rTMS for Depressed Teens: A Sham-Controlled Trial, Part 2

Major Depressive Disorder Clinical Trial

Official title:

A Randomized, Double-Blinded, Sham-Controlled Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01804296
• Other study ID #: 12-003248 Part 2
• Status: Terminated
• Phase: N/A
• Start date: March 2013
• Est. completion date: September 2015

Study information

• Verified date: December 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research proposal aims to better understand the neurobiology of depression in adolescents and how repetitive transcranial magnetic stimulation (rTMS) may therapeutically impact brain function and mood. This investigation also proposes the first study to examine the efficacy of rTMS maintenance therapy in adolescents who have met clinical criteria following acute rTMS treatment. The magnetic resonance (MR) spectroscopy pattern of rTMS response will be analyzed according to previously established protocols.

Description:

Part 2 of the study aims to:

• Evaluate the benefit of daily, active, open-label rTMS in Part 1 non-responders.

• Evaluate the benefits of bi-weekly, active, open-label maintenance rTMS treatment for Part 1 responders over the course of 12 months post acute treatment.

• Evaluate, by proton magnetic resonance spectroscopy (1H-MRS) at 3 Tesla(3T), neurometabolic biomarkers at the beginning and end of each study phase.

• Define regional specificity [anterior cingulate (AC) and left dorsolateral prefrontal cortex (L-DLPFC)] of cerebral metabolites (i.e. glutamate and glutamine) in adolescent depression.

• Study whether specific neurochemical resonances are associated with response, remission, and/or maintenance of improvement of clinical depressive symptoms when rTMS is used to treat adolescent depression.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

Inclusion Criteria:

• Successful completion of Part 1 of study

• Diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features

• Age is at least 12 and less than 22 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

• Savella (milnacipran HCl) - 25mg to 200mg

• Zoloft (sertraline HCl) - 25mg to 200mg

• Subjects able to attend all study visits at study site.

• Willing to provide informed assent (adolescent) and informed consent (family)

Exclusion Criteria:

• Withdrew from treatment of study Part 1

• Subjects currently on stimulant, antipsychotic, bupropion or tricyclic antidepressant medications.

• Prior 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

Related Conditions & MeSH terms

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

Intervention

Device:
• Repetitive transcranial magnetic stimulation (rTMS)
Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Paul E. Croarkin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in the Case 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.	Within 5 days after Treatment 30 or Last Treatment
Primary	Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in the Case of Early Withdrawal)	The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a 7-point scale with which the clinician rates the severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis.	Within 5 days after Treatment 30 or Last Treatment
Primary	Mean Clinical Global Impression - Improvement (CGI-I) Score Post Treatment 30 or Last Treatment (in the Case of Early Withdrawal)	The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates the degree to which the severity of the subject's depressive illness has improved or worsened compared to baseline severity.	Within 5 days after Treatment 30 or Last Treatment

External Links

•   Mayo Clinic Clinical Trials