Supplemental Transcranial Magnetic Stimulation (TMS) vs. Standard Medication Monotherapy for Treating Major Depression: An Exploratory Field Study

NCT01944657 | Withdrawn

• 1 other identifier: SPHS IRB [354612-3]
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A. Introduction to the Problem This field experiment is intended to explore whether supplemental transcranial magnetic stimulation (TMS) is more effective than standard medication mono-therapy for the treatment of major depressive disorder. Transcranial magnetic stimulation (TMS) is now included in the practice guidelines of the American Psychiatric Association for the treatment of major depression. B. Importance of the Area of Study The safety, efficacy and value of TMS treatment has been established through the four-phase FDA approval process. The evidence of TMS safety and efficacy derives from multiple, peer reviewed, double-blind, randomized, control trials (RCT) with sham control as well as strict enrollment and methodological requirements. TMS is now used in actual clinical practice and there is an opportunity to extend laboratory research and typical, highly controlled field settings to applied settings. This study is designed to gather data on safety, efficacy and utility of TMS as it is used in clinical practice. C. Need for Additional Research Efficacy and safety of these interventions have been scientifically established and meta-analyses of these studies underscore the efficacy and safety of two treatment interventions to be employed in this study: 1) standard medication monotherapy and 2) standard medication therapy supplemented with TMS. However, many authors conclude that depression can be difficult to treat and there is an ongoing need for additional research. Depression remains a major public health problem.

Conditions

1. Major Depressive Disorder

Keywords

Major Depressive Disorder Clinical Outcomes; Transcranial Magnetic Stimulation; Standard Medication Monotherapy; Exploratory Field Study

Outcome Measures

Primary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  The Montgomery-Åsberg Depression Rating Scale (abbreviated MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure changes in the severity of depressive episodes in patients with mood disorders. The following items are included in the MADRS: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. Interviews can take approximately 20 to 60 minutes to complete.

  Baseline / Four Weeks / Six Weeks / Eight Weeks

Secondary Outcomes (1)

• Hamilton Rating Scale for Depression (HRSD)

  Baseline / Four Weeks / Six Weeks Weeks / Eight Weeks

Other Outcomes (3)

• Client Satisfaction Questionnaire (8 Items) CSQ8

  Baseline / Eight Weeks

• Inventory of Depressive Symptomatology (Self - Report) IDS(SR)

  Baseline / Four Weeks / Six Weeks / Eight Weeks

• Utility Questionnaire

  8 Weeks

Study Arms (2)

Standard Medication Monotherapy Group

ACTIVE COMPARATOR

A group of 15 patients will receive only standard antidepressant medication treatment.

Drug: Standard Medication Monotherapy

Supplemental TMS plus Medication Group

ACTIVE COMPARATOR

A group of 15 patients will receive supplemental transcranial magnetic stimulation (TMS) plus standard antidepressant medication.

Device: Supplemental TMS; Drug: Standard Medication Monotherapy

Interventions

Supplemental TMS DEVICE

Supplemental TMS treatments will be administered utilizing the NeuroStar TMS Therapy® Machine. Treatment will be fixed at 120% of magnetic field intensity relative to the subject's resting motor threshold at a repetition rate of ten magnetic pulses per second, with a stimulus train duration (i.e., on time) of 4 seconds and an inter train interval (i.e., off time) of 26 seconds. The left dorsolateral prefrontal cortex will be the treatment location and this site will be determined by adjusting the TMS coil 5 cm anterior to the motor threshold location along a left superior oblique plane with a rotation point at about the tip of the patient's nose. Each treatment session will last approximately 37.5 minutes administering 3,000 magnetic pulses over the course of the treatment session.

Also known as: NeuroStar TMS Therapy® Machine

Supplemental TMS plus Medication Group

Standard Medication Monotherapy DRUG

These medications could include bupropion (Wellbutrin and others), citalopram (Celexa and others), Clomipramine (Ananfranil and others), duloxetine (Cymbalta), escitalopram (Lexapro and others), fluoxetine (Prozac and others), fluvoxamine (Luvox and others), imipramine (Tofranil and others), mirtazapine (Remeron and others), nortriptylatine (Pamelor, Aventyl, and others), paroxetine (Paxil, Pexeva, and others), phenelzine (Nardil), sertraline (Zoloft and others), tranylcypromine (Parnate and others), venlafaxine (Effexor and others).

Also known as: Standard antidepressant medications.

Standard Medication Monotherapy Group; Supplemental TMS plus Medication Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Determination of treatment resistance (i.e., failed to receive benefit from one to three prior anti-depressant treatments)
• All subjects will be between the ages of 18 and 70
• All subjects will meet the DSM-IV criteria for major depressive disorder, non-psychotic, single episode or recurrent, with a duration of episode of 3 years or less at the time of enrollment in the study.

You may not qualify if:

• A history or current existence of bi-polar disorder
• A history or current existence of anxiety disorder
• A history or current existence of mania
• A history or current existence of psychosis
• A history of continuous major depressive disorder for three years
• A history or current existence of a significant medical co-morbidity
• A history or current existence of a significant mental co-morbidity
• A history of more than three standard medication trials with a less than adequate response

Sponsors & Collaborators

• Sheppard Pratt Health System: lead
• Central Michigan University: collaborator

Study Sites (1)

Sheppard Pratt Health System

Towson, Maryland, 21204, United States

Location

MeSH Terms

Conditions

Major Depressive Disorder 1

Study Officials

• Scott T Aaronson, MD

  Sheppard Pratt Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 18, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

US (1)