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New treatment option for Major Depressive Disorder
Official title Pain and Major Depressive Disorder
ClinicalTrials.gov ID: NCT04556890
What this study is testing
- What it's testing
- This study will examine the effects of brain stimulation on pain symptoms associated with Major depressive disorder. This study will enroll 54 Subjects.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- All people 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...
- All people 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...
- Failure to respond to a minimum of 2 trials of antidepressant medication
You likely can't join if
- 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.
See the full eligibility criteria
- All people 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 people 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...
- 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.
- people are willing and able to adhere to the treatment schedule and required study visits.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.