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

Wave Neuroscience

Status: Completed

Conditions: Major Depressive Disorder; Depressive Disorder, Major; Depressive Episode; Depression; Depressive Disorder

Treatments: Device: Sham Stimulation; Device: Synchronized Transcranial Magnetic Stimulation (sTMS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03288714

NND-3002

Details and patient eligibility

About

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.

Full 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).

Enrollment: 121 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 2 patient groups

Active sTMS

Experimental group

Description:

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

Treatment:

Device: Synchronized Transcranial Magnetic Stimulation (sTMS)

Sham Stimulation

Sham Comparator group

Description:

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

Treatment:

Device: Sham Stimulation