rTMS in Treatment Resistant Depression

NCT02080507 | Completed Results

• 1 other identifier: IRB00068138
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and efficacy of rTMS as an alternative treatment to ECT. The study will also provide data for a power analysis to support a larger clinical trial if there is evidence of a clinically relevant treatment effect.

Conditions

Depression

Keywords

rTMS; depression; ECT

Outcome Measures

Primary Outcomes (1)

• Depression Severity as Assessed by the Montgomery Åsberg Depression Rating Scale (MADRS) Score

  The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 60 points. A higher score indicates greater depressive symptoms.

  Baseline, Week 6

Secondary Outcomes (1)

• Quality of Life Assessed by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-Les-SF) Score

  Baseline, Week 6

Study Arms (2)

Active Neuronetics rTMS stimulator

ACTIVE COMPARATOR

Device: Active Neuronetics Transcranial Magnetic Stimulator. The Neuronetics transcranial magnetic stimulator is an FDA approved device. In the active group, magnetic power output will be delivered to the subject through the coils.

Device: Active Neuronetics rTMS stimulator

Inactive Neuronetics rTMS stimulator

SHAM COMPARATOR

Device: Inactive Neuronetics Transcranial Magnetic Stimulator. The Neuronetics transcranial magnetic stimulator is an FDA approved device. In the inactive group, no magnetic power output will be delivered to the subject through the coils.

Device: Inactive Neuronetics rTMS stimulator

Interventions

Active Neuronetics rTMS stimulator DEVICE

In the active group, magnetic power output will be delivered to the subject through the coils.

Also known as: Neuronetics

Active Neuronetics rTMS stimulator

Inactive Neuronetics rTMS stimulator DEVICE

In the inactive group, no magnetic power output will be delivered to the subject through the coils.

Also known as: Neuronetics

Inactive Neuronetics rTMS stimulator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of unipolar major depressive disorder or bipolar disorder, depressed phase and on medication to prevent a manic episode
• Pretreatment Montgomery Åsberg Depression Rating Scale (MADRS) score ≥ 20
• Over age 18 years
• Meeting criteria for ECT according to standards outlined in American Psychiatric Association Task Force on Electroconvulsive Therapy (2001) (American Psychiatric Association Task Force on Electroconvulsive Therapy: The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training and Privileging, Task Force Report on ECT, 2nd Edition. Washington, DC, American Psychiatric Association, 2001) and qualifying for ECT in the opinion of the study physician and the subject's psychiatric provider.
• Subjects may be on psychotropic medications including antidepressants, antipsychotics, benzodiazepines and anticonvulsants but the dosage of the medication must be stable for at least 6 weeks
• Able and willing to provide informed consent

You may not qualify if:

• Be pregnant or lactating, planning to become pregnant within the next three months or sexually active and not using birth control.
• \. Diagnosis with the following conditions (current unless otherwise stated):
• Have a neurological disorder, including a history of seizures, cerebrovascular disease, primary or secondary tumors in central nervous system, stroke, cerebral aneurysm or movement disorder or any lifetime history of loss of consciousness due to head injury.
• Any current Axis 1 psychotic disorder (including substance-induced psychosis, psychotic disorder due to a medical condition, or major depression with psychotic features), as defined by the MINI ( Mini International Neuropsychiatric Interview; English Version 7.0.0 for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); Copyright 1992---2014 Sheehan DV) at the screening visit;
• Any lifetime Axis 1 psychotic disorder (excluding substance-induced psychosis, or psychotic disorder due to a medical condition), or as defined by the MINI at the screening visit;
• Any current Axis II personality disorder that would interfere in the participation of the study as determined through medical history or in the opinion of the investigator;
• Have a current amnestic disorder, dementia, or delirium as defined by Montreal Cognitive Assessment of less than or equal to 16;
• Any illicit substance use as determined by positive toxicology screen for drugs of abuse; or alcohol and/or substance abuse or dependence within the past 3 months (90 days) as determined by the MINI at the screening visit
• Treatment histories including:
• Failure to clinically remit to an adequate trial of electroconvulsive therapy (ECT), defined as 8 bilateral or 10 unilateral treatments, in the current episode;
• Have failed prior treatment with vagal nerve stimulation (VNS);
• Prior treatment with TMS.
• Have active suicidal intent or plan as defined by a positive answer to questions 4 and/or 5 on the Columbia-Suicide Severity Rating Scale (CSSRS): Screening version; or more than one suicide attempt in lifetime; or a suicide attempt in the past twelve months; or in the Investigator's opinion, is likely to attempt suicide within the next six months.
• Participation in any drug or device clinical trial in the six weeks (42 days) prior to the screening visit and/or participation in another clinical trial for the duration of the study.
• Presence of any other condition or circumstance that, in the opinion of the investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University at Wesley Woods Hospital

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

The study sample was limited due to low recruitment.

Results Point of Contact

• Title: Dr. William McDonald
• Organization: Emory University

wmcdona@emory.edu

404-712-6945

Study Officials

• William M McDonald, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 6, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 30, 2017
• Results First Posted: May 30, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)