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. 2019 Mar 19;2019(3):CD011847. doi: 10.1002/14651858.CD011847.pub2

Cai 2008.

Methods Allocation: parallel, randomised
Blind: not stated
Setting: hospital (inpatient), single centre
Country: China
Length of study: 8 weeks
Participants Diagnosis: treatment‐resistant schizophrenia (CCMD‐3)
Total N at randomisation = 100
Sex: male 57, female 43
Age (years): range 18 to 60
Length of illness (years): range 1 to 10
History: BPRS score > 50; received at least 3 types of resistance psychiatric drug therapy, of which at least 2 different classes of chemical structures; dose of each drug equivalent to chlorpromazine 600 mg/d or more, failure after more than 4 weeks of treatment, or failure after 4 weeks of treatment when receiving clozapine (≥ 450 mg/d) ('failure' was defined as the reduction rate of BPRS score ≤ 20%).
Exclusion criteria: people with severe heart, liver, kidney disease, chronic body diseases, epilepsy, alcohol or drug abusers, MECT contraindications.
Interventions ECT group (n = 50): MECT + clozapine
Content: participants who received clozapine before enrolment continued to use clozapine. Participants who received other antipsychotics before enrolment needed a 1‐week wash‐out period and then received clozapine. The initial dose of clozapine was 50 mg/d, increased to 50 to 100 mg/d alternate days. The maximum dose of clozapine was no more than 300 mg/d when combined with MECT.
Frequency: 3 times a week for MECT, not stated for clozapine
Course of treatment (MECT): 6 to 12 sessions
Treatment duration: 8 weeks
Control group (n = 50): Clozapine alone
Content: the usage and dosage of clozapine was same as above. The maximum dose ranged from 300 mg/d to 700 mg/d.
Frequency: not stated
Treatment duration: 8 weeks
Outcomes Response to treatment: clinically significant response to treatment*
Mental state: assessed by BPRS
Adverse events: assessed by TESS
Notes *Clinically significant response assessed by the reducing score rate of BPRS:
1) cure: reducing rate ≥ 75%;
2) significant improvement: reducing rate between 50% and 74%;
3) improvement: reducing rate between 25% and 49%;
4) no clinical response: reducing rate < 25%.
Clinically significant response to treatment was defined as cure + significant improvement.
Contact information: Third People's Hospital of Yuebei, Lechang, Guangdong, China
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "...were divided randomly into two groups..." (p.1423)
Comments: The author described a random component in the sequence generation process, but no details were provided on randomisation method.
Allocation concealment (selection bias) Unclear risk Comments: The author did not describe the allocation concealment. Insufficient information to permit judgement of 'low risk' or 'high risk'.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comments: Participants and personnel could not be blinded as 1 group did not use ECT, and no sham‐ECT was used.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comments: The author did not describe the blinding of outcome assessment. Insufficient information to permit judgement of 'low risk' or 'high risk'.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comments: No missing outcome data.
Selective reporting (reporting bias) Low risk Comments: The protocol is not available; all outcomes stated in methods were reported in results.
Other bias Low risk None obvious.