N/A
Completed N=10
Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens
Source: ClinicalTrials.gov NCT01502033 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal) — 41.8 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal) |
41.8 | — |
| SECONDARY Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal) |
3.4 | — |
| SECONDARY The Clinical Global Impression - Improvement (CGI-I) |
2.7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01502033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.