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Concurrent fMRI-guided rTMS and Cognitive Therapy for the Treatment of Major Depressive Episodes

This study is currently recruiting participants.
Verified August 8, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT03289923
First Posted: September 21, 2017
Last Update Posted: December 8, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
  Purpose

Background:

Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. It stimulates the brain. Researchers want to see if using magnetic resonance imaging (MRI) scans helps locate the best area for rTMS in each person. They also want to find other ways to make it more effective.

Objective:

To study the effects of combining MRI- guided transcranial magnetic stimulation (TMS) and talk therapy on the brain in people with depression.

Eligibility:

Adults ages 18 65 with a major depressive disorder and current depression. If taking an antidepressant, should have been doing so for at least 4 weeks.

Design:

Participants will be screened with medical and psychiatric history, psychiatric evaluation, physical exam, and blood and urine tests.

Phase 1 is 1 4 visits in 1 week. Participants will have:

Brain MRI. Participants will lie on a table in a scanner.

Questions about their medical history and psychology symptoms

Tests of mood and thinking

Tests of brain activity. Participants may do tasks during these tests:

A cone with magnetic detectors is put on the head.

A cap with electrodes is put on the scalp.

TMS. A brief electrical current passes through a wire coil on the scalp.

A metal disk will be placed on the arm. A nerve will be stimulated with a small electrical shock.

Phase 2 is about 6 to 7 weeks.

There will be 30 daily sessions of combined therapy and repetitive TMS (rTMS) for 6 weeks.

Participants will receive rTMS and another therapy by computer.

For rTMS, repeated pulses will pass through the coil.

This is followed by up to 3 additional visits, when:

Participants will repeat Phase 1 tests

Participants will rate their depression symptoms.

Phase 3 is 3 visits over 3 months. Participants will rate their depression symptoms and repeat some of the previous questionnaires and tests of mood and thinking.


Condition Intervention Phase
Major Depressive Disorder Other: TMS+SST Other: Sham TMS + Sham Therapy Device: TMS Behavioral: Cogntive Therapy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Concurrent fMRI-guided rTMS and Cognitive Therapy for the Treatment of Major Depressive Episodes

Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):

Primary Outcome Measures:
  • Change in magnitude of Bold signal [ Time Frame: Baseline 6 weeks ]

Secondary Outcome Measures:
  • Electrophysiological changes using MEG and EEG measures [ Time Frame: Baseline - +6 weeks ]
  • Clinical Rating Scales: BSL, C-SSRS, CTQ, HAM-A, NIH-BFI, PANAS, RBANS, RRS, SHAPS, and TLEQ [ Time Frame: Baseline - + 6weeks ]

Estimated Enrollment: 50
Anticipated Study Start Date: December 13, 2017
Estimated Study Completion Date: January 31, 2019
Estimated Primary Completion Date: January 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TMS+SST Other: TMS+SST
Transcranial Magnetic Stimulation (TMS) with Self System Therapy (SST)
Device: TMS
Transcranial Magnetic Stimulation (TMS)
Behavioral: Cogntive Therapy
Self-Systems Therapy (SST)
Sham Comparator: Sham Group Other: Sham TMS + Sham Therapy
Sham Transcranial Magnetic Stimulation (TMS) + Sham Therapy
Experimental: Active Group Other: TMS+SST
Transcranial Magnetic Stimulation (TMS) with Self System Therapy (SST)
Device: TMS
Transcranial Magnetic Stimulation (TMS)
Behavioral: Cogntive Therapy
Self-Systems Therapy (SST)

  Show Detailed Description

  Eligibility

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 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • 18 to 65 years of age.
  • Use of effective method of birth control for women able to become pregnant
  • Major Depressive Episode Diagnosis, Severity, and Duration:

    • Subjects will meet the DSM-IV-TR primary diagnosis of initial or recurrent Major Depressive Disorder by DSM-IV-TR criteria -- HAM-D score greater than 17 and Item 1 score greater than or equal to 2. Alternatively: At the initial screening and beginning of Phase II, subjects must have a baseline score on the MADRS greater than or equal to 20 and YMRS of less than 12.
    • Duration of current episode greater than 8 weeks. The definition of an episode is demarcated by a period of greater than 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.
  • Current or past history of lack of response to at least one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial (unless the ECT occurred within the last year, in which case the participant will be excluded).
  • If currently on a stable dose of antidepressant medication, the dosage has been unchanged for at least four weeks prior to study entry. The medication must be continued, and at the same dosage throughout study participation.
  • Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
  • All subjects must have undergone a screening assessment under protocol 01-M-0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers .
  • Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.

EXCLUSION CRITERIA:

- Pregnant or nursing women or women who plan to become pregnant in the next 20 weeks while in the study.

Persons who are able to get pregnant must be willing to use at least one form of effective birth control

during the entire period of study participation (or until last clinical labs and rating) and have a negative pregnancy

test at screening.

  • Current or recent (within the past 6 months) diagnosis of substance abuse or dependence (excluding nicotine and caffeine)
  • History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, known structural brain lesion.
  • Diagnosed with the following conditions (current unless otherwise stated):

    • Any other current primary Axis I mood or psychotic disorder, including bipolar disorder, with the exception of GAD.
    • Depression secondary to a general medical condition, or substance-induced.
    • 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 currently engaged or planning to engage in other treatment during the course of Phases I and II of the study (including behavior therapy, or other types of individual, family, or group psychotherapy/counseling), or subjects planning to start an antidepressant medication during the course of Phases I and II.
  • Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold. Excluded medications and substances include: imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel s dust), ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline.
  • Subjects with an unstable or serious medical or neurological disorder
  • Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications
  • Presence of ferromagnetic metal in the body, such as metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip).
  • Subjects who have hearing loss that has been clinically evaluated and diagnosed
  • Participants who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 90 minutes, and would feel uncomfortable in the MRI machine (for subjects doing imaging component of the study only).
  • Subjects with any of the following treatment histories:

    • Lifetime history of TMS treatment.
    • ECT treatments within 1 year prior to the screening.
    • Lifetime history of treatment with Deep Brain Stimulation or Vagus Nerve Stimulation.
    • Use of any investigational drug or device within 4 weeks of starting the study.
  • Clinically significant abnormal lab tests
  • Positive HIV test
  • Subjects who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.
  • A current NIMH employee/staff or their immediate family member.
  Contacts and Locations
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): NCT03289923


Contacts
Contact: Valeria Martinez-Kaigi (301) 827-0963 valeri.martinez@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Sarah H Lisanby, M.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT03289923     History of Changes
Other Study ID Numbers: 170147
17-M-0147
First Submitted: September 20, 2017
First Posted: September 21, 2017
Last Update Posted: December 8, 2017
Last Verified: August 8, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Transcranial Magnetic Stimulation (TMS)
Major Depressive Disorder
Cognitive Therapy

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms