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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502033
• Other study ID #: 11-004500
• Status: Completed
• Phase: N/A
• First received: December 27, 2011
• Last updated: January 20, 2016
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Description:

This study aims to:

1. Evaluate the antidepressant effect and safety of rTMS in adolescents meeting criteria for major depressive disorder, single or recurrent episode.

2. 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.

3. Evaluate the accuracy of an efficient method for locating the F3 position (i.e., L-DLPFC) through comparison with magnetic resonance imaging (MRI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

• 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)

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Transcranial Magnetic Stimulation
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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Paul E. Croarkin

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 days of Treatment 30 or Last Treatment	No
Secondary	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).	Within 5 days of Treatment 30 or Last Treatment	No
Secondary	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).	Within 5 days of 30 treatments or after last treatment in case of early withdrawal	No