Clinical trial NCT03288714: Adaptive Design Study of NEST sTMS in Subjects With Major Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Depression
Depressive Disorder, Major
Depressive Episode
Major Depressive Disorder
Keywords: Transcranial Magnetic Stimulation
TMS
sTMS
Lead sponsor: Wave Neuroscience
Sponsor class: INDUSTRY
First posted: 2017-09-20
Enrollment: 121
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sham Controlled
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Incidence of Clinical Response (Reduction of At Least 50% in Baseline HAMD-17 Score) in Per-Protocol Population
timeFrame: Baseline (Day 0) to End of Weeks 1, 2, 3, 4, 5, 6
Secondary outcomes:
measure: Mean Change (SD) in HAMD-17 Scores From Baseline to End of Treatment
timeFrame: Baseline (Day 0) and End of Weeks 1, 2, 3, 4, 5, 6
measure: Mean Change (SD) in MADRS Scores From Baseline to End of Treatment in the Per-Protocol Population
timeFrame: Baseline (Day 0) and End of Weeks 1, 2, 3, 4, 5, 6
measure: 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
timeFrame: Baseline (Day 0) and End of Weeks 1, 2, 3, 4, 5, 6
measure: Mean Change (SD) in HAMD-17 Scores From Baseline to Week 6 of Open-Label Treatments
timeFrame: Baseline (sTMS Week 6/Sham Baseline) and End of Weeks 7, 8, 9, 10, 11, 12
measure: Incidence of Clinical Response (Reduction of At Least 50% in Baseline HAMD-17 Score) in Open-Label Per-Protocol Population
timeFrame: Baseline (sTMS Week 6/Sham Baseline) and End of Weeks 7, 8, 9, 10, 11, 12
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Kadima Neuropsychiatry Institute
state: California
city: Los Angeles
country: United States
facility: UCLA Westwood - Semel Institute for Neuroscience and Human Behavior
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University/Barnes Jewish Hospital
state: Missouri
city: New York
country: United States
facility: New York University
state: New York
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Brain Health Consultants
state: Texas
Study officials:
affiliation: University of California, Los Angeles
name: Andrew Leuchter, MD
role: PRINCIPAL_INVESTIGATOR
References: