Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 11-004500
NCT ID: NCT01502033
Sponsor Protocol Number: 11-004500
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
This study has been completed
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
- 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
- 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
- vascular disorder.
- Unstable cardiac disease, uncontrolled hypertension, or sleep apnea
- Active suicidal intent or plan, or history of attempt within the past 6 months
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Paul Croarkin, D.O., M.S. |
Closed for enrollment |
|
More information
Publications
-
It is estimated that 30-40% of adolescents with major depressive disorder (MDD) do not receive full benefit from current antidepressant therapies. Repetitive transcranial magnetic stimulation (rTMS) is a novel therapy approved by the US Food and Drug Administration to treat adults with MDD. Research suggests rTMS is not associated with adverse neurocognitive effects in adult populations; however, there is no documentation of its neurocognitive effects in adolescents. This is a secondary post hoc analysis of neurocognitive outcome in adolescents who were treated with open-label rTMS in two separate studies.
Read More on PubMed