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Exploring Antidepressant Intervention: A New Pathway for Elderly Patients with Idiopathic Pulmonary Fibrosis to Delay the Progression of the Disease and Combat Physical Frailty

Clinical Trial of Antidepressant Intervention for Delaying Disease Progression and Physical Frailty among Elderly Idiopathic Pulmonary Fibrosis Patients - CT - AI - DDP - PF - EIPFP

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057161
Enrollment
213
Registered
2025-02-27
Start date
2018-01-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Idiopathic pulmonary fibrosis

Interventions

This study is divided into an intervention group and a non - intervention group. Patients in the intervention group can independently choose to receive any one of the three antidepressant intervention

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) According to the ATS/ERS/JRS/ALAT clinical practice guidelines issued in 2018, all patients were diagnosed with idiopathic pulmonary fibrosis. (2) There was no previous history of any mental or psychological disorders, that is, there had never been any symptoms related to mental or psychological illnesses that lasted continuously for more than 24 hours, and there was no relevant medical treatment experience either. (3) After the diagnosis of idiopathic pulmonary fibrosis, different degrees of low mood, decreased interest, and anhedonia gradually appeared (lasting for more than two weeks), and at the time of this admission, depression was present as assessed by the Beck Depression Inventory - II.

Exclusion criteria

Exclusion criteria: (1) Other types of pulmonary fibrosis, which are not idiopathic pulmonary fibrosis. (2) There is a previous history of any mental or psychological disorder. (3) After the diagnosis of idiopathic pulmonary fibrosis, there are no obvious depressive symptoms. (4) The patient refuses to participate in this study.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the deterioration of the condition of idiopathic pulmonary fibrosis and the degree of physical frailty after 12 months of follow-up. Both at baseline and after the follow-up, the following indicators are measured: the percent predicted forced vital capacity (FVC % pred), the percent predicted diffusing capacity of the lung for carbon monoxide (DLCO % pred), the 6-minute walk test (6MWT), and the score of the Modified Medical Research Council (mMRC) Dyspnea Scale. These indicators reflect the condition of idiopathic pulmonary fibrosis. In addition, the scores of the Clinical Frailty Scale (CFS), the Total Fatigue Inventory (TFI), the St. George's Respiratory Questionnaire (SGRQ), and the King's Brief Interstitial Lung Disease (K - BILD) are also measured, which are used to assess the degree of frailty in patients. Through these indicators, the effect of the intervention on delaying the progression of idiopathic pulmonary fibrosis and physical frailty can be comprehensively evaluated.

Secondary

MeasureTime frame
The key secondary outcome measures mainly focus on assessing the status of depressive symptoms and peripheral inflammation levels, which are also measured both at baseline and after the follow-up. Specifically, they include using the score of the Beck Depression Inventory - Second Edition (BDI - II) to quantify the degree of depression in patients. This score can accurately reflect the severity of patients' depressive disorder. In addition, the levels of peripheral inflammatory factors, interleukin - 6 (IL - 6) and tumor necrosis factor - a (TNF - a), will also be measured to evaluate the inflammatory state within the patients. These indicators provide crucial data support for assessing the impact of the intervention on depression and related inflammatory responses.

Countries

Asia(except Japan)

Contacts

Public ContactHongyan Ren

Henan Provincial People's Hospital Department of Respiratory and Critical Care Medicine

renhongyan19852024@163.com0086-0371-61621210

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026