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Validation and Mechanism Study of CACNA1A Gene as a Biomarker for Antidepressant Efficacy

Validation and Mechanism Study of CACNA1A Gene as a Biomarker for Antidepressant Efficacy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129527
Enrollment
Unknown
Registered
2026-08-06
Start date
2026-07-18
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Major depressive disorder

Interventions

Duloxetine group:Receive monotherapy with the antidepressant duloxetine for 8 weeks
Venlafaxine group:Receive monotherapy with the antidepressant venlafaxine for 8 weeks
Fluoxetine group:Receive monotherapy with the antidepressant fluoxetine for 8 weeks

Sponsors

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Diagnostic criteria: Meet the diagnostic criteria for "Major Depressive Disorder (MDD)" as outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 2.The precise definition of "first episode": the first occurrence of a depressive episode, with the current episode lasting >= 2 weeks and 1 month is required; 4.Age and gender: aged 18-60 years (to avoid heterogeneity in geriatric depression); no gender restrictions; 5.Severity of illness: Hamilton Depression Rating Scale (HAMD-17) score >= 17 (moderate or above); 6.Physical condition: Generally in good health, with no severe heart, liver, kidney, or neurological disorders—including uncontrolled hypertension, diabetes, coronary artery disease, epilepsy, Parkinson’s disease, active infections or chronic inflammatory conditions (CRP > 10 mg/L), history of malignant tumors, autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus), or alcohol dependence. 7.Laboratory tests: No significant abnormalities were found in the complete blood count, liver and kidney function tests, or electrocardiogram (ECG). 8.Capacity for Informed Consent: Possess full civil capacity, able to understand the research content and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Diagnosis excluded: severe suicide risk, substance dependence, schizophrenia, dementia or mental retardation, obsessive-compulsive disorder, post-traumatic stress disorder (PTSD), etc. 2.Have previously received electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS), or have undergone systematic psychotherapy (at least once per week for at least 4 weeks) within the past 3 months. 3.Special populations: Women who are pregnant, breastfeeding, or planning to become pregnant within the next year; individuals with allergies (history of hypersensitivity to SSRIs).

Design outcomes

Primary

MeasureTime frame
17-item Hamilton Depression Rating Scale (HAMD-17) scores;RNA value of the CACNA1A gene;

Secondary

MeasureTime frame
17-item Hamilton Depression Rating Scale (HAMD-17);Treatment Emergent Symptom Scale (TESS) scores;Sheehan Disability Scale(SDS);

Countries

China

Contacts

Public ContactYang Jianzhong

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

jzhyang2004@163.com+86 571 87236114

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026