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The effect and safety of hybrid electroconvulsive therapy (Hybrid-ECT) compared with routine electroconvulsive therapy in patients with major depression disorder: a parallel-group, double-blinded, randomized, controlled, noninferiority pilot trial

The effect and safety of hybrid electroconvulsive therapy (Hybrid-ECT) compared with routine electroconvulsive therapy in patients with major depression disorder: a parallel-group, double-blinded, randomized, controlled, noninferiority pilot trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027701
Enrollment
Unknown
Registered
2019-11-24
Start date
2019-11-28
Completion date
Unknown
Last updated
2020-06-08

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

Conditions

major depressive disorder

Interventions

Experimental group:Hybrid-ECT

Sponsors

Second People's Hospital of Huizhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patient aged 18 to 60 years; 2. Patient met the following ICD-10 criteria and had an ECT indicationdepression (F32.2 major depressive episodes without psychotic symptoms; F32.3 major depressive episodes with psychotic symptoms); 3. Patient had an HAMD-24 score 21; 4. Patient was competent to provide informed consent; 5. Patient was sufficiently fluent in Chinese to ensure valid responses to the europsychological tests.

Exclusion criteria

Exclusion criteria: 1. Failure to respond to earlier ECT; 2. ECT or rTMS within the last 6 months; 3. Major depressive episodes of bipolar disorder with/without psychotic symptoms (ICD 31.4;F31.5); 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 (Parkinsons disease, multiple sclerosis, stroke, alcohol use disorder, etc.) or history of epilepsy; 7. 20.

Design outcomes

Primary

MeasureTime frame
HAMD-24 score;

Secondary

MeasureTime frame
PANSS;cognitive function;social function;

Countries

China

Contacts

Public ContactBo-jian Tan

Second People's Hospital of Huizhou

bojiantan@outlook.com+86 13924738555

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026