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Randomized controlled study on the clinical efficacy of antidepressant treatment for migraine patients with gastrointestinal diseases

Randomized controlled study on the clinical efficacy of antidepressant treatment for migraine patients with gastrointestinal diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076499
Enrollment
Unknown
Registered
2023-10-10
Start date
2023-10-11
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

migraine

Interventions

Test group:antidepressant treatment
control group:Symptomatic treatment

Sponsors

Beijing Jingmei Group General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 80 Years

Inclusion criteria

Inclusion criteria: Migraine Inclusion criteria: Comply with the International Headache Classification and Diagnostic Standard III Trial Edition (ICHD ?3beta Edition) updated by the International Headache Association in 2013, with a headache frequency of = 15 d/month and a duration of>3 months. At least 5 headache attacks meet the conditions of items (1) to (3): (1) The headache lasts for 4-72 hours (without treatment or treatment failure). (2) Headache has at least 2 of the following characteristics: ? Unilateral; ? Moderate to severe pain; ? Pulsatility; ? Daily activities such as walking and climbing stairs can induce or worsen, and even avoid such daily activities. (3) At least one of the following symptoms occurs during a headache attack: ? nausea and/or vomiting; ? Fear of light and/or sound. analysis Depressive state Inclusion criteria: According to the 10th edition of the International Classification of Diseases and Diseases (ICD-10), the symptomatological criteria for depression include 3 core symptoms and 7 other symptoms. Core symptoms: ? low mood; ? Loss of interest and pleasure; ? Fatigue, decreased vitality, or loss of vitality. Other symptoms: ? concentration and decreased attention; ? Self evaluation and decreased confidence; ? The concept of self guilt and a sense of worthlessness; ? Believing that the future is bleak and pessimistic; ? The idea or behavior of self injury or suicide; ? Sleep disorders; ? Loss of appetite. SAS, SDS scale scores = 50 points

Exclusion criteria

Exclusion criteria: Migraine (1) Other primary and secondary headaches; (2) Concomitant organic digestive system diseases and/or malignant tumors; (3) Bilateral emotional disorders, schizophrenia; (4) Dementia; (5) Alcohol abusers; (6) Severe internal medicine diseases; (7) Individuals with abnormal written and oral communication. Depressive state Exclusion criteria: (1) Does not meet the criteria for brain organic mental disorders, physical diseases, and mental disorders caused by psychoactive substances and non dependent substances; (2) Some schizophrenic symptoms may exist, but do not meet the diagnostic criteria for schizophrenia. If both meet the diagnostic criteria for schizophrenia, the differential diagnosis can refer to the diagnostic criteria for schizophrenic affective psychosis; (3) SAS and SDS scales with a score of 70 or above.

Design outcomes

Primary

MeasureTime frame
HIT-6;GSRS;SAS;SDS;

Countries

China

Contacts

Public ContactGuo Hui

Beijing Jingmei Group General Hospital

guohui5221@163.com+86 132 6412 5045

Outcome results

None listed

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