Clinical trial NCT01115699: Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as Adjuvant Treatment for Depression
Official title: Pilot Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as Adjuvant Treatment in Patients With Non-remitting Depression: Third Stage of Citalopram/Escitalopram Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Keywords: Depression
rTMS
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Neuronetics
First posted: 2010-05-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will systematically investigate the use of repetitive transcranial magnetic stimulation (rTMS) in non-remitters of a selective serotonin reuptake inhibitor (SSRI) followed by a serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to identify gene variants that predict rTMS response.

Detailed description: This is the first study of its kind to systematically investigate the use of repetitive transcranial magnetic stimulation (rTMS) in non-remitters of a selective serotonin-reuptake inhibitor (SSRI) followed by an serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to identify gene variants that predict rTMS response. The study is similar in design to the STAR\*D study in that it will be the third treatment stage for a study of subjects with major depressive disorder (MDD). rTMS is a novel intervention which was FDA approved for treatment of MDD in October 2008 and was not clinically available at the time of the STAR\*D study.

The primary aim of this pilot study is to provide 10 Hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) as adjuvant treatment for depression in individuals who have not had a remission of their depressive symptoms after an 8 week trial of an SSRI (citalopram or escitalopram) followed by an 8 week trial of an SNRI, duloxetine and identify gene variants associated with improvement of their depressive symptoms.

Eligibility criteria: Inclusion Criteria

* Subjects whose depressive symptoms have not remitted during their participation in the "Pharmacokinetics and Pharmacodynamics of Citalopram and Escitalopram" study or the "Pharmacokinetics and Pharmacodynamics of Duloxetine" study
* Must be able to continue to take same dose of duloxetine through the course of the study

Exclusion Criteria

* A history of failure for respond to Electroconvulsive Therapy (ECT)
* Any metal in the head (except in mouth)
* Implanted medication pump or cardiac pacemaker
* Have had prior brain surgery
* Have unprovoked seizure disorder or family history of treatment resistant epilepsy
* Pregnancy
* Psychiatric hospitalization within the past two weeks
* Suicide attempt with hospitalization within past three months

Primary outcomes:
measure: Change in Hamilton Rating Scale for Depression (HRS-D17)
timeFrame: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks
Secondary outcomes:
measure: Change in Quick Inventory of Depressive Symptoms - Clinician Rating 16 Item (QIDS-C16)
timeFrame: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Mrazek, MD
role: PRINCIPAL_INVESTIGATOR
References: