Identifying markers for depression recurrence
Vulnerability Markers for Depression: a Concurrent TMS-fNIRS Study
The Hong Kong Polytechnic University · NCT06402422
This study is trying to see if brain activity changes can help predict if people who have recovered from depression will have another episode, by looking at different groups including those who are currently depressed and healthy individuals at risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06402422 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore whether brain excitability, influenced by intermittent theta-burst stimulation (iTBS), can serve as a trait marker for predicting recurrence in individuals with remitted major depressive disorder (rMDD). The study will recruit participants from four groups: those with rMDD, currently depressed individuals, healthy controls, and healthy individuals at elevated risk for depression due to family history. By examining the relationship between prior depressive episodes, cognitive function, and brain activity changes, the research seeks to enhance understanding of depression trajectories.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 65 with a history of recurrent major depressive disorder who are currently in remission, as well as currently depressed individuals and healthy participants with a family history of depression.
Not a fit: Patients who do not have a history of depression or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction of depression recurrence, allowing for timely interventions.
How similar studies have performed: While the approach of using brain stimulation to predict depression recurrence is innovative, similar studies have shown promise in understanding depression dynamics.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * rMDD patients: (a) aged 18 to 65; (b) a clinical diagnosis of recurrent depressive disorder by an experienced psychiatrist but currently in full remission (ICD 11, 6A71.7) according to results of the Mini International Neuropsychiatric Interview (MINI) and the Patient Health Questionnaire (PHQ-9), with a score ≤ 4; (c) at least two previous MDEs within the last 10 years; (d) no or stable (≥4 weeks) psychopharmacological medication. Current MDD patients: (a) aged 18 to 65; (b) a clinical diagnosis of current unipolar depressive disorder by an experienced psychiatrist according to DSM-IV; (c) no or stable (≥4 weeks) psychopharmacological medication. HCs: (a) aged 18 to 65 and (b) healthiness based on history and psychiatric assessment. never-depressed HCs with elevated risk for MDD (HR-HCs): (a) aged 18 to 65, (b) healthiness based on history and psychiatric assessment and (c) with a family history of psychiatric illnesses. Exclusion Criteria: * rMDD patients: (a) severe internal diseases; (b) neurological disorders or a history of severe head injuries; (c) current psychiatric comorbidities, including addiction; (d) pregnancy; (e) common fNIRS and TMS exclusion criteria, such as a history of brain surgery, head injury, cardiac pacemaker, deep brain stimulation, intracranial metallic particles, history of seizures, and antiepileptics and benzodiazepines corresponding to a dose of \>1 mg lorazepam/d. MDD patients: (a) severe internal diseases; (b) neurological disorders or a history of severe head injuries; (c) Axis-I disorders and history of alcohol or substance abuse or past co-morbid axis-I disorders being the likely primary cause of the depressive syndrome within the past 6 months; (d) pregnancy; (e) common fNIRS and TMS exclusion criteria, such as a history of brain surgery, head injury, cardiac pacemaker, deep brain stimulation, intracranial metallic particles, history of seizures, and antiepileptics and benzodiazepines corresponding to a dose of \>1 mg lorazepam/d. HCs: (a) medical history of a major systemic illness or a neurological or psychiatric disorder; (b) psychiatric disorders in their first-degree relatives; (c) pregnancy; and (d) common fNIRS and TMS exclusion criteria as stated above.
Where this trial is running
Hong Kong
- The Hong Kong Polytechnic University — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Principal investigator: Georg S Kranz, PhD — The Hong Kong Polytechnic University
- Study coordinator: Georg S Kranz, PhD
- Email: georg.kranz@polyu.edu.hk
- Phone: +852 2766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Disorder Remission, Major Depressive Disorder, Healthy, Theta-burst stimulation, Concurrent TBS/fNIRS, Verbal fluency task