Depressive DisorderNCT03288714
Adaptive Design Study of NEST sTMS in Subjects With Major Depressive Disorder
A study testing Synchronized Transcranial Magnetic Stimulation (sTMS) in people with Depressive Disorder and Depression, run by Wave Neuroscience at 14 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Depressive Disorder, Depression, Depressive Disorder, Major
- What is being tested?
- Synchronized Transcranial Magnetic Stimulation (sTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 14 sitesUnited States
- Study dates
- 27 Nov 2017to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Emory University
Atlanta, Georgia, 30329
Sheppard Pratt Health System
Baltimore, Maryland, 21204
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Brain Health Consultants
Houston, Texas, 77046
Kadima Neuropsychiatry Institute
La Jolla, California, 92037
UCLA Westwood - Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, 90024
New York University
New York, New York, 10016
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Butler Hospital
Providence, Rhode Island, 02906
Mayo Clinic
Rochester, Minnesota, 55905
Washington University/Barnes Jewish Hospital
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
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
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.
Read the detailed 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).
- Conditions
- Depressive Disorder, Depression, Depressive Disorder, Major, Depressive Episode, Major Depressive Disorder
- Being tested
- Synchronized Transcranial Magnetic Stimulation (sTMS), Sham Stimulation
- Keywords
- Transcranial Magnetic Stimulation, TMS, sTMS
- Medical subject headings
- Depressive Disorder, Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronized Transcranial Magnetic Stimulation (sTMS)Device
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 StimulationDevice
Sham stimulation is designed to look, sound and feel like the investigational device, but does not deliver magnetic stimulation to the brain.
| Study group | Role | What they receive |
|---|---|---|
| Active sTMS | Experimental | Synchronized Transcranial Magnetic Stimulation (sTMS) treatments to be administered using an active device 5 times per week for six treatment weeks. Receives: Device: Synchronized Transcranial Magnetic Stimulation (sTMS) |
| Sham Stimulation | Sham comparator | Sham treatments to be administered using a sham device 5 times per week for six treatment weeks. Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0) to End of Weeks 1, 2, 3, 4, 5, 6
Secondary outcomes (5)
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.
Measured: Baseline (Day 0) and End of Weeks 1, 2, 3, 4, 5, 6
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.
Measured: Baseline (Day 0) and End of Weeks 1, 2, 3, 4, 5, 6
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.
Measured: Baseline (Day 0) and End of Weeks 1, 2, 3, 4, 5, 6
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.
Measured: Baseline (sTMS Week 6/Sham Baseline) and End of Weeks 7, 8, 9, 10, 11, 12
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.
Measured: Baseline (sTMS Week 6/Sham Baseline) and End of Weeks 7, 8, 9, 10, 11, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start27 Nov 2017
- Primary completion1 Mar 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sham Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wave Neuroscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Leuchter, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288714
- Sponsor's protocol ID
- NND-3002
- Status last verified
- Aug 2021
- First submitted
- 18 Sep 2017
- Last updated
- 5 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03288714
- Acronym / sponsor ID
- NND-3002
- Conditions
- Depressive Disorder, Depression, Depressive Disorder, Major, Depressive Episode, Major Depressive Disorder
- Keywords
- Transcranial Magnetic Stimulation, TMS, sTMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Wave NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 20 Sep 2017 (actual)
- Results
- Posted 5 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sham Controlled
| Arm | Type | Receives |
|---|---|---|
| Active sTMS | Experimental | Device: Synchronized Transcranial Magnetic Stimulation (sTMS)Synchronized Transcranial Magnetic Stimulation (sTMS) treatments to be administered using an active device 5 times per week for six treatment weeks. |
| Sham Stimulation | Sham comparator | Device: Sham StimulationSham treatments to be administered using a sham device 5 times per week for six treatment weeks. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Active sTMS |
| Sham StimulationSham stimulation is designed to look, sound and feel like the investigational device, but does not deliver magnetic stimulation to the brain. | Device | Sham Stimulation |
Primary outcome
Incidence of Clinical Response (Reduction of At Least 50% in Baseline HAMD-17 Score) in Per-Protocol Population
Time frame: Baseline (Day 0) to End of Weeks 1, 2, 3, 4, 5, 6
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.
5 secondary outcomes
Mean Change (SD) in HAMD-17 Scores From Baseline to End of Treatment
Time frame: Baseline (Day 0) and End of Weeks 1, 2, 3, 4, 5, 6
Mean Change (SD) in MADRS Scores From Baseline to End of Treatment in the Per-Protocol Population
Time frame: Baseline (Day 0) and End of Weeks 1, 2, 3, 4, 5, 6
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
Time frame: Baseline (Day 0) and End of Weeks 1, 2, 3, 4, 5, 6
Mean Change (SD) in HAMD-17 Scores From Baseline to Week 6 of Open-Label Treatments
Time frame: Baseline (sTMS Week 6/Sham Baseline) and End of Weeks 7, 8, 9, 10, 11, 12
Incidence of Clinical Response (Reduction of At Least 50% in Baseline HAMD-17 Score) in Open-Label Per-Protocol Population
Time frame: Baseline (sTMS Week 6/Sham Baseline) and End of Weeks 7, 8, 9, 10, 11, 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Leuchter, MD principal investigator
University of California, Los Angeles
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synchronized Transcranial Magnetic Stimulation (sTMS) in people with Depressive Disorder and Depression, run by Wave Neuroscience at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinical Response (Reduction of At Least 50% in Baseline HAMD-17 Score) in Per-Protocol Population (time frame: Baseline (Day 0) to End of Weeks 1, 2, 3, 4, 5, 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.