Pilot Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as Adjuvant Treatment in Patients With Non-remitting Depression: Third Stage of Citalopram/Escitalopram Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Mayo Clinic
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Change in Hamilton Rating Scale for Depression (HRS-D17)
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
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.
Investigators
David Mrazek
David Mrazek, M.D.
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Hamilton Rating Scale for Depression (HRS-D17)
Time Frame: 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 Outcomes
- 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)