Open
Actively Recruiting
Pain and Major Depressive Disorder
About
Brief Summary
This study will examine the effects of brain stimulation on pain symptoms associated with Major depressive disorder. This study will enroll 54 Subjects. Study subjects will be asked to complete surveys about their mood and well-being, 2 blood draws, 2 MRIs, 3 electroencephalograms, and receive 30 treatments of blinded transcranial magnetic stimulation. There is no control group as all subjects will receive some form of active treatment. Subjects are required to participate in 30-33 study visits and volunteer 40 hours of their time. Compensation for this study is $150 for completing all study activities.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- All Subjects must be between 18-75 years of age
- Language: Participants must speak English fluently, as demonstrated by verbal skills sufficient to answer questions at a level that assures adequate understanding of the study
- All subjects must be right-handed
- Must have confirmed diagnosis of moderate Major Depressive Disorder (single or recurrent episode), minimum score of 17 on the 17-item Hamilton Rating Scale for Depression (HAM-D17). No minimal MDD duration necessary for study participation
- Failure to respond to a minimum of 2 trials of antidepressant medication
- Failure to respond from at least two different agent classes
- Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count)
- Must have a trial of psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration*
- Must have a confirmed FM or ME/CFS diagnoses and moderate pain complaints, minimum score of 15 on the McGill Pain Questionnaire.
- Pain chronicity for at least 3 months prior to study enrollment.
- Subjects are willing and able to adhere to the treatment schedule and required study visits.
Exclusion Criteria:
- Are mentally or legally incapacitated, unable to give informed consent.
- Are pregnant.
- Have an active suicidal intent or plan.
- Have had prior Transcranial Magnetic Stimulation treatment.
- Have an infection or poor skin condition over the scalp where the device will be positioned.
- Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure.
- Psychotic depression or other acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode.
- Neurological conditions that include 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 metallic and magnetic-sensitive medical device present in the body scan, including but not limited to a cochlear implant, infusion pump, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, aneurysm clip, metal prosthesis, or metal aneurysm clips or coils, staples, or stents. (Note: Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with transcranial magnetic stimulation and MRI)
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Study Stats
Protocol No.
20-000530
Category
Mental Health
Principal Investigator
JULIANA CORLIER
Contact
Location
- UCLA Westwood