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

Chen 2017.

Study characteristics
Methods Study design: Randomized controlled trial
Study grouping: Parallel group
How were participants recruited: In this study, randomized grouping was used with admission time as the compatibility factor, and every fourth patient (as determined by time of admission) were set as an interval for randomized grouping. As a result, 38 cases of elderly patients with first‐episode schizophrenia was randomly divided into the ziprasidone treatment group (study group) and olanzapine treatment group (control group), with 19 cases in each group.
Type of RCT: Single blind (patient blind) parallel controlled trial design
Participants Baseline characteristics
Ziprasidone (treatment)
  • Sex (N, % female, % male): female 9 (47%), male 10 (53% )

  • Age (range and mean): 60 to 78 years, mean 68.9 years

  • Number of participants: 19


Olanzapine (control)
  • Sex (N, % female, % male): female 8 (42%), male 11 (58% )

  • Age (range and mean): 60 to 78, mean 68.2 years

  • Number of participants: 19


Overall
  • Sex (N, % female, % male): female 17 (45%), male 21 (55% )

  • Age (range and mean): 60 to 78 years, mean 68.5 years

  • Number of participants: 38


Inclusion criteria: Age ≥ 60 years old, 2) met the diagnostic criteria for schizophrenia according to the ICD‐10 classification of mental and behavioral disorders,with a PANSS total score≥60 points, 3) no issues taking ziprasidone or olanzapine, and 4) informed consent was provided by patients’ legal guardians
Exclusion criteria: 1) having diabetes mellitus, hyperlipidaemia, or severe liver and renal insufficiency, 2) presence of organic neurological disease such as epilepsy, intracranial infection, brain tumour as determined by MRI or EEG examination, 3) presence of systemic diseases such as systemic lupus erythematosus (SLE), and schizophrenia‐like behavior caused by drug intoxication
Pretreatment: No significant statistical difference between two groups
Interventions Intervention characteristics
Ziprasidone (treatment)
  • Class of drug: Ziprasidone Hydrochloride Capsules (20mg per capsule, Jiangsu Nhwa Pharmaceutical Co. Ltd.),

  • Dose: with an initial dose of 40mg/day (dose ranging from 40 to 120mg/day, and a mean (SD) dose of 92.4 (4.5) mg/day).

  • Frequency: Daily

  • Duration: 12weeks

  • Who delivered the intervention? The authors (Jing Chen, Xingen Pan, Mincai Qian, and Shoukai Yang) were responsible for the management and treatment of patients. The first author is an attending doctor of the hospital where the study took place.

  • Type of intervention: Pharmacological


Olanzapine (control)
  • Class of drug: Olanzapine tablets (5mg/tablet, Jiangsu Hansoh Pharmaceutical Group. Co. Ltd.,),

  • Dose: With an initial dose of 5mg/day (dose ranging 5 to 20mg/day and a mean (SD) of 9.5 (4.3)mg/day).

  • Frequency: Daily

  • Duration: 12 weeks

  • Who delivered the intervention? The authors (Jing Chen, Xingen Pan, Mincai Qian, and Shoukai Yang) were responsible for the management and treatment of patients. The first author is an attending doctor of the hospital where the study took place.

  • Type of intervention: Pharmacological

Outcomes Fasting blood sugar
  • Outcome type: Continuous

  • Unit of measure: mmol/L

  • Direction: Lower is better

  • Data value: Endpoint


Cholesterol
  • Outcome type: Continuous

  • Unit of measure: mmol/L

  • Direction: Lower is better

  • Data value: Endpoint

Identification Sponsorship source: Zhejiang Province Huzhou 3rd People’s Hospital Public Welfare Application Research project (project # 2016GYB03)
Country: China
Setting: The Third People’s Hospital of Huzhou, Huzhou, Zhejiang Province, China
Comments:
Authors name: Jing Chen, Xingen Pan, Mincai Qian, and Shoukai Yang
Institution: Department of Geriatric Psychiatry, The Third People’s Hospital of Huzhou
Email: E‐Mail: 781703956@qq.com
Address: Department of Geriatric Psychiatry, The Third People’s Hospital of Huzhou, Huzhou,Zhejiang Province, China. Postcode: 313000.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomized grouping was used with admission time as the compatibility factor, and every fourth patient (as determined by time of admission) were set as an interval for randomized grouping".
Allocation concealment (selection bias) Unclear risk Paper did not mention who randomized the patients into two groups and how the allocation was determined.
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "Single blind (patient blind) parallel controlled trial design was used". Participants were blinded but insufficient information to determine how blinding was tested, guaranteed or maintained.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk The paper did not mention who participated in the outcome measurement.
Incomplete outcome data (attrition bias)
All outcomes Low risk Authors report no drop‐out; data available for all participants.
Selective reporting (reporting bias) Unclear risk No reference to protocol.
Other sources of bias Low risk No further sources of bias identified.