N/A
Completed N=121
Adaptive Design Study of NEST sTMS in Subjects With Major Depressive Disorder
Depressive Symptoms · Depression · Depressive Disorder, Major · Depressive Episode
Source: ClinicalTrials.gov NCT03288714 ↗
Enrolled (actual)
121
Serious AEs
1.7%
Results posted
Sep 2021
Primary outcomePrimary: Incidence of Clinical Response (Reduction of At Least 50% in Baseline HAMD-17 Score) in Per-Protocol Population — 5; 2; 7; 10 Participants — p=.814
Summary
This is a double-blind, sham controlled, multi-center study to confirm the safety and efficacy of synchronized transcranial magnetic stimulation (sTMS) for the treatment of patients currently experiencing an episode of depression who have failed to respond to at least one (1) antidepressant medication. Patients will be randomly assigned to either active or sham therapy and will undergo daily treatments for a period of time. Following completion of blinded treatments, patients may be eligible for a course of open label treatments.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Clinical Response (Reduction of At Least 50% in Baseline HAMD-17 Score) in Per-Protocol Population |
5; 2; 7; 10; 9; 12 | .814 |
| SECONDARY Mean Change (SD) in HAMD-17 Scores From Baseline to End of Treatment |
22.96; 22.04; -5.30; -4.33; -6.63; -6.65 | .872 |
| SECONDARY Mean Change (SD) in MADRS Scores From Baseline to End of Treatment in the Per-Protocol Population |
31.89; 30.72; -6.02; -5.39; -7.91; -8.63 | .641 |
| SECONDARY Responder Analysis: Mean Change (SD) in HAMD-17 Scores From Baseline to End of Treatment in Per-Protocol Patients With Individual Alpha Frequency Greater Than 9.8 Hz |
23.68; 21.91; -7.05; -4.12; -8.32; -6.15 | .032 sig |
| SECONDARY Mean Change (SD) in HAMD-17 Scores From Baseline to Week 6 of Open-Label Treatments |
16.50; 16.76; -8.82; -3.98; -9.36; -3.69 | .015 sig |
| SECONDARY Incidence of Clinical Response (Reduction of At Least 50% in Baseline HAMD-17 Score) in Open-Label Per-Protocol Population |
12; 9; 17; 9; 14; 10 | .028 sig |
Eligibility Criteria
Inclusion Criteria
- Current episode of Major Depressive Disorder
- Inadequate response to at least one antidepressant medication in the current episode (Treatment Resistant Depression)
- Investigator able to identify IAF using EEG
- Willingness and ability to adhere to treatment schedule (5 treatments per week for six weeks)
Exclusion Criteria
- Unable to unwilling to give informed consent
- Diagnosed with excluded conditions or treatment histories
- Currently hospitalized due to severity of depression symptoms
- Use of prohibited medications (as defined by protocol) within specified time frame of randomization
- Use of certain cardiac devices
- Use of certain intracranial devices
- Currently pregnant or unwilling to practice acceptable means of birth control, and women who are breastfeeding
Data sourced from ClinicalTrials.gov (NCT03288714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.