Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens
Status: | Completed |
---|---|
Conditions: | Depression, Major Depression Disorder (MDD) |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 13 - 18 |
Updated: | 4/21/2016 |
Start Date: | December 2011 |
End Date: | December 2013 |
An Open-Label Eight-Week Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents: Mechanisms of Response
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.
magnetic stimulation (rTMS) on teens with depression. The study also seeks to understand how
rTMS treatment affects the neurobiology of teens with depression.
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).
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).
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
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