ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01944657
Recruitment Status : Withdrawn (unable to enroll subjects)
First Posted : September 18, 2013
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Central Michigan University
Information provided by (Responsible Party):
Scott T. Aaronson, M.D, Sheppard Pratt Health System

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.


Condition or disease Intervention/treatment Phase
1. Major Depressive Disorder Device: Supplemental TMS Drug: Standard Medication Monotherapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Supplemental TMS vs. Standard Medication Monotherapy for Treating Major Depression: An Exploratory Field Study
Study Start Date : September 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Medication Monotherapy Group
A group of 15 patients will receive only standard antidepressant medication treatment.
Drug: Standard Medication Monotherapy
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).
Other Name: Standard antidepressant medications.

Active Comparator: Supplemental TMS plus Medication Group
A group of 15 patients will receive supplemental transcranial magnetic stimulation (TMS) plus standard antidepressant medication.
Device: Supplemental TMS
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.
Other Name: NeuroStar TMS Therapy® Machine

Drug: Standard Medication Monotherapy
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).
Other Name: Standard antidepressant medications.




Primary Outcome Measures :
  1. Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline / Four Weeks / Six Weeks / Eight Weeks ]
    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.


Secondary Outcome Measures :
  1. Hamilton Rating Scale for Depression (HRSD) [ Time Frame: Baseline / Four Weeks / Six Weeks Weeks / Eight Weeks ]
    The Hamilton Depression Rating Scale (HDRS), is a multiple choice questionnaire that a psychiatrist can use to rate changes in the severity of a patient's major depression. The following items are included in the HAMD: Depressed Mood, Feelings of Guilt, Suicide, Insomnia Early, Insomnia Middle, Insomnia Late, Work and Activities, Retardation: Psychomotor, Agitation, Anxiety: Psychological, Anxiety: Somatic, Somatic Symptoms (Gastrointestinal), Somatic Symptoms General, Genital Symptoms, Hypochondriasis, Loss of Weight, Insight, Diurnal Variation, De-personalization and De-realization, Paranoid Symptoms, and Obsessive and Compulsive Symptoms. Administration time is about 20-30 minutes.


Other Outcome Measures:
  1. Client Satisfaction Questionnaire (8 Items) CSQ8 [ Time Frame: Baseline / Eight Weeks ]
    The CSQ 8 is the instrument that has been selected to measure changes in patient satisfaction from baseline to eight weeks (i.e., utility) in the TMS plus standard medication group and the standard medication group. According to the developers of the scale, it was created to fill a gap or need in the health and human services field for a standardized instrument, which could be used instead of ad hoc or untested satisfaction measurement instruments. They believed the health and human services field needed a general purpose, standardized measurement instrument with sound psychometrics and acceptable reliability and internal consistency. Most importantly, for this proposed dissertation study, is this instrument's strength and sensitivity to different levels of treatment quality and value expressed by respondents or study subjects

  2. Inventory of Depressive Symptomatology (Self - Report) IDS(SR) [ Time Frame: Baseline / Four Weeks / Six Weeks / Eight Weeks ]
    The Inventory of Depressive Symptomatology (Self - Report) is an assessment tool that can be used to screen or assess changes in the severity of depression and is widely used in large national and international studies and clinical trials.

  3. Utility Questionnaire [ Time Frame: 8 Weeks ]
    Self - administered, ad hoc questionnaire comprised of 11 items intended to gauge the subject's perception of the worth or utility of treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Determination of treatment resistance (i.e., failed to receive benefit from one to three prior anti-depressant treatments)
  2. All subjects will be between the ages of 18 and 70
  3. 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.

Exclusion Criteria:

  1. A history or current existence of bi-polar disorder
  2. A history or current existence of anxiety disorder
  3. A history or current existence of mania
  4. A history or current existence of psychosis
  5. A history of continuous major depressive disorder for three years
  6. A history or current existence of a significant medical co-morbidity
  7. A history or current existence of a significant mental co-morbidity
  8. A history of more than three standard medication trials with a less than adequate response

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944657


Locations
United States, Maryland
Sheppard Pratt Health System
Towson, Maryland, United States, 21204
Sponsors and Collaborators
Sheppard Pratt Health System
Central Michigan University
Investigators
Principal Investigator: Scott T Aaronson, MD Sheppard Pratt Health System

Responsible Party: Scott T. Aaronson, M.D, Director of Clinical Research, Sheppard Pratt Health System
ClinicalTrials.gov Identifier: NCT01944657     History of Changes
Other Study ID Numbers: SPHS IRB [354612-3]
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Scott T. Aaronson, M.D, Sheppard Pratt Health System:
Major Depressive Disorder Clinical Outcomes
Transcranial Magnetic Stimulation
Standard Medication Monotherapy
Exploratory Field Study

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs