DepressionrTMSNCT01115699
Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as Adjuvant Treatment for Depression
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Depression, run by Mayo Clinic at 1 site in United States.
Trial summary
The study will systematically investigate the use of repetitive transcranial magnetic stimulation (rTMS) in non-remitters of a selective serotonin reuptake inhibitor (SSRI) followed by a serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to identify gene variants that predict rTMS response. Read more about this study
- Who is it for?
- Ages 18 to 85 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?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Mar 2012
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects whose depressive symptoms have not remitted during their participation in the "Pharmacokinetics and Pharmacodynamics of Citalopram and Escitalopram" study or the "Pharmacokinetics and Pharmacodynamics of Duloxetine" study
- Must be able to continue to take same dose of duloxetine through the course of the study
Who cannot join
- A history of failure for respond to Electroconvulsive Therapy (ECT)
- Any metal in the head (except in mouth)
- Implanted medication pump or cardiac pacemaker
- Have had prior brain surgery
- Have unprovoked seizure disorder or family history of treatment resistant epilepsy
- Pregnancy
- Psychiatric hospitalization within the past two weeks
- Suicide attempt with hospitalization within past three months
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Pilot Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as Adjuvant Treatment in Patients With Non-remitting Depression: Third Stage of Citalopram/Escitalopram Study
The study will systematically investigate the use of repetitive transcranial magnetic stimulation (rTMS) in non-remitters of a selective serotonin reuptake inhibitor (SSRI) followed by a serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to identify gene variants that predict rTMS response.
Read the detailed description
This is the first study of its kind to systematically investigate the use of repetitive transcranial magnetic stimulation (rTMS) in non-remitters of a selective serotonin-reuptake inhibitor (SSRI) followed by an serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to identify gene variants that predict rTMS response. The study is similar in design to the STAR*D study in that it will be the third treatment stage for a study of subjects with major depressive disorder (MDD). rTMS is a novel intervention which was FDA approved for treatment of MDD in October 2008 and was not clinically available at the time of the STAR*D study.
The primary aim of this pilot study is to provide 10 Hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) as adjuvant treatment for depression in individuals who have not had a remission of their depressive symptoms after an 8 week trial of an SSRI (citalopram or escitalopram) followed by an 8 week trial of an SNRI, duloxetine and identify gene variants associated with improvement of their depressive symptoms.
- Conditions
- Depression
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Keywords
- Depression, rTMS
- Medical subject headings
- Depression
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
Active 10 Hz rTMS will be applied to the left dorsolateral prefrontal cortex (L-DLPFC) with an intensity of 120% motor threshold. The L-DLPFC location is defined as that area 5 cm anterior to the motor cortex for activation of abductor pollicis brevis. Subjects will receive a total of 3000 stimuli per session. The TMS trains are 4 seconds on and 26 seconds off for a total of 37 1/2 minutes. Treatment will occur 5 days per week for up to six weeks. Subjects will be monitored during rTMS for any side effects or adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Experimental | All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Rating Scale for Depression (HRS-D17)
The HRS-D17 questionnaire has 17 items. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.
Measured: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks
Secondary outcomes (1)
Change in Quick Inventory of Depressive Symptoms - Clinician Rating 16 Item (QIDS-C16)
The QIDS-C16 measures 16 factors across 9 different criterion domains for major depression. Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following:the highest number from questions 1-4 + the number from question 5 + the highest number from questions 6-9 + the total of each question from 10-14 + the highest number from questions 15-16.
Screening test scoring ranges:
- 0-5, No Depression Likely
- 6-10, Possibly Mildly Depressed
- 11-15, Moderate Depression
- 16-20, Severe Depression
- 21 or Over, Very Severe Depression
Measured: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Stopped due to funding constraints and recruitment was slower than was expected
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.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Neuronetics
- Responsible party
- Principal investigator, David Mrazek, Mayo Clinic
- Investigators
- David Mrazek, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115699
- Sponsor's protocol ID
- 10-000401
- Acronym
- rTMS
- Status last verified
- Oct 2013
- First submitted
- 30 Apr 2010
- Last updated
- 13 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as Adjuvant Treatment in Patients With Non-remitting Depression: Third Stage of Citalopram/Escitalopram Study
- ClinicalTrials.gov ID
- NCT01115699
- Acronym / sponsor ID
- rTMS / 10-000401
- Conditions
- Depression
- Keywords
- Depression, rTMS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped due to funding constraints and recruitment was slower than was expected
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Neuronetics
- Study start
- Apr 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Posted 13 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will systematically investigate the use of repetitive transcranial magnetic stimulation (rTMS) in non-remitters of a selective serotonin reuptake inhibitor (SSRI) followed by a serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to identify gene variants that predict rTMS response.
Detailed description
This is the first study of its kind to systematically investigate the use of repetitive transcranial magnetic stimulation (rTMS) in non-remitters of a selective serotonin-reuptake inhibitor (SSRI) followed by an serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to identify gene variants that predict rTMS response. The study is similar in design to the STAR*D study in that it will be the third treatment stage for a study of subjects with major depressive disorder (MDD). rTMS is a novel intervention which was FDA approved for treatment of MDD in October 2008 and was not clinically available at the time of the STAR*D study.
The primary aim of this pilot study is to provide 10 Hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) as adjuvant treatment for depression in individuals who have not had a remission of their depressive symptoms after an 8 week trial of an SSRI (citalopram or escitalopram) followed by an 8 week trial of an SNRI, duloxetine and identify gene variants associated with improvement of their depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects whose depressive symptoms have not remitted during their participation in the "Pharmacokinetics and Pharmacodynamics of Citalopram and Escitalopram" study or the "Pharmacokinetics and Pharmacodynamics of Duloxetine" study
- Must be able to continue to take same dose of duloxetine through the course of the study
Key exclusion criteria (8 listed)
- A history of failure for respond to Electroconvulsive Therapy (ECT)
- Any metal in the head (except in mouth)
- Implanted medication pump or cardiac pacemaker
- Have had prior brain surgery
- Have unprovoked seizure disorder or family history of treatment resistant epilepsy
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)Active 10 Hz rTMS will be applied to the left dorsolateral prefrontal cortex (L-DLPFC) with an intensity of 120% motor threshold. The L-DLPFC location is defined as that area 5 cm anterior to the motor cortex for activation of abductor pollicis brevis. Subjects will receive a total of 3000 stimuli per session. The TMS trains are 4 seconds on and 26 seconds off for a total of 37 1/2 minutes. Treatment will occur 5 days per week for up to six weeks. Subjects will be monitored during rTMS for any side effects or adverse events. | Device | Repetitive Transcranial Magnetic Stimulation |
Primary outcome
Change in Hamilton Rating Scale for Depression (HRS-D17)
Time frame: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks
The HRS-D17 questionnaire has 17 items. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.
1 secondary outcome
Change in Quick Inventory of Depressive Symptoms - Clinician Rating 16 Item (QIDS-C16)
Time frame: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Mrazek, MD principal investigator
Mayo Clinic
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 Mayo Clinic 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 2 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: stopped early, as of the sponsor's last update on 13 Dec 2013. 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. 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 13 Dec 2013). 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?
Change in Hamilton Rating Scale for Depression (HRS-D17) (time frame: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2013.