinding: double‐blind, no other details
Duration: 6 weeks
Country: Israel
Participants Diagnosis: DSM‐IV schizophrenia or schizophreniform disorder
N = 59
Age: 29.9 years
Sex: male and female
Setting: inpatients
History: participants had none or < 4 weeks of antipsychotic drug exposure and a recommendation for olanzapine treatment by the treating physician.
Excluded: major mood disorder, aggressive or suicidal behaviour, medical illness that could affect body weight (e.g. diabetes mellitus and hypothyroidism) and obesity (BMI > 30 kg/m2)
Interventions

  1. Reboxetine (4 mg/d as 2 mg doses twice daily) in combination with fixed‐dose olanzapine (10 mg/d); N = 31

  2. Placebo (twice daily) in combination with fixed‐dose olanzapine (10 mg/d); N = 28
Outcomes Able to use:

  1. Primary outcomes

    1. Weight measure

      1. Body weight

      2. Change in body weight

    2. Other extractable outcomes

      1. Change in appetite

  2. Secondary outcomes

    1. Weight measure

      1. BMI

      2. Change in BMI

    2. Mental state

      1. Change in SAPS

      2. Change in SANS

      3. Change in CGI

      4. Change in HAM‐D

    3. Extrapyramidal symptoms

      1. Change in SAS

      2. Change in BAS


Unable to use:

  1. Laboratory test (data not available)

  2. ECG (data not available)

  3. Drug screening test (data not available)
Notes None of the participants were placed on a special diet or physical exercise programme for weight reduction.
69.5% study completers
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The participants were allocated according to entries on a table of random numbers to receive..." Pg 442
Allocation concealment (selection bias) Unclear risk Information is unavailable
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "All the study medications were dispensed in identical capsules, and patients received two capsules per day." Pg 443
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "All weight measurements were performed by a research assistant blinded to the patient's treatment assignment." Pg 443
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "The primary statistical analysis was by intention to treat and included all randomised participants." Pg 443
Quote: "Nine patients in each group discontinued the study medication..." Pg 444
Comment: > 90% of the data was analysed with ~70% study completers using an ITT analysis
Selective reporting (reporting bias) Unclear risk Study protocol is unavailable
Other bias Low risk No obvious bias