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

Narula 2010.

Study characteristics
Methods Randomisation: randomised, no other details
Blinding: double‐blind, no other details
Duration: 12 weeks
Country: India
Participants Diagnosis: WHO ICD‐10 schizophrenia
N = 72
Age: 18‐65 years, mean: 31.1 years
Sex: male and female
Setting: inpatients or outpatients
History: drug‐naive, first‐episode schizophrenia
Excluded: history of any other neuropsychiatric illness; use of SSRIs, mood stabilisers or any other weight‐influencing drug; substance abuse diagnosis in last 3 months; significant medical disorder; pregnancy
Interventions

  1. Topiramate (started at 50 mg/d, increased and maintained at 100 mg/d after 1st week) in combination with flexible olanzapine dose (5‐20 mg/d); N = 33

  2. Placebo in combination with flexible olanzapine dose (5‐20 mg/d); N = 34
Outcomes Able to use:

  1. Primary outcome

    1. Weight measure

      1. Body weight

      2. BMI

    2. Physiological: laboratory outcome

    3. Fasting blood glucose

    4. Fasting serum lipids

    5. TGS

    6. Total cholesterol

    7. LDL‐cholesterol

    8. HDL‐cholesterol

    9. VLDL‐cholesterol

    10. Serum insulin

    11. Serum leptin

    12. HOMA‐IR

  2. Secondary outcome

    1. Mental state

      1. PANSS (total, positive, negative, general)

    2. Physiological: cardiovascular measure

      1. Systolic blood pressure

      2. Diastolic blood pressure

    3. Adverse events

      1. Increased appetite (no. of events)

      2. Somnolence (no. of events)

      3. Insomnia (no. of events)

      4. Asthenia (no. of events)

      5. Constipation (no. of events)

      6. Dry Mouth (no. of events)

      7. Dizziness (no. of events)

      8. Fatigue (no. of events)

      9. Paresthesia (no. of events)

      10. Nausea/vomiting/diarrhoea (no. of events)

      11. Concentration/attention/memory difficulty (no. of events)

      12. Psychomotor slowing (no. of events
Notes 93‐94.4% study completers
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "[Participants] were randomly assigned"
Comment: no specific method of blinding offered
Allocation concealment (selection bias) High risk No specific discussion of allocation concealment. Combined with lack of details about allocation concealment and blinding, the cumulative risk of bias is likely to be high.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No specific discussion of blinding of participants
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No specific discussion of outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Low risk No bias in attrition during study
Selective reporting (reporting bias) Low risk No protocol, however, measures are objective and therefore risk of bias low
Other bias Low risk No obvious bias