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The role of MTHFR gene polymorphism and DNA methylation in SSRI-resistant depression

The role of MTHFR gene polymorphism and DNA methylation in SSRI-resistant depression.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094560
Enrollment
Unknown
Registered
2024-12-24
Start date
2023-07-17
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Major depressive disorder

Interventions

SSRI treatment effective group:NA
5-Methyltetrahydrofolate Intervention Group:Supplement 5-methyltetrahydrofolate to individuals carrying the MTHFR risk allele, conduct a 6-week intervention, assess the degree of depression improvemen

Sponsors

Beijing Anding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Sample Inclusion Criteria: 1. The informed consent has been signed, and all assessments have been completed. 2. Assessed using the Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Patient Edition (SCID-I/P), meeting the DSM-IV diagnostic criteria for depression. 3. HAMD-17 score >= 17. 4. Age between 18-60 years, no gender restriction. 5. History of SSRI medication treatment. SSRI Resistance Screening Criteria: Ineffectiveness of SSRI treatment at adequate dosage and duration. Specifically: 1. Medication dosage >= fluoxetine 40mg/day or its equivalent (sertraline >= 100mg/day, paroxetine >= 30mg/day, escitalopram >= 15mg/day, citalopram >= 40mg/day). 2. Each medication used for no less than 6 weeks (>=6 weeks). 3. Criteria for poor final treatment response: HAMD-17 total score reduction rate from baseline < 25%. SSRI Treatment Efficacy Screening Criteria: Taking SSRI medication for at least 6 weeks, with a HAMD-17 total score <= 7 after treatment, is considered effective SSRI treatment.

Exclusion criteria

Exclusion criteria: 1. Comorbidity with other mental disorders. 2. History of traumatic brain injury, epilepsy, or other known organic diseases of the central nervous system. 3. Presence of, or history of, severe or unstable physical diseases. 4. Substance dependence or abuse, or mental disorders induced by psychoactive substances. 5. Pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
Changes in Peripheral Blood DNA Methylation Levels;response rate;

Secondary

MeasureTime frame
MTHFR gene polymorphism;Target gene methylation level;Difference in QIDS-SR score reduction between the two groups;

Countries

China

Contacts

Public ContactNan Lyu

Beijing Anding Hospital, Capital Medical University

lvnangirl@163.com+86 188 1179 6426

Outcome results

None listed

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