Depression Clinical Trial
Official title:
A Prospective, Multicenter, Double-Blind, Sham-Controlled Adaptive Design Study to Confirm the Safety and Efficacy of NEST sTMS in Subjects With Major Depressive Disorder Who Have Not Responded to at Least One Antidepressant Medication in the Current Episode
NCT number | NCT03288714 |
Other study ID # | NND-3002 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 27, 2017 |
Est. completion date | June 1, 2019 |
Verified date | August 2021 |
Source | Wave Neuroscience |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 121 |
Est. completion date | June 1, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | Sheppard Pratt Health System | Baltimore | Maryland |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Brain Health Consultants | Houston | Texas |
United States | Kadima Neuropsychiatry Institute | La Jolla | California |
United States | UCLA Westwood - Semel Institute for Neuroscience and Human Behavior | Los Angeles | California |
United States | New York University | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Butler Hospital | Providence | Rhode Island |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Washington University/Barnes Jewish Hospital | Saint Louis | Missouri |
United States | Stanford University | Stanford | California |
United States | Laureate Institute for Brain Research | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Wave Neuroscience |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Clinical Response (Reduction of At Least 50% in Baseline HAMD-17 Score) in Per-Protocol Population | Number of participants at the end of each treatment week who saw a reduction of at least 50% in baseline Hamilton Depression Rating Scale (HAMD-17) scores from baseline to week 6, compared between the active treatment and sham-controlled groups.
The Hamilton Depression Rating Scale (HAMD-17) system asks 17 questions to rank subject on a scale ranges between 0-52, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in remission), while a score of 20 or higher indicates moderate to severe depression. |
Baseline (Day 0) to End of Weeks 1, 2, 3, 4, 5, 6 | |
Secondary | Mean Change (SD) in HAMD-17 Scores From Baseline to End of Treatment | Change from the baseline in HAMD-17 total score from baseline to week 6, compared between the active treatment and sham-controlled groups.
The Hamilton Depression Rating Scale (HAMD-17) system asks 17 questions to rank subject on a scale ranges between 0-52, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in remission), while a score of 20 or higher indicates moderate to severe depression. |
Baseline (Day 0) and End of Weeks 1, 2, 3, 4, 5, 6 | |
Secondary | Mean Change (SD) in MADRS Scores From Baseline to End of Treatment in the Per-Protocol Population | Change from the baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to week 6, compared between the active treatment and sham-controlled groups.
The MADRS scale ranges between 0-54, with higher numbers indicating more severe symptoms. 0-6 is generally accepted to be within the normal range (or in remission), 7-19 represents mild depression, while a score of 20 or higher indicates moderate to severe depression. |
Baseline (Day 0) and End of Weeks 1, 2, 3, 4, 5, 6 | |
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 | Measure of change in mean (SD) of HAMD-17 scores from baseline to end of treatment in per-protocol patients with an Individual alpha frequency (IAF) of greater than 9.8Hz.
The Hamilton Depression Rating Scale (HAMD-17) system asks 17 questions to rank subject on a scale ranges between 0-52, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in remission), while a score of 20 or higher indicates moderate to severe depression. |
Baseline (Day 0) and End of Weeks 1, 2, 3, 4, 5, 6 | |
Secondary | Mean Change (SD) in HAMD-17 Scores From Baseline to Week 6 of Open-Label Treatments | Change in HAMD-17 total score during 6 weeks of open-label treatment, compared between the active treatment and sham-controlled groups.
The Hamilton Depression Rating Scale (HAMD-17) system asks 17 questions to rank subject on a scale ranges between 0-52, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in remission), while a score of 20 or higher indicates moderate to severe depression. |
Baseline (sTMS Week 6/Sham Baseline) and End of Weeks 7, 8, 9, 10, 11, 12 | |
Secondary | Incidence of Clinical Response (Reduction of At Least 50% in Baseline HAMD-17 Score) in Open-Label Per-Protocol Population | Number of participants seeing reduction of at least 50% in baseline Hamilton Depression Rating Scale (HAMD-17) scores during 6 weeks of open-label treatment, compared between the active treatment and sham-controlled groups.
The Hamilton Depression Rating Scale (HAMD-17) system asks 17 questions to rank subject on a scale ranges between 0-52, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in remission), while a score of 20 or higher indicates moderate to severe depression. |
Baseline (sTMS Week 6/Sham Baseline) and End of Weeks 7, 8, 9, 10, 11, 12 |
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