Clinical trial NCT04575285: Using EEG to Predict Depression Treatment Response to rTMS in Patients With Major Depression
Official title: Using EEG to Predict Depression Treatment Response to Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Major Depression
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Major Depression
Repetitive Transcranial Magnetic Stimulation
Keywords: rTMS
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
Collaborators: name: Florida International University
First posted: 2020-10-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will be treated for major depression using rTMS (according to standard care)

Brief summary: Repetitive Transcranial Magnetic Stimulation (rTMS) is a promising, novel, non-invasive therapy for depression. The study is looking at changes in specific electroencephalogram parameters in depressed patients treated with rTMS can serve as predictors of depression treatment response among cancer patents undergoing rTMS treatment of depression.

Detailed description: The study will be a prospective, single arm trial in which a set of patients who will be treated for major depression using Repetitive Transcranial Magnetic Stimulation (according to FDA approved rTMS standard care practices) also will undergo EEG recording before Repetitive Transcranial Magnetic Stimulation treatment begins, and at the completion of treatment. The Hamilton Depression Rating Scale will be given to participants by the neuropsychiatrist at baseline and weekly intervals till the completion of treatment.

The neuropsychiatrist investigators expect to see about 12 patients per year who meet treatment criteria for Repetitive Transcranial Magnetic Stimulation. Therefore, it is expected to recruit 24 subjects into the research study over a two-year period.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with cancer
* Comorbid diagnosis of major depressive disorder
* Age ≥ 18 years
* Baseline Hamilton Depression Rating Scale (HDRS) score ≥ 18
* Failed one or more adequate antidepressant trials (including selective serotonin reuptake inhibitors or SSRIs, selective norepinephrine reuptake inhibitors or SNRIs, tricyclic antidepressants or TCAs). A failed treatment response may be due to lack of antidepressant efficacy or intolerable side effects.

Exclusion Criteria:

* History of seizure or epilepsy
* History of concussion
* History of bipolar disorder
* Comorbid psychotic disorder
* Primary brain tumor or metastasis to brain
* Active comorbid substance use disorder
* History or current diagnosis of dementia
* Current pregnancy
* Unable to attend regular treatment sessions
* Any other condition in which a physician investigator feels may subject the participant to undue risk

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale score
timeFrame: baseline, and weekly until study completion, which can be up to 6 weeks
Secondary outcomes:
measure: Electroencephalograph (EEG) scalp signal changes over time
timeFrame: baseline, end of treatment, which can be up to 6 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Starlie C Belnap
state: Florida
Study officials:
affiliation: Miami Cancer Institute (MCI) at Baptist Health, Inc.
name: Geetha Nampiaparampil, MD
role: PRINCIPAL_INVESTIGATOR
References: