DepressionNCT01900314

Imaging Biomarkers for TMS Treatment of Depression

A study testing repetitive Transcranial Magnetic Stimulation (rTMS) in people with Depression, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 22 to 65 years
Conditions the study is for: Depression
What is being tested?: repetitive Transcranial Magnetic Stimulation (rTMS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Sep 2013to Apr 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Primary diagnosis of major depressive disorder
Male and female subjects, ages 22-65
Have failed at least 1 antidepressant medication at adequate dose and duration
On stable antidepressant medication regimen for at least 4 weeks prior to TMS therapy

Who cannot join

Diagnosed with a psychotic, bipolar, obsessive-compulsive or post-traumatic stress disorder
Active substance abuse, including alcohol
Medical and/or neurological condition that could affect your brain function or risk of seizure, including a stroke, epilepsy, or a closed head injury;
No presence of an implanted device like a pacemaker/neurostimulator or metal in the head or body;
Pregnant or trying to get pregnant
Failed to respond to an adequate course of electroconvulsive therapy (ECT)
Previous treatment with TMS
Current depressive episode longer than 5 years

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

The purpose of this research is to learn more about how rTMS works to reduce the symptoms of depression. This information can be used to improve the effectiveness of the treatment. The study will use functional magnetic resonance imaging (fMRI) to examine changes in brain function after treatment with rTMS. fMRI is a safe and painless technique that allows investigators to observe the brain "at work." The investigators will use fMRI to see what regions of the brain become active when you perform a concentration task and how that activation is changed after rTMS.

Conditions: Depression
Being tested: repetitive Transcranial Magnetic Stimulation (rTMS)
Keywords: Major Depression, Major Depressive Disorder, TMS, rTMS
Medical subject headings: Depression, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

repetitive Transcranial Magnetic Stimulation (rTMS)Device
Also called TMS, NeuroStar, Sham treatment
20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.

Study groups in NCT01900314
Study group	Role	What they receive
Active rTMS	Active comparator	20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second fMRI will be completed then 5 additional tapering treatments of rTMS over a 2 week period. Receives: Device: repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMS	Sham comparator	20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second fMRI scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period. Receives: Device: repetitive Transcranial Magnetic Stimulation (rTMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Depressive Symptoms at 4 Weeks
MADRS: Montgomery Asberg Depression Rating Scale Range: 0 - 60 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression
Measured: 4 weeks after baseline

Secondary outcomes (1)

Depression Symptoms at 4 Weeks- Secondary
Depressive symptoms as measured by the 17-item Hamilton Depression Rating Scale (HRSD17) Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22
Measured: 4 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Apr 2016

First posted16 Jul 2013 (estimated)
Study startSep 2013
Primary completionJan 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01900314
Sponsor's protocol ID: HUM00053677
Other IDs: 1R21MH098174-01A1
Status last verified: Apr 2017
First submitted: 11 Jul 2013
Last updated: 25 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Taylor SF, Ho SS, Abagis T, Angstadt M, Maixner DF, Welsh RC, Hernandez-Garcia L. Changes in brain connectivity during a sham-controlled, transcranial magnetic stimulation trial for depression. J Affect Disord. 2018 May;232:143-151. doi: 10.1016/j.jad.2018.02.019. Epub 2018 Feb 21.
PubMed 29494898

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Imaging Biomarkers for TMS Treatment of Depression
ClinicalTrials.gov ID: NCT01900314
Acronym / sponsor ID: HUM00053677
Conditions: Depression
Keywords: Major Depression, Major Depressive Disorder, TMS, rTMS
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH), Neuronetics
Study start: Sep 2013
Primary completion: Jan 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 16 Jul 2013 (estimated)
Results: Posted 25 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Active rTMS	Active comparator	Device: repetitive Transcranial Magnetic Stimulation (rTMS)20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second fMRI will be completed then 5 additional tapering treatments of rTMS over a 2 week period.
Sham rTMS	Sham comparator	Device: repetitive Transcranial Magnetic Stimulation (rTMS)20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second fMRI scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.

Who may qualify

Ages: 22 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Primary diagnosis of major depressive disorder
Male and female subjects, ages 22-65
Have failed at least 1 antidepressant medication at adequate dose and duration
On stable antidepressant medication regimen for at least 4 weeks prior to TMS therapy

Key exclusion criteria (8 listed)

Diagnosed with a psychotic, bipolar, obsessive-compulsive or post-traumatic stress disorder
Active substance abuse, including alcohol
Medical and/or neurological condition that could affect your brain function or risk of seizure, including a stroke, epilepsy, or a closed head injury;
No presence of an implanted device like a pacemaker/neurostimulator or metal in the head or body;
Pregnant or trying to get pregnant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
repetitive Transcranial Magnetic Stimulation (rTMS)Also: TMS, NeuroStar, Sham treatment20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.	Device	Active rTMS, Sham rTMS

Primary outcome

Depressive Symptoms at 4 Weeks
Time frame: 4 weeks after baseline
MADRS: Montgomery Asberg Depression Rating Scale Range: 0 - 60 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression

1 secondary outcome

Depression Symptoms at 4 Weeks- Secondary
Time frame: 4 weeks after baseline

Results and safety

Results posted to the registry on 25 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active rTMS	20	16
Sham rTMS	20	16

Primary outcome: Depressive Symptoms at 4 Weeks

Time frame: 4 weeks after baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Active rTMS n = 16	Sham rTMS n = 16
Value	15.6 (8.3)	15.6 (8.3)

Active rTMS vs Sham rTMS: p = 0.16, ANCOVA

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events assessed during 4 weeks of double-blinded treatment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active rTMS	0 of 17 (0%)	4 of 17 (23.5%)	Not reported
Sham rTMS	0 of 17 (0%)	5 of 17 (29.4%)	Not reported

Limitations and caveats (from the sponsor): Small size, not powered for group differences. Primary measure was not clinical, but brain changes (primary measures for this report have only focused on clinical changes as neural changes cannot be entered into this reporting format

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29494898Taylor SF, Ho SS, Abagis T, Angstadt M, Maixner DF, Welsh RC, Hernandez-Garcia L. Changes in brain connectivity during a sham-controlled, transcranial magnetic stimulation trial for depression. J Affect Disord. 2018 May;232:143-151. doi: 10.1016/j.jad.2018.02.019. Epub 2018 Feb 21.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephan F Taylor, MD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing repetitive Transcranial Magnetic Stimulation (rTMS) in people with Depression, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depressive Symptoms at 4 Weeks (time frame: 4 weeks after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01900314, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.