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Completed

NCT Number: NCT03288714

Adaptive Design Study of NEST sTMS in Subjects With Major Depressive Disorder

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.

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Key information

Conditions

Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder, Major Depressive Episode Major Depressive Disorder Mental Disorders Mood Disorders

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kadima Neuropsychiatry Institute, La Jolla, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 stimulation

Device

Sham stimulation is designed to look, sound and feel like the investigational device, but does not deliver magnetic stimulation to the brain.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

Wave Neuroscience

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 20, 2017
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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