NCT01909232

Brief Summary

The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant medications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

July 22, 2013

Last Update Submit

July 25, 2016

Conditions

Depressive Disorder, Major

Keywords

DepressionDepressive DisorderMajor depressionMajor depressive disorderMDDTreatment resistant depressionTreatment intolerant depressionTRMDTIMDTranscranial Magnetic StimulationTMS

Outcome Measures

Primary Outcomes (1)

  • Change in depression severity

    Measured by the 24-item Hamilton Rating Scale for Depression

    Baseline to four weeks (the conclusion of rTMS treatment)

Secondary Outcomes (8)

  • Change in depression severity

    Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)

  • Clinically significant response

    Baseline to four weeks (the conclusion of rTMS treatment)

  • Clinically significant response

    Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)

  • Remission from depression

    Baseline to four weeks (the conclusion of rTMS treatment)

  • Remission from depression

    Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)

  • +3 more secondary outcomes

Study Arms (2)

Active rTMS treatment

EXPERIMENTAL

Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

Device: Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

Sham rTMS treatment

SHAM COMPARATOR

Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

Device: Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

Interventions

Active Cervel Neurotech Multi-Coil Transcranial Magnetic StimulatorDEVICE

The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the active group, magnetic power output will be delivered to the subject through the coils.

Active rTMS treatment
Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic StimulatorDEVICE

The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the inactive group, no magnetic power output will be delivered to the subject through the coils.

Sham rTMS treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current major depressive disorder (MDD)
  • Resistance or intolerance to antidepressant medication in the current depressive episode, or intolerance to antidepressant medication in a past depressive episode
  • On a stable psychotropic regimen prior to screening and be willing to maintain the current regimen and dosing for the duration of the study
  • Weight less than 350 pounds

You may not qualify if:

  • Current major depressive disorder episode of more than three years
  • Seizure disorder
  • History of brain injury, stroke or active central nervous system disease
  • Cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord unless deemed MRI-safe
  • Active suicidal intent or plan
  • Other significant psychiatric disorder
  • Alcohol or substance dependence or abuse
  • Prior treatment with transcranial magnetic stimulation
  • Have failed to clinically remit to an adequate trial of electroconvulsive therapy or vagus nerve stimulation
  • If female, pregnant or lactating or planning to become pregnant within the next three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Emory University

Atlanta, Georgia, 30306, United States

Location

Sheppard-Pratt Health System

Baltimore, Maryland, 21285, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

CRI Lifetree

Salt Lake City, Utah, 84106, United States

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepressionDepressive DisorderDepressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Beth Stannard, BS, CCRP, CCRC

    Cervel Neurotech

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2013

First Posted

July 26, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

July 28, 2016

Record last verified: 2016-07

Locations

US(6)