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

Modabbernia 2014.

Study characteristics
Methods Randomisation: randomised, blocked procedures
Blinding: double‐blind, participant, caregiver, investigator, outcomes assessor
Duration: 8 weeks
Country: Iran
Participants Diagnosis: schizophrenia (DSM IV‐TR and SCID‐1)
N = 48
Age: 18‐65 years
Sex: male and female
Setting: academic psychiatric hospital (Shafa Hospital, affiliated with Guilan University of Medical Sciences, Rasht, Iran)
Excluded: married women who were at reproductive age (unless they used a reliable non‐hormonal contraception method), history of taking olanzapine in the recent 3 months, history of allergy or intolerance to olanzapine, history of significant head trauma (causing loss of consciousness > 5 min or neurological or cognitive sequels), liver and kidney impairment, symptomatic cerebrovascular or cardiovascular disease, diabetes mellitus, metabolic syndrome (based on National Heart, Lung, and Blood Institute/American Heart Association definition), cancer, use of antiepileptic, antihypertensive, anticoagulant, or antiplatelet drugs, using inhibitors or stimulants of hepatic isoenzymes that metabolise melatonin or olanzapine (e.g. omeprazole, rifampin, fluvoxamine, ciprofloxacin, carbamazepine, modafinil), delirium, need for administration of other antipsychotics, and addictive disorders
Interventions

  1. Olanzapine + melatonin (3 mg)

  2. Olanzapine + placebo


Standard care included sleep‐enhancing agents
Outcomes Able to use:

  1. Primary outcomes

    1. Weight measures

      1. Change in body weight

  2. Secondary outcomes

    1. Weight measures

      1. Anthropometric measures (waist circumference, hip circumference, waist/hip ratio)

    2. Physiological: cardiovascular measures

      1. Blood pressure

    3. Physiological: laboratory measures

      1. Insulin

      2. Fasting blood glucose

      3. HOMA‐IR

      4. HDL‐cholesterol

      5. LDL‐cholesterol

      6. TGS

      7. Total cholesterol

    4. Mental state

      1. PANSS (total, positive, negative, general)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients were randomly assigned to 2 groups by blocked randomisation procedures
Allocation concealment (selection bias) Unclear risk Allocation concealment not indicated
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind (participant, caregiver, investigator, outcomes assessor)
Blinding of outcome assessment (detection bias)
All outcomes Low risk Outcome unlikely to be biased by blinding.
Incomplete outcome data (attrition bias)
All outcomes Low risk No loss to follow‐up suggested; all participants in both arms completed the study
Selective reporting (reporting bias) Low risk There is no evidence of selective reporting upon comparing clinical trial registry information with the published study.
Other bias Low risk No obvious bias