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A Simon’s optimal two-stage designed single arm study of i-HECT in youth patients with depression

A Simon’s optimal two-stage designed single arm study of i-HECT in youth patients with depression

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045682
Enrollment
Unknown
Registered
2021-04-23
Start date
2021-04-26
Completion date
Unknown
Last updated
2021-12-06

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

Conditions

Depression

Interventions

Group One:Hybrid electric convulsive therapy based on individual clinical dynamic data monitoring

Sponsors

The Second People's Hospital of Huizhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 25 Years

Inclusion criteria

Inclusion criteria: 1. Aged 16-25 years; 2. Hospitalized patients diagnosed as unipolar or bipolar depression according to ICD-10, with or without psychotic symptoms; 3. Sign the informed consent form; 4. Baseline Montgomery Depression Scale (MADRS)> 22 points or associated with suicide risk.

Exclusion criteria

Exclusion criteria: 1. Be pregnant; 2. Those who have participated in other related research within 30 days before enrollment; 3. Received ECT or rTMS treatment within 6 months before enrollment; 4. The previous poor effect on ECT; 5. In the history of psychoactive substance abuse; 6. There are contraindications related to ECT; 7. There is anesthesia risk such as cardiovascular disease; 8. There is a history of epilepsy.

Design outcomes

Primary

MeasureTime frame
Response rate;

Secondary

MeasureTime frame
Depression screening scale(PHQ-9);Generalized Anxiety Disorder Scale(GAD-7);Montgomery Depression Scale(MADRS);Common Gateway Interface(CGI);

Countries

China

Contacts

Public ContactXie Xinhui

The Second People's Hospital of Huizhou

524236152@qq.com+86 752 2122522

Outcome results

None listed

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