Major Depressive DisorderNCT05487911
Cortical rTMS as a Treatment for Depression
A study testing Repetitive Transcranial Magnetic Stimulation in people with Major Depressive Disorder and Opioid Use Disorder, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Depression is a leading cause of disability worldwide with a 19% lifetime prevalence in the United States. Dysfunctional reward processing is one of the core features of depression. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Major Depressive Disorder, Opioid Use Disorder, Suicidality
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 subjects 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.); Meets the pre-screening TMS safety questionnaire (Transcranial Magnetic Stimulation Adult Safety Screen - TASS)
- 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)
Who cannot join
- 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 subjects 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
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- 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). Additional exclusion criteria for the TMS experiments are based on the recommendations described by the international consensus panel on brain stimulation
- Non-English speaking subjects (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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Menninger Clinic
Houston, Texas, 77035
Elisabeth Stevens, BS, 713-275-2896, estevens@menninger.edu
Hyuntaek Oh, PhD
About this study
Depression is a leading cause of disability worldwide with a 19% lifetime prevalence in the United States. Dysfunctional reward processing is one of the core features of depression. Common treatments of depression include psychological therapies (e.g., cognitive behavioral therapy), medication (e.g., bupropion, sertraline) and psychological therapies and medication combined, but they may not address the function of the reward circuit in depression. These treatments often o not improve depressive symptoms in patients with depression who are classified as having treatment-resistant depression, and they may be unlikely to respond to further medication trials. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation that enables us to selectively excite or inhibit neural activity. Multiple TMS pulses given consecutively are known as repetitive TMS (rTMS), and the primary clinical location for applying rTMS is the left dorsolateral prefrontal cortex (DLPFC) for treatment of depressive symptoms. Many of these studies have shown that rTMS to the DLPFC may result in decreased depressive symptoms, but is only partially effective (response and remission rates of 41.2 and 35.3%, respectively). This evidence supports the importance of evaluating the efficacy of rTMS in other brain regions, such as the orbitofrontal cortex (OFC), in the treatment of depressive symptoms rather than in the DLPFC.
Read the detailed description
The OFC is functionally connected to other cortical brain regions (e.g., prefrontal and parietal cortices) but also to subcortical areas in the dorsal striatum, a core reward circuitry region. The OFC is structurally connected to the medial forebrain bundle (MFB), deep brain stimulation (DBS) target for depression, and the OFC may in fact be the mediator of anti-depressant effect. The functional connectivity between the OFC and those subcortical brain regions also plays an important role in addiction and suicide behaviors, which are depression's most common comorbidities. Thus, it is clear that we need a better understanding of the therapeutic mechanisms using non-invasive brain stimulation (e.g., TMS) treatment to the OFC as applied to patients with depression. As such, we propose to use a combination of interleaved TMS-fMRI, a novel method to observe and characterize causal manipulations of functional neural circuits, targeting the OFC and resting state fMRI to longitudinally study depressive symptoms and depression-related symptoms (e.g., addiction, suicidal behaviors) changes in patients with depression.
- Conditions
- Major Depressive Disorder, Opioid Use Disorder, Suicidality
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Depressive Disorder, Major, Opioid-Related Disorders, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
- 4 weeks of active rTMS (total of up to 20 sessions)
- 5 sessions per day for 5 consecutive days (total of up to 25 sessions)
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Experimental | 20 sessions of rTMS Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Accelerated TMS | Experimental | 5 iTBS sessions per day for 5 consecutive days Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional connectivity of orbital frontal cortex (OFC)
Functional connectivity of OFC changes after receiving TMS treatment
Measured: 20 days or 5 days
Clinical outcomes
Clinical outcomes include depressive symptoms, craving symptoms, and suicidal behaviors
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Nov 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyuntaek Oh, PhD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487911
- Sponsor's protocol ID
- H-51886
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kessler RC, Bromet EJ. The epidemiology of depression across cultures. Annu Rev Public Health. 2013;34:119-38. doi: 10.1146/annurev-publhealth-031912-114409.
PubMed 23514317Admon R, Pizzagalli DA. Dysfunctional Reward Processing in Depression. Curr Opin Psychol. 2015 Aug 1;4:114-118. doi: 10.1016/j.copsyc.2014.12.011.
PubMed 26258159Forbes EE, Christopher May J, Siegle GJ, Ladouceur CD, Ryan ND, Carter CS, Birmaher B, Axelson DA, Dahl RE. Reward-related decision-making in pediatric major depressive disorder: an fMRI study. J Child Psychol Psychiatry. 2006 Oct;47(10):1031-40. doi: 10.1111/j.1469-7610.2006.01673.x.
PubMed 17073982Nutt DJ. Care of depressed patients with anxiety symptoms. J Clin Psychiatry. 1999;60 Suppl 17:23-7; discussion 46-8.
PubMed 10446738Horst WD, Preskorn SH. Mechanisms of action and clinical characteristics of three atypical antidepressants: venlafaxine, nefazodone, bupropion. J Affect Disord. 1998 Dec;51(3):237-54. doi: 10.1016/s0165-0327(98)00222-5.
PubMed 10333980Rush AJ, Trivedi MH, Wisniewski SR, Stewart JW, Nierenberg AA, Thase ME, Ritz L, Biggs MM, Warden D, Luther JF, Shores-Wilson K, Niederehe G, Fava M; STAR*D Study Team. Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med. 2006 Mar 23;354(12):1231-42. doi: 10.1056/NEJMoa052963.
PubMed 16554525Hallett M. Transcranial magnetic stimulation: a primer. Neuron. 2007 Jul 19;55(2):187-99. doi: 10.1016/j.neuron.2007.06.026.
PubMed 17640522