Status:
TERMINATED
rTMS for Depressed Teens: A Sham-Controlled Trial, Part 2
Lead Sponsor:
Paul E. Croarkin
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
12-21 years
Phase:
NA
Brief 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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01804296
Start Date
March 1 2013
End Date
September 1 2015
Last Update
January 19 2022
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425