NCT06145594Active, not recruiting
EMA-Guided Maintenance TMS for Depression
Ecological Momentary Assessment-Guided Transcranial Magnetic Stimulation Maintenance Therapy for Prevention of Depression Relapse or Recurrence
Source: ClinicalTrials.gov · Last updated 4 Dec 2024
Brief summary (registry, in English)
The goal of this study is to evaluate the use of ecological-momentary-assessment (EMA) as a method for scheduling maintenance treatments for patients with Major Depressive Disorder (MDD) who responded to an initial acute course of Transcranial Magnetic Stimulation (TMS). To assess symptom re-emergence and severity over time, the Patient Health Questionnaire-9 item (PHQ-9) will be administered weekly via a prompt with a link send to a participants' smart phones. Adaptive algorithm software will monitor each participant's PHQ-9 scores over time and determine when a threshold increase in symptoms has occured and maintenance TMS sessions should be offered. Participants in this study will be randomized to either receive weekly EMA (monitoring only) or weekly EMA with maintenance TMS sessions (scheduled as indicated by the EMA algorithm). Participation for each subject will last for one year, with maintenance TMS offered as an adjunct to ongoing treatment as usual (TAU) for depression, i.e., ongoing pharmacotherapy, psychotherapy.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 17 Nov 2023
- Start date
- 25 Sept 2023
- Primary completion date
- 25 Sept 2025
- Lead sponsor
- Butler Hospital
- Diseases
- Depression
- NCT number
- NCT06145594
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 25 Sept 2023 to the primary completion date, 25 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- •Per physician judgement: Meets standard clinical exclusion criteria for TMS based on safety, e.g., seizure disorder, significant brain injury/intracranial mass, implanted ferromagnetic metal within 30mm of the TMS coil, etc.
Who the study is looking for
- Patients with primary Major Depressive Disorder who responded (50% drop in score from pre-treatment baseline to final score on depression scale) to a standard acute course of TMS Therapy at Butler Hospital.
- PHQ-9 \<10
- Must have access to smart phone and ability to use electronic device
- Continues to meet standard eligibility criteria for clinical TMS procedures and have been medically cleared to receive treatments, per physician judgement.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Butler Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.