Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as Adjuvant Treatment for Depression

Not Applicable

Terminated

• Conditions: Depression
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

• Registration Number: NCT01115699
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-30
• Study First Submitted QC: 2010-04-30
• Study First Posted: 2010-05-04
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-10
• Results First Submitted: 2013-10-23
• Results First Submitted QC: 2013-10-23
• Last Update Submitted: 2013-10-23
• Results First Posted: 2013-12-13
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Repetitive Transcranial Magnetic Stimulation	Repetitive Transcranial Magnetic Stimulation (rTMS)	All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Hamilton Rating Scale for Depression (HRS-D17)	baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks	The HRS-D17 questionnaire has 17 items. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.

Secondary Outcome Measures

Name	Time	Method
Change in Quick Inventory of Depressive Symptoms - Clinician Rating 16 Item (QIDS-C16)	baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks	The QIDS-C16 measures 16 factors across 9 different criterion domains for major depression. Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following:the highest number from questions 1-4 + the number from question 5 + the highest number from questions 6-9 + the total of each question from 10-14 + the highest number from questions 15-16.; Screening test scoring ranges: * 0-5, No Depression Likely; * 6-10, Possibly Mildly Depressed; * 11-15, Moderate Depression; * 16-20, Severe Depression; * 21 or Over, Very Severe Depression

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States