Clinical trial for Major Depressive Disorder
Official title Cortical rTMS as a Treatment for Depression
ClinicalTrials.gov ID: NCT05487911
What this study is testing
- What it's testing
- The study wants to see if stimulating the orbitofrontal cortex can lower depressive symptoms.
- Who it's for
- Adults who have major depressive disorder, including those with opioid use disorder or suicidality.
- What's involved
- Participants will receive repeated sessions of non‑invasive magnetic brain stimulation and will complete study visits and questionnaires.
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 64
You may be able to join if
- Be male or female aged 18-64 years old.
- Has depressive symptoms according to the PHQ-9 or MADRS or HDRS or SHAPS
- Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
- Female people must be non-nursing and not pregnant at the times of fMRI experiments and TMS treatment
- Has no contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.)
You likely can't join if
- In the opinion of the clinician and/or the research team, be expected to fail to complete the study protocol due to not tolerable to receive TMS
- Unable to understand the design and requirements of the study;
- Unable to sign informed consent for any reason
- Has an unstable medical condition, including AIDS, acute hepatitis, active TB, unstable cardiac disease, unstable diabetes, hepatic or renal...
- Female people who are pregnant or nursing
- Contraindications to MRI (pacemaker, cochlear implants, metal in the eye, other metal implants, etc.): Do not meet the pre-screening MRI questions...
See the full eligibility criteria
- Be male or female aged 18-64 years old.
- Has depressive symptoms according to the PHQ-9 or MADRS or HDRS or SHAPS
- Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
- Female people must be non-nursing and not pregnant at the times of fMRI experiments and TMS treatment
- Has no contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.); Meets the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI)
- Has no contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the coil, etc.)
- stabilized with medication treatments (e.g., methadone or buprenorphine) or abstinent from opioids if patients are seeking transition to naltrexone
- urine toxicity test is negative for specific drugs (e.g., opioids)
- In the opinion of the clinician and/or the research team, be expected to fail to complete the study protocol due to not tolerable to receive TMS
- Unable to understand the design and requirements of the study;
- Unable to sign informed consent for any reason
- Has an unstable medical condition, including AIDS, acute hepatitis, active TB, unstable cardiac disease, unstable diabetes, hepatic or renal insufficiency
- Female people who are pregnant or nursing
- Contraindications to MRI (pacemaker, cochlear implants, metal in the eye, other metal implants, etc.): Do not meet the pre-screening MRI questions provided by the CAMRI at BCM
- Contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the coil, etc.): Do not meet the pre-screening TMS safety questionnaire (TASS).
- Non-English speaking people (we do not have the staff and/or resources to include other languages);
- Unstable with medication treatments (e.g., methadone or buprenorphine)
- urine toxicity test is positive for specific drugs (e.g., opioids)
- currently on seizure medications (e.g., Depakote)
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.