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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2021
Source Wave Neuroscience
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Prospective, randomized, double-blind, sham-controlled, parallel group adaptive design study to confirm the safety and efficacy of sTMS in subject with Major Depressive Disorder (MDD) who have not responded to at least one antidepressant medication in the current episode. MDD was diagnosed according to DSM-IV criteria rendered by structured interview using the Mini International Neuropsychiatric Interview (MINI). Subjects must have discontinued any antidepressant medication a minimum of 1 week prior to initiation of treatment with the active sTMS or sham device. Following wash-out of the antidepressant medication, an additional evaluation was performed to determine whether the protocol eligibility criteria were met before randomization and treatment. Randomized subjects were treated 5 days per week for 6 weeks. Subjects who completed 6 weeks of double-blind treatment may have been eligible to receive up to 6 weeks of open-label treatment as clinically indicated during the follow-up phase of the study. Follow-up evaluation visits were conducted during those six weeks, with frequency of the visits determined by the treatment choice during that time frame (open label subjects had weekly evaluation visits for 6 weeks).


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Synchronized Transcranial Magnetic Stimulation (sTMS)
sTMS delivers brain stimulation via a continuous magnetic field created by the device and set to the individual patient's intrinsic alpha frequency (IAF).
Sham Stimulation
Sham stimulation is designed to look, sound and feel like the investigational device, but does not deliver magnetic stimulation to the brain.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Wave Neuroscience

Country where clinical trial is conducted

United States, 

Outcome

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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