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

NCT ID: NCT03288714

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-27
• Study Completion Date: 2019-06-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active sTMS

Synchronized Transcranial Magnetic Stimulation (sTMS) treatments to be administered using an active device 5 times per week for six treatment weeks.

Group Type: EXPERIMENTAL

Synchronized Transcranial Magnetic Stimulation (sTMS)

Intervention Type: 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

Sham treatments to be administered using a sham device 5 times per week for six treatment weeks.

Group Type: SHAM_COMPARATOR

Sham Stimulation

Intervention Type: DEVICE

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

Interventions

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).

Intervention Type: DEVICE

Sham Stimulation

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wave Neuroscience

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Leuchter, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Kadima Neuropsychiatry Institute

La Jolla, California, United States

UCLA Westwood - Semel Institute for Neuroscience and Human Behavior

Los Angeles, California, United States

Stanford University

Stanford, California, 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

Mayo Clinic

Rochester, Minnesota, United States

Washington University/Barnes Jewish Hospital

St Louis, Missouri, United States

New York University

New York, New York, United States

Laureate Institute for Brain Research

Tulsa, Oklahoma, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Butler Hospital

Providence, Rhode Island, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Brain Health Consultants

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NND-3002

Identifier Type: -

Identifier Source: org_study_id