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. 2021 Feb 16;2021(2):CD013281. doi: 10.1002/14651858.CD013281.pub2

Saddichha 2008.

Study characteristics
Methods Study design: Randomized controlled trial
Study grouping: Parallel group
How were participants recruited: All consecutive inpatients diagnosed with first episode schizophrenia
Type of RCT: Randomized, double‐blind, controlled prospective study
Participants Baseline characteristics
Risperidone
  • Sex (N, % female, % male): female 15 (45%), male 18 (55%)

  • Age (mean, SD): 26.0 (SD 5.5) years (across all treatment group)

  • Number of participants: 33


haloperidol
  • Sex (N, % female, % male): female 15 (48%), male 16 (52%)

  • Age (mean, SD): 26.0 (SD 5.5) years (across all treatment group)

  • Number of participants: 31


olanzapine
  • Sex (N, % female, % male): female 17 (49%), male 18 (51%)

  • Age (mean, SD): 26.0 (SD 5.5) years (across all treatment group)

  • Number of participants: 35


control
  • Sex (N, % female, % male): female 21 (41%, )male 30 (59%)

  • Age (mean, SD): 27.5 (SD 5.9) years

  • Number of participants: 51


Overall
  • Gender (N, % female, % male) female 47 (47%), male 52 (53%)

  • Age (mean, SD) : 26.06 (SD 5.5) years

  • Number of participants: 150


Inclusion criteria: Consenting inpatients. Diagnosed with DSM IV schizophrenia. Controls ‐ consecutively seen accompanying persons of patients attending the institute
Exclusion criteria: Patients with other psychiatric comorbidity or history of severe physical illness. Alcohol and substance abuse or dependence. History of pre‐existing diabetes or hypertension or family history of hypertension or DM.
Pretreatment: There were no significant differences between the groups in age, gender and fasting blood sugar (FBS).However, a significant difference in 2 hour post‐prandial blood sugar (PPBS) was noted between the control group and the treatment group, which persisted only for males
Interventions Intervention characteristics
Risperidone
  • Class of drug: Second generation antipsychotic

  • Dose: 4.4 ± 1.2 mg

  • Frequency: Daily

  • Duration: 6 weeks

  • Who delivered the intervention? Not reported

  • Type of intervention: Pharmacological


Haloperidol
  • Class of drug: First generation antipsychotic

  • Dose: 13.4 ± 3.6 mg

  • Frequency: Daily

  • Duration: 6 weeks

  • Who delivered the intervention? Not reported

  • Type of intervention: Pharmacological


Olanzapine
  • Class of drug: Second generation antipsychotic

  • Dose: 16.5 ± 4.6 mg

  • Frequency: Daily

  • Duration: 6 weeks

  • Who delivered the intervention? Not reported

  • Type of intervention: Pharmacological


Control
  • Class of drug: Not mentioned/no (Healthy control)

  • Dose: Not mentioned

  • Frequency: Not mentioned

  • Duration: ‐

  • Who delivered the intervention? Not mentioned

  • Type of intervention: Not mentioned

Outcomes Fasting blood sugar
  • Outcome type: Continuous

  • Reporting: Fully reported

  • Unit of measure: mg/dl

  • Direction: Lower is better

  • Data value: Endpoint


Diabetes ‐ ADA criteria
  • Outcome type: Dichotomous

  • Reporting: Fully reported

  • Direction: Lower is better

  • Data value: Endpoint


Diabetes ‐ WHO criteria (FBS)
  • Outcome type: Continuous

  • Reporting: Fully reported

  • Scale: WHO criteria

  • Unit of measure: mg/dl

  • Direction: Lower is better

  • Data value: Endpoint


Drop‐outs
  • Outcome type: Dichotomous

  • Reporting: Fully reported

  • Direction: Lower is better

  • Data value: Endpoint

Identification Sponsorship source: Not mentioned
Country: India
Setting: Central Institute of Psychiatry, Ranchi, India which is a referral psychiatric institute
Comments:
Authors name: S Saddichha
Institution: National Tobacco Control Programme, WHO India, Bhubaneshwar
Email: saddichha@gmail.com
Address: 790, Govind Prasad, Mahabir Nagar Road 2, Cuttack Road, Bhubaneswar 751012, India.
Notes Dr Sharad Philip on 11/08/2019 05:47
Population
Details not given in the text of the article or tables about O, R and H groups.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "All consecutive patients with a DSM‐IV diagnosis of schizophrenia, in the Central Institute of Psychiatry, Ranchi, India". "Patients included in the study were randomized to receive risperidone, olanzapine or haloperidol. "
Judgement comment: no sequence generation was reported. It appears randomizations may have taken place between antipsychotics but not vs control arm.
Allocation concealment (selection bias) Unclear risk Judgement comment: not mentioned. Decision of O vs R vs H was in routine care.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Judgement comment: the study was double blind, however, no detailed information on how they were blinded.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "All assessments were performed by a single investigator blind to the diagnosis and medication prescribed and all investigations were carried out in the same laboratory."
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Drop‐outs unclear.
Selective reporting (reporting bias) Unclear risk No reference to protocol.
Other sources of bias Low risk No other sources of bias identified.