Synchronized Transcranial Magnetic Stimulation (sTMS) in Major Depressive Disorder

NCT01370733 | Completed Phase 3 Results

• 1 other identifier: NND3001
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 18

Brief Summary

This study is designed to evaluate the safety and efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Major Depressive Disorder. This is a multicenter study in which subjects will be randomized to receive treatment 5 days per week for 6 weeks. Subjects who complete 6 weeks of double-blind treatment may be eligible to receive up to four weeks of open label sTMS therapy or antidepressant medications during the follow-up phase of the study. Follow-up evaluation visits will be conducted during those four weeks, with the frequency of the visits determined by the treatment choice during that timeframe.

Conditions

Major Depressive Disorder

Keywords

TMS,; MDD,; Depression,; sTMS,; NEST,; NeoSync,; EEG,; synchronous,; non-invasive neuromodulation,; transcranial magnetic stimulation,; antidepressant,

Outcome Measures

Primary Outcomes (2)

• Mean HAM-D17 Total Score Change (Intent to Treat - All)

  The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. If any subject did not complete the double-blind phase in the ITT population, the assessment last observation carried forward (LOCF) was used. The single value provided in each arm reflects the change seen. For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response.

  Baseline to End of Double-Blind Treatment Period (Week 6)

• Mean HAM-D17 Total Score Change (Per Protocol - All)

  The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to the HAM-D17 total score at Week 6. The single value provided in each arm reflects the change seen. For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response.

  Baseline to End of Double-Blind Treatment Period (Week 6)

Secondary Outcomes (7)

• Mean HAM-D17 Total Score Change (Per Protocol - Non-Naive Subjects)

  Baseline to End of Double-Blind Treatment Period (Week 6)

• Number of Subjects Who Demonstrate Clinical Response at Week 6 or Early Termination (Intent to Treat)

  Baseline to End of Double-Blind Treatment Period (Week 6)

• Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - All)

  Baseline to End of Double-Blind Treatment Period (Week 6)

• Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - Non-Naive Subjects)

  Baseline to End of Double-Blind Treatment Period (Week 6)

• Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Intent to Treat)

  Baseline to End of Double-Blind Treatment Period (Week 6)

Study Arms (2)

Active sTMS

EXPERIMENTAL

Treatment with the NEST-1 Device

Device: NEST-1 (NeoSync EEG Synchronized TMS)

Sham

SHAM COMPARATOR

Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device

Device: SHAM

Interventions

NEST-1 (NeoSync EEG Synchronized TMS) DEVICE

The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.

Active sTMS

SHAM DEVICE

The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.

Sham

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will meet the DSM-IV-TR primary diagnosis of initial or recurrent Major Depressive Disorder by DSM-IV-TR criteria rendered by structured interview using the Mini International Neuropsychiatric Interview (MINI).
• HAM-D17 score \>= 17 and Item 1 score greater than or equal to 2.
• Duration of current episode \>=8 weeks. The definition of an episode is demarcated by a period of \>=2 months when the subject did not meet full criteria for the DSM-IV-TR definition of Major Depressive Episode. Maximum duration of current episode cannot exceed 2 years.
• The baseline EEG is of sufficient duration and quality that it can be processed for quantitative analysis.
• Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.

You may not qualify if:

• Subjects are unable or unwilling to give informed consent.
• Diagnosed with the following conditions (current unless otherwise stated):
• Any other current primary Axis I mood, anxiety, or psychotic disorder, including bipolar disorder.
• Depression secondary to a general medical condition, or substance-induced.
• History of substance abuse or dependence within the past 6 months (except nicotine and caffeine).
• Any bipolar disorder or psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes.
• Eating disorder (current or within the past year).
• Obsessive compulsive disorder (lifetime).
• Post-traumatic stress disorder (current or within the past year).
• ADHD (currently being treated).
• Subjects meeting criteria for Axis II cluster A or B diagnosis based upon DSM-IV TR criteria, which in the judgment of the Investigator may hinder the subjects in completing the procedures required by the study protocol.
• Subjects with a clinically defined neurological disorder including, but not limited to:
• Any condition likely to be associated with increased intracranial pressure.
• Space occupying brain lesion.
• Any history of seizure EXCEPT those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study).

Sponsors & Collaborators

• Wave Neuroscience: lead

Study Sites (18)

UCLA Depression Research & Clinic Program

Los Angeles, California, 90024, United States

Location

UCSD Medical Center

San Diego, California, 92103, United States

Location

UCLA-Harbor

Torrance, California, 90509, United States

Location

Hartford Hospital Institute of Living

Hartford, Connecticut, 06106, United States

Location

TMS Specialists Chicago

Chicago, Illinois, 60602, United States

Location

Sheppard Pratt Health System

Baltimore, Maryland, 21285, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Center for Mood Disorders and Neuromodulation Therapies, UMDNJ-SOM

Cherry Hill, New Jersey, 08003, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Duke University Brain Stimulation and Neurophysiology Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Mood Disorders Treatment Research Program University of Pittsburgh-Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Butler Hospital Mood Disorders Research Program, Brown Department of Psychiatry and Human Behavior

Providence, Rhode Island, 02906, United States

Location

MUSC Institute of Psychiatry, Brain Stimulation Lab

Charleston, South Carolina, 29425, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

R/D Clinical Research

Lake Jackson, Texas, 77566, United States

Location

Related Publications (1)

• Leuchter AF, Cook IA, Feifel D, Goethe JW, Husain M, Carpenter LL, Thase ME, Krystal AD, Philip NS, Bhati MT, Burke WJ, Howland RH, Sheline YI, Aaronson ST, Iosifescu DV, O'Reardon JP, Gilmer WS, Jain R, Burgoyne KS, Phillips B, Manberg PJ, Massaro J, Hunter AM, Lisanby SH, George MS. Efficacy and Safety of Low-field Synchronized Transcranial Magnetic Stimulation (sTMS) for Treatment of Major Depression. Brain Stimul. 2015 Jul-Aug;8(4):787-94. doi: 10.1016/j.brs.2015.05.005. Epub 2015 May 22.

  PMID: 26143022 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Andrew Leuchter, MD
• Organization: University of California Los Angeles

afl@ucla.edu

(310) 825-0207

Study Officials

• Andrew Leuchter, MD

  UCLA Depression Research & Clinic Program

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 10, 2011
• Study Start: May 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 26, 2015
• Results First Posted: July 14, 2015

Record last verified: 2015-10

Locations

US (18)