Major Depressive DisorderNCT01502033

Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens

A study testing Transcranial Magnetic Stimulation in people with Major Depressive Disorder, run by Paul E. Croarkin 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

This research study aims to test the safety and effectiveness of repetitive transcranial magnetic stimulation (rTMS) on teens with depression. The study also seeks to understand how rTMS treatment affects the neurobiology of teens with depression. Read more about this study

Who is it for?: Ages 13 to 18 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Transcranial Magnetic Stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Dec 2011to Dec 2013
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 13 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features
Pretreatment CDRS-R Raw score ≥ 40
Age is at least 13 and less than 19 years
Ongoing, stable dose antidepressant therapy for at least 6 weeks to include the following antidepressants (with dosing range):
Celexa (citalopram hydrobromide) - 10 to 60mg
Cymbalta (duloxetine) - 40mg to 120mg

Show all 17Show fewer

Desyrel (trazodone HCl) - 12.5mg to 150mg
Effexor (venlafaxine HCl) - 37.5mg to 300mg
Luvox (fluvoxamine maleate) - 25mg to 200mg
Lexapro (escitalopram oxalate) - 10mg to 40mg
Paxil (paroxetine HCl) - 10mg to 50mg
Pristiq (desvenlafaxine) - 50mg to 100mg
Prozac (fluoxetine HCl) - 10mg to 80mg
Remeron (mirtazapine) - 7.5mg to 45mg
Zoloft (sertraline HCl) - 25mg to 200mg
Subjects able to attend at least 31 study visits at Mayo Clinic - Rochester
Willing to provide informed assent (adolescent) and informed consent (family)

Who cannot join

Subjects currently on stimulant, antipsychotic, bupropion or tricyclic antidepressant medications.
Prior rTMS, vagus nerve stimulation (VNS) or electroconvulsive therapy (ECT)
Contraindication to MRI
Contraindication to rTMS (history of neurological disorder such as seizures, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for >15 minutes, history of stroke, family history of epilepsy, intracardiac lines, Anticoagulant, immune suppressive and/or chemotherapy, or those who received any of these therapies within 3 months before enrollment in the study Unstable medication conditions such as hematological or infectious (e.g., human immunodeficiency virus-HIV) disorders, implanted electronic device, metal in the head, or pregnancy)
History of schizophrenia, schizoaffective disorder, other [non mood disorder] psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), bipolar disorder, psychotic features in this or previous episodes, amnestic disorder, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder
History of autoimmune, endocrine, viral, or vascular disorder.
Unstable cardiac disease, uncontrolled hypertension, or sleep apnea
Active suicidal intent or plan, or history of attempt within the past 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: An Open-Label Eight-Week Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents: Mechanisms of Response

Read the detailed description

This study aims to:

Evaluate the antidepressant effect and safety of rTMS in adolescents meeting criteria for major depressive disorder, single or recurrent episode.
Evaluate, by proton magnetic resonance spectroscopy (1H-MRS) at 3 Tesla (3T), the regional specificity [anterior cingulate (AC) vs. left dorsolateral prefrontal cortex (L-DLPFC)] of cerebral metabolites (glutamate and glutamine) in adolescent depression and study whether glutamine resonances are associated with response or remission of clinical depressive symptoms when rTMS is used to treat adolescent depression.
Evaluate the accuracy of an efficient method for locating the F3 position (i.e., L-DLPFC) through comparison with magnetic resonance imaging (MRI).

Conditions: Major Depressive Disorder
Being tested: Transcranial Magnetic Stimulation
Keywords: Adolescent Depression, Transcranial Magnetic Stimulation
Medical subject headings: Depressive Disorder, Major

What participants receive

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

Transcranial Magnetic StimulationDevice
Also called NeuroStar
30 daily treatments of (over 6-8 weeks) of 10 Hz rTMS at 120% motor threshold, applied to the left dorsolateral prefrontal cortex with 3,000 stimulations per treatment

Study groups in NCT01502033
Study group	Role	What they receive
Transcranial Magnetic Stimulation	Experimental	Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session. Receives: Device: Transcranial Magnetic Stimulation

What is being measured

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

Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)
The Children's Depression Rating Scale-Revised (CDRS-R) is a validated, 17-item, semi-structured clinician rating tool to assess severity of depression with subject and parental input for 14 of the 17 items.
Measured: 5 days of Treatment 30 or Last Treatment

Secondary outcomes (2)

Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)
The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a 7-point scale with which the clinician rates severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= normal, not ill at all; 7= among the most ill patients; larger number indicates greater severity of symptoms or worse outcome).
Measured: Within 5 days of Treatment 30 or Last Treatment
The Clinical Global Impression - Improvement (CGI-I)
The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates improvment of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= very much improved, 7=very much worse) larger number indicates greater severity of symptoms or worse outcome).
Measured: Within 5 days of 30 treatments or after last treatment in case of early withdrawal

Timeline

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

Dec 2011Dec 2013

First posted30 Dec 2011 (estimated)
Study startDec 2011
Primary completionMay 2013
Study completionDec 2013

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 (3)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
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: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01502033
Sponsor's protocol ID: 11-004500
Status last verified: Apr 2016
First submitted: 27 Dec 2011
Last updated: 22 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Wall CA, Croarkin PE, McClintock SM, Murphy LL, Bandel LA, Sim LA, Sampson SM. Neurocognitive effects of repetitive transcranial magnetic stimulation in adolescents with major depressive disorder. Front Psychiatry. 2013 Dec 12;4:165. doi: 10.3389/fpsyt.2013.00165. eCollection 2013.
PubMed 24376426
Sonmez AI, Kucuker MU, Lewis CP, Kolla BP, Doruk Camsari D, Vande Voort JL, Schak KM, Kung S, Croarkin PE. Improvement in hypersomnia with high frequency repetitive transcranial magnetic stimulation in depressed adolescents: Preliminary evidence from an open-label study. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Mar 8;97:109763. doi: 10.1016/j.pnpbp.2019.109763. Epub 2019 Oct 18.
PubMed 31634515
Wall CA, Croarkin PE, Maroney-Smith MJ, Haugen LM, Baruth JM, Frye MA, Sampson SM, Port JD. Magnetic Resonance Imaging-Guided, Open-Label, High-Frequency Repetitive Transcranial Magnetic Stimulation for Adolescents with Major Depressive Disorder. J Child Adolesc Psychopharmacol. 2016 Sep;26(7):582-9. doi: 10.1089/cap.2015.0217. Epub 2016 Feb 5.
PubMed 26849202

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?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Eight-Week Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents: Mechanisms of Response
ClinicalTrials.gov ID: NCT01502033
Acronym / sponsor ID: 11-004500
Conditions: Major Depressive Disorder
Keywords: Adolescent Depression, Transcranial Magnetic Stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Paul E. CroarkinUniversity, hospital or other
Study start: Dec 2011
Primary completion: May 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 30 Dec 2011 (estimated)
Results: Posted 17 Feb 2016

Clinical summary

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

Detailed description

This study aims to:

Evaluate the antidepressant effect and safety of rTMS in adolescents meeting criteria for major depressive disorder, single or recurrent episode.
Evaluate, by proton magnetic resonance spectroscopy (1H-MRS) at 3 Tesla (3T), the regional specificity [anterior cingulate (AC) vs. left dorsolateral prefrontal cortex (L-DLPFC)] of cerebral metabolites (glutamate and glutamine) in adolescent depression and study whether glutamine resonances are associated with response or remission of clinical depressive symptoms when rTMS is used to treat adolescent depression.
Evaluate the accuracy of an efficient method for locating the F3 position (i.e., L-DLPFC) through comparison with magnetic resonance imaging (MRI).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Transcranial Magnetic Stimulation	Experimental	Device: Transcranial Magnetic StimulationOpen-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.

Who may qualify

Ages: 13 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (17 listed)

Diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features
Pretreatment CDRS-R Raw score ≥ 40
Age is at least 13 and less than 19 years
Ongoing, stable dose antidepressant therapy for at least 6 weeks to include the following antidepressants (with dosing range):
Subjects able to attend at least 31 study visits at Mayo Clinic - Rochester

Key exclusion criteria (8 listed)

Subjects currently on stimulant, antipsychotic, bupropion or tricyclic antidepressant medications.
Prior rTMS, vagus nerve stimulation (VNS) or electroconvulsive therapy (ECT)
Contraindication to MRI
Contraindication to rTMS (history of neurological disorder such as seizures, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for >15 minutes, history of stroke, family history of epilepsy, intracardiac lines, Anticoagulant, immune suppressive and/or chemotherapy, or those who received any of these therapies within 3 months before enrollment in the study Unstable medication conditions such as hematological or infectious (e.g., human immunodeficiency virus-HIV) disorders, implanted electronic device, metal in the head, or pregnancy)
History of schizophrenia, schizoaffective disorder, other [non mood disorder] psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), bipolar disorder, psychotic features in this or previous episodes, amnestic disorder, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder

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
Transcranial Magnetic StimulationAlso: NeuroStar30 daily treatments of (over 6-8 weeks) of 10 Hz rTMS at 120% motor threshold, applied to the left dorsolateral prefrontal cortex with 3,000 stimulations per treatment	Device	Transcranial Magnetic Stimulation

Primary outcome

Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)
Time frame: 5 days of Treatment 30 or Last Treatment
The Children's Depression Rating Scale-Revised (CDRS-R) is a validated, 17-item, semi-structured clinician rating tool to assess severity of depression with subject and parental input for 14 of the 17 items.

2 secondary outcomes

Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)
Time frame: Within 5 days of Treatment 30 or Last Treatment
The Clinical Global Impression - Improvement (CGI-I)
Time frame: Within 5 days of 30 treatments or after last treatment in case of early withdrawal

Results and safety

Results posted to the registry on 17 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Transcranial Magnetic Stimulation	10	7

Primary outcome: Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)

Time frame: 5 days of Treatment 30 or Last Treatment. Mean (Standard Deviation). Unit: units on a scale

Measure	Transcranial Magnetic Stimulation n = 10
Value	41.8 (13.2)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open Label Active Treatment	0 of 10 (0%)	3 of 10 (30%)	Not reported

Limitations and caveats (from the sponsor): Please note that clinical results must be interpreted with caution due to small sample size and study design.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24376426Wall CA, Croarkin PE, McClintock SM, Murphy LL, Bandel LA, Sim LA, Sampson SM. Neurocognitive effects of repetitive transcranial magnetic stimulation in adolescents with major depressive disorder. Front Psychiatry. 2013 Dec 12;4:165. doi: 10.3389/fpsyt.2013.00165. eCollection 2013.
Derived from this study: PubMed 31634515Sonmez AI, Kucuker MU, Lewis CP, Kolla BP, Doruk Camsari D, Vande Voort JL, Schak KM, Kung S, Croarkin PE. Improvement in hypersomnia with high frequency repetitive transcranial magnetic stimulation in depressed adolescents: Preliminary evidence from an open-label study. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Mar 8;97:109763. doi: 10.1016/j.pnpbp.2019.109763. Epub 2019 Oct 18.
Derived from this study: PubMed 26849202Wall CA, Croarkin PE, Maroney-Smith MJ, Haugen LM, Baruth JM, Frye MA, Sampson SM, Port JD. Magnetic Resonance Imaging-Guided, Open-Label, High-Frequency Repetitive Transcranial Magnetic Stimulation for Adolescents with Major Depressive Disorder. J Child Adolesc Psychopharmacol. 2016 Sep;26(7):582-9. doi: 10.1089/cap.2015.0217. Epub 2016 Feb 5.
Individual participant dataSharing planned: No

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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.

Paul E Croarkin, DO 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 Transcranial Magnetic Stimulation in people with Major Depressive Disorder, run by Paul E. Croarkin 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 17 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 22 Apr 2016. 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 17 Feb 2016). 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?

Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal) (time frame: 5 days of Treatment 30 or Last Treatment). 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 NCT01502033, which also lists 3 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 22 Apr 2016.