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Study protocol for a parallel-group, double-blinded, randomized, controlled, noninferiority trial: the effect and safety of hybrid electroconvulsive therapy (Hybrid-ECT) compared with routine electroconvulsive therapy in patients with depression

Study protocol for a parallel-group, double-blinded, randomized, controlled, noninferiority trial: the effect and safety of hybrid electroconvulsive therapy (Hybrid-ECT) compared with routine electroconvulsive therapy in patients with depression

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022905
Enrollment
Unknown
Registered
2019-05-01
Start date
2019-05-05
Completion date
Unknown
Last updated
2019-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

Experimental group:msECT

Sponsors

Shenzhen Kangning Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Patient (18 21; 4) Patient was competent to provide informed consent; and 5) Patient was sufficiently fluent in Chinese to ensure valid responses to the neuropsychological tests.

Exclusion criteria

Exclusion criteria: 1) Failure to respond to earlier ECT; 2) ECT within the last six months; 3) Rapid-cycling or mixed-episode bipolar disorder; 4) Medication use incompatible with ECT treatment (such as lithium, benzodiazepine, antiepileptic drugs, etc.). Use of these drugs will be stopped at least 5 half-lives before the start of treatment; 5) Inability to follow the study protocol; 6) Unstable, serious comorbid medical condition (Parkinson’s disease, multiple sclerosis, stroke, alcohol use disorder, etc.) or history of epilepsy; 7) Intelligence quotient (IQ) = 70 tested by the Wechsler Adult Intelligence Scale 4th edition ; 8) = 9 years of education; 9) Pregnancy or women without adequate contraception; 10) Young Mania Rating Scale (YMRS) score [25] > 20.

Design outcomes

Primary

MeasureTime frame
HAMD-24 score;

Secondary

MeasureTime frame
PANSS;cognitive function;social function;

Countries

China

Contacts

Public ContactXin-hui Xie, Ying-jia Yang

Shenzhen Kangning Hospital

xin-hui.xie@live.com+86 18575561317

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 1, 2026