Neurophysiologic Predictors of Outcome With rTMS Treatment of Major Depressive Disorder

NCT00956514 | Completed Phase 4

• 2 other identifiers: 09-02-045IRB# 09-02-045
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Transcranial magnetic stimulation (TMS) therapy has proven to lead to symptom improvement in many individuals with major depressive disorder (MDD), yet there is heterogeneity in outcome, with some patients showing robust remission and other showing minimal symptom change. Identifying which individuals are likely to benefit from TMS therapy early in the course of treatment would support continued treatment for those predicted to do well, and consideration of alternative treatments for others individuals. This study will test specific hypotheses about the relationships between early neurophysiologic changes and later clinical outcome with TMS treatment.

Conditions

Depression

Keywords

depression; major depressive disorder; transcranial magnetic stimulation; TMS; EEG; electroencephalography; Major Depression,

Outcome Measures

Primary Outcomes (3)

• Change in HAM-D17 scale score

  baseline, week one, end of week 6

• Change in MADRS scale score

  Baseline, week 1, end of week 6

• Change in IDS-SR30 scale score

  baseline, week one, end of week 6

Study Arms (1)

Transcranial Magenetic Stimulation

EXPERIMENTAL

All subjects will be assigned to active, open-label treatment with the NeuroStar TMS System for 6 weeks (30 treatment sessions).

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

Neurophysiologic Predictors of Outcome with rTMS Treatment of Major Depressive Disorder

Transcranial Magenetic Stimulation

Eligibility Criteria

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

You may qualify if:

• Outpatients with non-psychotic, unipolar Major Depressive Disorder (MDD) assessed via the MINI structured interview
• A score of ≥ 20 on the HAM-D17 with Item 1 (depressed mood) ≥ 2
• A history of treatment failure with at least one adequate trial of an antidepressant and not more than 2 trials, in the current episode, assessed by the ATHF
• Age range: 18-64.
• Patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm.

You may not qualify if:

• Patient is mentally or legally incapacitated, unable to give informed consent.
• Patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); current MMSE ≤ 24; delirium or substance abuse within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
• Patients with exposure to ECT within the past 6 months, previous TMS treatment for any condition, or VNS treatment (lifetime).
• Patients who have met diagnostic criteria for any current substance abuse disorder at any time in the 6 months prior to enrollment.
• Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, CVA, or TIAs; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
• Any history of intracranial implant; implanted cardiac pacemaker, defibrillator, vagus nerve stimulator, deep brain stimulator; or other implanted devices or objects contraindicated by product labeling.
• current pregnancy, breast feeding, or not using a medically accepted means of contraception.
• Other medical contraindications to any of the study procedures

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Depression Research and Clinic Program

Los Angeles, California, 90024-1759, United States

Location

Related Links

• UCLA Depression Research and Clinic Program
• Transcranial Magnetic Stimulation in Los Angeles

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Ian A Cook, MD

  UCLA Depression Research and Clinic Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 11, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 6, 2013

Record last verified: 2013-02

Locations

US (1)