Repetitive Transcranial Magnetic Stimulation for Treating Depression: A Functional Magnetic Resonance Imaging Study

NCT01162382 | Terminated Results DMC

• 1 other identifier: WUSM3621222-201110079
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol, "Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder (MDD): A Functional Connectivity Magnetic Resonance Imaging (fcMRI) Study," is an open-label pilot treatment study. The purpose of the present protocol is to treat participants with a diagnosis of Major Depressive Disorder with 4 weeks of rTMS, performing fcMRI and EEG studies prior to and following treatment to determine if treatment response is related to changes in fcMRI and/or EEG results. The investigators hypothesize that patients who respond to treatment will display changes in functional connectivity patterns thought to be related to the occurrence of depressive symptoms.

Conditions

Major Depressive Disorder

Keywords

transcranial magnetic stimulation; TMS; rTMS; depression; fcMRI; EEG

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale-24 Point Version (HDRS-24)

  HDRS-24 will be used to measure response to rTMS treatment. A 50% decrease in HDRS-24 score will indicate treatment response; HDRS-24 \< 10 will indicate remission.

  At study entry and within 2 days of exiting 4 weeks of rTMS treatment

Secondary Outcomes (1)

• fCMRI Results

  At study entry and within 2 days of exiting 4 weeks of rTMS treatment

Study Arms (1)

Transcranial Magnetic Stimulation

EXPERIMENTAL

Open-label transcranial magnetic stimulation

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex. Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex.

Also known as: Magstim Rapid stimulator

Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• SCREENING/DIAGNOSTIC REQUIREMENTS:
• Male or female outpatients, ages 18-50 (some literature has shown increasing cortical distance with age that may affect treatment outcome
• Hamilton Rating Scale of Depression (HRSD-24) \> 18
• New onset major depression or untreated recurrent major depression per DSM-IV-TR38 criteria.
• Not taking antidepressant medication or any other psychotropic medication
• Using an adequate contraceptive method
• Able to give informed consent
• Available for 4 weeks of daily therapy, working hours, Mon.-Fri.
• English-speaking

You may not qualify if:

• Co-morbid psychiatric diagnosis of bipolar disorder, acute OCD, schizophrenia or schizoaffective or concurrent treatment with outpatient ECT, or personality disorder or MDD with suicidal ideation as determined by history and/or by P.I. examination requiring hospital admission or referral for acute care.
• Previous failure to respond to treatment with rTMS
• Failure to achieve satisfactory improvement in depression after two or more adequate trials of antidepressant medications.
• Patients newly diagnosed with thyroid dysfunction
• History of drug and/or ETOH dependence
• History of seizures
• History of head injury with loss of consciousness \> 5 minutes
• Any implantable metal object in the skull or near their head
• Any implantable devices such as a cardiac pacemaker, vagal nerve stimulator, etc.
• Positive urine pregnancy test
• Severe migraine headaches uncontrolled with routine non-narcotic medication
• Any medical condition in the opinion of the Investigator that might confound the results of the study Contraindications to fcMRI procedure
• Intake of NSAIDS, narcotic or muscle relaxants within 72 hours of the fMRI protocol.
• Claustrophobia.
• Left-handedness (may influence cerebral cortical hemispheric dominance).

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

• Demitrack MA, Thase ME. Clinical significance of transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant depression: synthesis of recent data. Psychopharmacol Bull. 2009;42(2):5-38.

  PMID: 19629020 BACKGROUND

• Broyd SJ, Demanuele C, Debener S, Helps SK, James CJ, Sonuga-Barke EJ. Default-mode brain dysfunction in mental disorders: a systematic review. Neurosci Biobehav Rev. 2009 Mar;33(3):279-96. doi: 10.1016/j.neubiorev.2008.09.002. Epub 2008 Sep 9.

  PMID: 18824195 BACKGROUND

• O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.

  PMID: 17573044 BACKGROUND

• Savitz JB, Drevets WC. Imaging phenotypes of major depressive disorder: genetic correlates. Neuroscience. 2009 Nov 24;164(1):300-30. doi: 10.1016/j.neuroscience.2009.03.082. Epub 2009 Apr 7.

  PMID: 19358877 BACKGROUND

• Zou K, Deng W, Li T, Zhang B, Jiang L, Huang C, Sun X, Sun X. Changes of brain morphometry in first-episode, drug-naive, non-late-life adult patients with major depression: an optimized voxel-based morphometry study. Biol Psychiatry. 2010 Jan 15;67(2):186-8. doi: 10.1016/j.biopsych.2009.09.014.

  PMID: 19897176 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

No data are available for this study as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed.

Results Point of Contact

• Title: Kathy Pierce
• Organization: Washington University School of Medicine

jenkerson_m@wustl.edu

314-362-5626

Study Officials

• Jose Garcia, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: July 14, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 18, 2019
• Results First Posted: February 18, 2019

Record last verified: 2019-02

Locations

US (1)