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Efficacy of intermittent theta burst stimulation for treatment resistant late-life depression: a prospective randomized controlled trial

Efficacy of intermittent theta burst stimulation for treatment resistant late-life depression: a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108167
Enrollment
Unknown
Registered
2025-08-26
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

treatment resistant late-life depression

Interventions

Sponsors

Capital Medical University Affiliated Beijing Anding Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Initial onset age of 60 years or older; 2. Meeting the diagnostic criteria for depressive disorders as outlined in the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5); 3. A total score of 17 or higher on the Hamilton Depression Rating Scale-17 (HAMD-17); 4. Inadequate response to two or more antidepressants with different mechanisms of action, administered at adequate doses and durations (dose should be at least three times the minimum effective dose or two-thirds of the maximum effective dose; duration should be a minimum of three months of full treatment after reaching the threshold dose), with a reduction rate of HAMD less than 50%; 5. Educational attainment of at least primary school level, capable of cooperating to complete assessment examinations; 6. A score of less than 26 on the Montreal Cognitive Assessment (MOCA); 7. Written informed consent obtained from the individual or their family.

Exclusion criteria

Exclusion criteria: 1. History of cranial diseases, brain injury, epileptic seizures, or other neurological disorders; 2. Presence of severe or unstable cardiovascular, respiratory, immune, or other systemic diseases; 3. Previous or current diagnosis of the following psychiatric conditions according to DSM-5: organic mental disorders, Alzheimer's disease, secondary dementia due to other causes, schizophrenia, schizoaffective disorder, bipolar affective disorder, delusional disorder, unspecified mental illness, alcohol (or drug) dependence or abuse, personality disorders; 4. Contraindications for magnetic resonance imaging or transcranial magnetic therapy, such as the presence of electronic or metal implants (dentures, arterial clips, pacemakers, or metal fixations), claustrophobia, etc.; 5. Participation in an interventional clinical trial within the three months prior to screening; 6. Pregnant, lactating women, or those planning to become pregnant.

Design outcomes

Primary

MeasureTime frame
Depressive symptom ;

Secondary

MeasureTime frame
cognitive function;

Countries

China

Contacts

Public ContactRen Li

Capital Medical University Affiliated Beijing Anding Hospital

18618180828@163.com+86 186 1818 0828

Outcome results

None listed

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