Status:
NOT_YET_RECRUITING
A Study on Functional Connectome and rTMS Intervention of Cognitive Flexibility Impairment in Patients With Major Depressive Disorder
Lead Sponsor:
Second Xiangya Hospital of Central South University
Conditions:
Depressive Disorder, Major
Cognitive Impairment
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Persistent cognitive impairment in major depressive disorder (MDD) affects both treatment outcomes and psychosocial functioning, emphasizing the critical need for effective treatment. However, there i...
Detailed Description
This is a mechanistic clinical trial investigating the neural basis of cognitive flexibility (CF) impairment in major depressive disorder (MDD) and the therapeutic effects of targeted neuromodulation....
Eligibility Criteria
Inclusion
- Meets DSM-5 criteria for Major Depressive Episode confirmed by two attending psychiatrists using SCID-5
- Currently in depressive episode (MADRS ≥22)
- Stable dose of SSRIs/SNRIs for ≥4 weeks prior to randomization
- Age 18-45 years
- Han Chinese ethnicity, right-handed
- Minimum junior high school education; no color blindness; capable of providing informed consent
- Willing to sign informed consent and complete all assessments
Exclusion
- Other DSM-5 psychiatric disorders (except MDD)
- Received non-pharmacotherapy in past 6 months:
- ECT
- rTMS
- Systematic psychotherapy (\>10 sessions)
- Prior CCRT treatment
- Medications affecting cognition within specified washout periods:
- Antipsychotics (1 month)
- Cholinesterase inhibitors (donepezil:14d; galantamine:2d)
- Memantine (20d)
- Nootropics (e.g., piracetam:2d)
- Significant medical comorbidities:
- Thyroid disorders, SLE, diabetes
- Hepatic/renal/pulmonary impairment
- Active infections
- Major trauma
- History of traumatic brain injury with coma
- Substance/alcohol abuse or dependence
- Active suicidal ideation/attempt (MADRS item 10 ≥4)
- Current corticosteroid therapy
- Pregnancy, lactation, or planned pregnancy
- Personal/family history of epilepsy
- Metallic implants (e.g., pacemaker, dental prostheses)
- Investigator-determined contraindications
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT07161492
Start Date
September 1 2025
End Date
October 1 2028
Last Update
September 8 2025
Active Locations (1)
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1
Xiangya Second Hospital of Central South University
Changsha, Hunan, China, 410011