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Correlation between Long-term Heart Rate Variability and Treatment Outcomes in Adolescents with Depression Accompanied by Anxiety Features

Correlation between Long-term Heart Rate Variability and Treatment Outcomes in Adolescents with Depression Accompanied by Anxiety Features

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085168
Enrollment
Unknown
Registered
2024-05-31
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

depression

Interventions

Treatment Group:antidepressant treatment

Sponsors

Hangzhou Seventh People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for patients with Major Depressive Disorder (MDD) are as follows: 1) Age between 12 and 18 years, with no gender restrictions; 2) Diagnosed by two clinically experienced psychiatrists with the title of Deputy Chief Physician or above, through a consensus examination, based on the DSM-5 criteria for Major Depressive Disorder; 3) A score greater than 17 on the Hamilton Depression Rating Scale (HAMD-17) or a score of 40 or above on the Children's Depression Rating Scale - Revised (CDRS-R); 4) Subjects have not received antidepressant treatment in the past or have not been on antidepressant medication for at least two months prior to the study; 5) Both the subject and their family agree to participate in this study and have signed a written informed consent form. 3.1.2 Diagnostic criteria for MDD patients with anxiety and painful features: According to DSM-5, if a patient with depression exhibits at least two of the following symptoms for most of the time, they are defined as having anxiety and painful features: ? Feeling agitated or nervous; ? Feeling unusually restless; ? Difficulty concentrating due to worry; ? Fear that something terrible might happen; ? Feeling as if they might lose control of themselves. Additionally, the factor score for anxiety/somatization on the HAMD-17 should be 7 or higher. 3.1.3 Inclusion criteria for healthy control (HC) subjects are as follows: 1) Age between 12 and 18 years, with no gender restrictions; 2) No history of depressive disorder or other psychiatric disorders according to DSM-5, neither in the past nor currently, and their first-degree relatives also have no history of related psychiatric disorders.

Exclusion criteria

Exclusion criteria: 1. History of severe somatic diseases, neurological disorders, and cranial trauma. 2. Patients with mental retardation according to DSM-5, substance dependence or abuse (excluding nicotine and caffeine), obsessive-compulsive disorder, post-traumatic stress disorder, eating disorders, etc. 3. Individuals with implanted cardiac pacemakers, artificial heart valves, and other metallic implants in the body.

Design outcomes

Primary

MeasureTime frame
nocturnal ECG signal;Hamilton Rating Scale for Depression, HAMD-17;The Children’s Depression Rating Scale-Revised, CDRS-R;

Secondary

MeasureTime frame
Hamilton Rating Scale for Anxiety, HAMA;Generalized Anxiety Disorder-7, GAD-7;Pittsburgh sleep quality index, PSQI;

Countries

China

Contacts

Public ContactHaisi Chen

Hangzhou Seventh People's Hospital

834446096@qq.com+86 159 5878 7663

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026