N/A
N=8
An Evaluation of Safety and Feasibility Using Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00587639 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2) — -11.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- rTMS Treatment (Device)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2) |
-11.3 | — |
| SECONDARY Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R) |
33.3 | — |
Summary
The objective of this investigation is to examine the safety and feasibility of a series of repetitive transcranial magnetic stimulation (rTMS) treatments (10 Hertz [Hz]; Left Dorsolateral Prefrontal Cortex), with a Neuronetics Model 2100 Therapy System as adjuvant treatment for depression in adolescent subjects.
Eligibility Criteria
Inclusion Criteria
- Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of unipolar major depression without psychosis.
- Current or past history of lack of response to at least two adequate antidepressant trials selective serotonin re-uptake inhibitors (SSRI) operationally defined using the Antidepressant Treatment History Form (ATHF)
- Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or higher at baseline
- At least six weeks of ongoing SSRI therapy at a stable dose.
- SSRI Medications will include:
- Citalopram (Celexa, Cipramil, Emocal, Sepram)
- Escitalopram oxalate (Lexapro, Cipralex, Esertia)
- Fluoxetine (Prozac, Fontex, Seromex, Seronil, Sarafem, Fluctin (EUR))
- Fluvoxamine maleate (Luvox, Faverin)
- Paroxetine (Paxil, Seroxat, Aropax, Deroxat)
- Sertraline (Zoloft, Lustral, Serlain)
- Age 13-18 years.
- Outpatient, inpatient, or partial hospitalization patients.
- Capable of providing informed assent/consent (in addition to parent/guardian consent).
Exclusion Criteria
- Current Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, mental retardation, pervasive developmental disorder, somatoform disorder, dissociative disorder, posttraumatic stress disorder, obsessive-compulsive disorder, eating disorders, antecedents of autism, and all personality disorders.
- Active substance dependence (except nicotine) in the past 12 months.
- Subjects with a history of head trauma, unprovoked seizure history, seizure disorder, or family history of treatment resistant epilepsy.
- Suspected pregnancy or pregnancy as confirmed by a urine pregnancy test at screening.
- History of failure to respond to ECT.
- Metal in the head (except in the mouth), implanted medication pump, cardiac pacemaker.
- Prior brain surgery.
- Risk for increased intracranial pressure such as brain tumor.
- Unable to obtain motor threshold in the subject or motor threshold too high, such that 120% MT cannot be obtained (i.e. >84% of device output).
- Significant change or increase in antidepressant medications within the last six weeks.
- Change in psychiatrist, psychologist, or therapist within the last four weeks.
- Suicide attempt within the past three months.
- Any suicide attempt or suicidal intent during the study will terminate involvement in this study.
- Subjects currently on stimulant, antipsychotic, atypical antidepressant or tricyclic antidepressant medications.
- Unstable medical or neurological conditions that may include hematological, infectious (such as Human immunodeficiency virus [HIV] positive patients) metabolic, or cardiovascular conditions that may preclude safe participation in trial.
- Subjects undergoing anticoagulant, immune suppressive and 1 or chemotherapy, or those who received any of these therapies </=3 months before enrollment in the study
- Subjects with intra-cardiac lines
Data sourced from ClinicalTrials.gov (NCT00587639). 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.