Biomarkers of Depression and Treatment Response
ConditionDepressive Disorder, Major
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of California, San Francisco
About this trial
This study is a stratified, parallel-group, single-center study utilizing multimodal imaging techniques to identify biomarkers for Major Depressive Disorder (MDD). The study goal is to identify biomarkers for MDD and treatment response that can be implemented in clinical diagnosis and care as valid and reliable measures, through monitoring neurophysiological and electrophysiological changes across the course of transcranial magnetic stimulation (TMS) treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-70
Meet Diagnostic and Statistical Manual-V (DSM-V) diagnostic criteria for Major Depressive Disorder in a current major depressive episode, without psychotic features.
Has Montgomery-Asberg Depressive Rating Scale (MADRS) of > 19 at baseline, corresponding with moderate to severe depression.
Demonstrate a moderate level of resistance to antidepressant treatment in the current episode, defined as a failure of 1-4 adequate medication trials.
Disqualifiers
Diagnosed with acute or chronic psychotic symptoms of disorders (e.g. schizophrenia, schizophreniform, schizoaffective disorder) in the current depressive episode.
Has neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system.
Presence of an implanted magnetic-sensitive medical device in or near the head, including but not limited to pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents.
Generalized anxiety disorder as the primary DSM-V disorder during the current MDD episode.
Trial design
Design model
Parallel
Treatments tested in this trial
rTMS therapy
DevicerTMS treatment parameters will be determined by TMS care providers. Typical TMS settings for MDD involve rTMS applied at 10 Hz with an intensity of 120 % of resting motor threshold. Forty trains of 4 s duration with 11s of trains is typically applied (3000 pulses per day), resulting in approximately 90,000 pulses in a given treatment course.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Morning rTMS treatmentExperimental treatment 1 intervention
Group B: Afternoon rTMS treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in MADRS score from baseline to end of treatment
Effect size of active stimulation (mean difference in Montgomery Asberg Depression Rating Scale (MADRS) score) before and after morning and afternoon treatment course. Higher MADRS score indicates more severe depression; the overall score ranges from 0 to 60.
Time frame
Up to one month prior to initial TMS session (baseline) to within one month following the completion of TMS treatment (~ 8 weeks)2
Change in resting state BOLD signal from baseline to end of treatment
Change in resting state functional magnetic resonance imaging BOLD signal before and after the active treatment period.
Time frame
Up to one month prior to initial TMS session (baseline) to within one month following the completion of TMS treatment (~ 8 weeks)3
Change in resting state EEG from baseline to end of treatment
Change in resting state EEG (electroencephalogram) alpha band coherence before and after the active treatment period.
Time frame
Up to one month prior to initial TMS session (baseline) to within one month following the completion of TMS treatment (~ 8 weeks)4
Change in white matter integrity from baseline to end of treatment
Change in white matter integrity as measured by diffusion tensor imaging (DTI) before and after the active treatment period.
Time frame
Up to one month prior to initial TMS session (baseline) to within one month following the completion of TMS treatment (~ 8 weeks)Secondary outcomes
1
Change in Beck's Depression Inventory (BDI) score from baseline to end of treatment
The difference in Beck's Depression Inventory (BDI) score after TMS treatment course.Higher BDI score indicates more severe depression; the overall score ranges from 0 to 63.
Time frame
Up to one month prior to initial TMS session (baseline) to within one month following the completion of TMS treatment (~ 8 weeks)2
Change in Patient Health Questionnaire (PHQ9) score from baseline to end of treatment
The difference in Patient Health Questionnaire (PHQ9) score after TMS treatment course. Higher PHQ9 score indicates more severe depression; the overall score ranges from 0 to 27.
Time frame
Up to one month prior to initial TMS session (baseline) to within one month following the completion of TMS treatment (~ 8 weeks)3
Change in Generalized Anxiety Disorder (GAD-7) score from baseline to end of treatment
The difference in Generalized Anxiety Disorder (GAD-7) score after TMS treatment course. Higher GAD7 score indicates more severe depression; the overall score ranges from 0 to 21.
Time frame
Up to one month prior to initial TMS session (baseline) to within one month following the completion of TMS treatment (~ 8 weeks)4
Change in Inventory of Depressive Symptomatology (IDS-30 self report) score from baseline to end of treatment.
The difference in Inventory of Depressive Symptomatology Self-Report (IDS-SR) score after TMS treatment course. Higher IDS score indicates more severe depression; the overall score ranges from 0 to 84.
Time frame
Up to one month prior to initial TMS session (baseline) to within one month following the completion of TMS treatment (~ 8 weeks)Sponsors and contacts
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Source ClinicalTrials.gov