DepressionPhase 2/3NCT00149838

Magnetic Brain Stimulation for the Treatment of Adult Depression

A Phase 2/3 study testing Prefrontal rTMS and Antidepressant Regimen in people with Depression, run by Medical University of South Carolina at 4 sites 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

This study will evaluate the safety and effectiveness of magnetic brain stimulation for the treatment of major depression in depressed adults with moderate treatment resistance. Read more about this study

Who is it for?: Ages 21 to 70 years
Conditions the study is for: Depression
What is being tested?: Prefrontal rTMS and Antidepressant Regimen
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 190 participants
Where: 4 sitesUnited States
Study dates: Feb 2005to May 2009
Phase: Phase 2/3
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 21 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of major depression with a current episode
Hamilton Rating Scale for Depression score higher than 20
No response or intolerance to antidepressant medication in the current depressive episode

Who cannot join

Current use of antidepressants
Diagnosis of psychosis or anxiety disorder
Current substance abuse
Seizures or history of head trauma

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Emory University
Atlanta, Georgia, 30329-5102
Brain Stimulation Laboratory, Medical University of South Carolina
Charleston, South Carolina, 29425
Columbia University
New York, New York, 10032
University of Washington
Seattle, Washington, 98104-2499

Other trials in United States

About this study

Official title: Optimization of Transcranial Magnetic Stimulation (TMS) for Depression

This study will evaluate the safety and effectiveness of magnetic brain stimulation for the treatment of major depression in depressed adults with moderate treatment resistance.

Read the detailed description

Major depression is a type of depression that can interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. Because people often develop resistances to medications used to treat depression, new treatments are needed. Decreased electrical activity in the prefrontal region of the brain has been linked to some symptoms of depression. Repetitive transcranial magnetic stimulation (rTMS) can be used to influence the brain's electrical activity. This procedure entails attaching electrodes to the head and using a device to pass magnetic energy through coils and into the brain. rTMS has been shown to have antidepressant effects in depressed individuals. However, optimal levels of intensity and treatment duration have yet to be determined. This study will assess the safety and effectiveness of rTMS on the prefrontal region of the brain in depressed adults with moderate treatment resistance.

The treatment phase of this double-blind study will last a minimum of 32 weeks and will consist of 3 phases. In Phase I, participants will be randomly assigned to receive either rTMS or sham stimulation. The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks. In Phase II, participants who were unresponsive to Phase I treatment will receive daily rTMS at a lower dose for 3 weeks. Participants who show signs of improvement, but have not achieved remission, may continue Phase II for 4 additional weeks. Baseline magnetic resonance images will be used to determine the optimal stimulus intensity by adjusting for individual differences in cortical to skull distances. Phase III participants will be only those who achieved remission in the first 2 phases. These participants will receive antidepressant medication treatment daily for six months. Participants' functional status and symptoms of depression will be measured using self-report scales and video-recorded interviews at study start date and at the end of each treatment phase.

Conditions: Depression
Being tested: Prefrontal rTMS, Antidepressant Regimen, Sham Stimulation
Keywords: Electric Stimulation, Magnetic Stimulation, Prefrontal Cortex, Brain
Medical subject headings: Depression

What participants receive

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

Prefrontal rTMSProcedure or surgery
Also called TMS, rTMS
Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.
Antidepressant RegimenDrug
Also called medication
Particpants who acheive remission with rTMS may start antidepressant medication in phase III.
Sham StimulationProcedure or surgery
The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks.

Study groups in NCT00149838
Study group	Role	What they receive
Active prefrontal rTMS phase1	Experimental	Phase I participants receiving rTMS Receives: Procedure: Prefrontal rTMS
Sham rTMS phase 1	Placebo comparator	Phase I participants receiving sham stimulation Receives: Procedure: Sham Stimulation
rTMS extension	Experimental	rTMS. Phase II participants, all of whom did not meet remission requirements after phase 1. They all receive active open label rTMS Receives: Procedure: Prefrontal rTMS
Open label antidepressant regimen	Experimental	All patients who met remission who were then transitioned to medications after the TMS trial was completed. Receives: Drug: Antidepressant Regimen

What is being measured

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

Depression Remission, as Measured by the Hamilton Rating Scale for Depression
The Hamilton Rating Scale for Depression 17-item total score ranges from 0 to 52 with higher scores indicating more depression. Remission is defined as a total score of ≤ 8
Measured: Measured at the end of Phases 1, 2, and 3

Timeline

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

Feb 2005May 2009

First posted8 Sep 2005 (estimated)
Study startFeb 2005
Primary completionApr 2009
Study completionMay 2009

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 (2)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00149838
Sponsor's protocol ID: R01MH069887
Other IDs: R01MH069887, DATR A5-ETMA
Status last verified: Dec 2018
First submitted: 6 Sep 2005
Last updated: 28 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Interested researchers can email the PI, Dr. George, with a request and how they plan to analyze the data. He will then make available a de-identified copy of the data.

Publications

Borckardt JJ, Nahas ZH, Teal J, Lisanby SH, McDonald WM, Avery D, Durkalski V, Pavlicova M, Long JM, Sackeim HA, George MS. The painfulness of active, but not sham, transcranial magnetic stimulation decreases rapidly over time: results from the double-blind phase of the OPT-TMS Trial. Brain Stimul. 2013 Nov;6(6):925-8. doi: 10.1016/j.brs.2013.04.009. Epub 2013 May 21.
PubMed 23769413
George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
PubMed 20439832

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 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimization of Transcranial Magnetic Stimulation (TMS) for Depression
ClinicalTrials.gov ID: NCT00149838
Acronym / sponsor ID: R01MH069887
Conditions: Depression
Keywords: Electric Stimulation, Magnetic Stimulation, Prefrontal Cortex, Brain
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 190 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Feb 2005
Primary completion: Apr 2009 (actual)
Study completion: May 2009 (actual)
First posted: 8 Sep 2005 (estimated)
Results: Posted 28 Dec 2018

Clinical summary

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

This study will evaluate the safety and effectiveness of magnetic brain stimulation for the treatment of major depression in depressed adults with moderate treatment resistance.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Active prefrontal rTMS phase1	Experimental	Procedure: Prefrontal rTMSPhase I participants receiving rTMS
Sham rTMS phase 1	Placebo comparator	Procedure: Sham StimulationPhase I participants receiving sham stimulation
rTMS extension	Experimental	Procedure: Prefrontal rTMSrTMS. Phase II participants, all of whom did not meet remission requirements after phase 1. They all receive active open label rTMS
Open label antidepressant regimen	Experimental	Drug: Antidepressant RegimenAll patients who met remission who were then transitioned to medications after the TMS trial was completed.

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of major depression with a current episode
Hamilton Rating Scale for Depression score higher than 20
No response or intolerance to antidepressant medication in the current depressive episode

Key exclusion criteria (4 listed)

Current use of antidepressants
Diagnosis of psychosis or anxiety disorder
Current substance abuse
Seizures or history of head trauma

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
Prefrontal rTMSAlso: TMS, rTMSParticipants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.	Procedure or surgery	Active prefrontal rTMS phase1, rTMS extension
Antidepressant RegimenAlso: medicationParticpants who acheive remission with rTMS may start antidepressant medication in phase III.	Drug	Open label antidepressant regimen
Sham StimulationThe sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks.	Procedure or surgery	Sham rTMS phase 1

Primary outcome

Depression Remission, as Measured by the Hamilton Rating Scale for Depression
Time frame: Measured at the end of Phases 1, 2, and 3
The Hamilton Rating Scale for Depression 17-item total score ranges from 0 to 52 with higher scores indicating more depression. Remission is defined as a total score of ≤ 8

Results and safety

Results posted to the registry on 28 Dec 2018, 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 TMS	92	72
Sham TMS	98	82
rTMS Extension	0	0
Open Label Antidepressant Regimen	0	0

Primary outcome: Depression Remission, as Measured by the Hamilton Rating Scale for Depression

Time frame: Measured at the end of Phases 1, 2, and 3. Number. Unit: number of remitted patients

Measure	Active TMS n = 92	Sham TMS n = 98	Active Open for 3 Weeks n = 141	Medication Followup n = 55
Value	13	5	43	12

Population analysed: Remission

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active TMS	0 of 92 (0%)	18 of 92 (19.6%)	Not reported
Sham TMS	0 of 98 (0%)	15 of 98 (15.3%)	Not reported
rTMS Extension	0 of 144 (0%)	0 of 144 (0%)	Not reported
Open Label Antidepressant Regimen	0 of 61 (0%)	0 of 61 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23769413Borckardt JJ, Nahas ZH, Teal J, Lisanby SH, McDonald WM, Avery D, Durkalski V, Pavlicova M, Long JM, Sackeim HA, George MS. The painfulness of active, but not sham, transcranial magnetic stimulation decreases rapidly over time: results from the double-blind phase of the OPT-TMS Trial. Brain Stimul. 2013 Nov;6(6):925-8. doi: 10.1016/j.brs.2013.04.009. Epub 2013 May 21.
Derived from this study: PubMed 20439832George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
Individual participant dataSharing planned: Yes. Interested researchers can email the PI, Dr. George, with a request and how they plan to analyze the data. He will then make available a de-identified copy of the data.

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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.

Mark S. George, MD principal investigator

Medical University of South Carolina

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Prefrontal rTMS and Antidepressant Regimen in people with Depression, run by Medical University of South Carolina at 4 sites 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 3 inclusion and 4 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 28 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2018). 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?

Depression Remission, as Measured by the Hamilton Rating Scale for Depression (time frame: Measured at the end of Phases 1, 2, and 3). 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 NCT00149838, which also lists 2 linked publications.

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 28 Dec 2018.