Depression
Conditions
Keywords
Depression, rTMS
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.
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation (rTMS)
Active 10 Hz rTMS will be applied to the left dorsolateral prefrontal cortex (L-DLPFC) with an intensity of 120% motor threshold. The L-DLPFC location is defined as that area 5 cm anterior to the motor cortex for activation of abductor pollicis brevis. Subjects will receive a total of 3000 stimuli per session. The TMS trains are 4 seconds on and 26 seconds off for a total of 37 1/2 minutes. Treatment will occur 5 days per week for up to six weeks. Subjects will be monitored during rTMS for any side effects or adverse events.
Sponsors
Neuronetics
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Repetitive Transcranial Magnetic Stimulation 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. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Repetitive Transcranial Magnetic Stimulation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Change in Hamilton Rating Scale for Depression (HRS-D17)
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.
Time frame: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks
Population: This study was stopped early due to funding constraints and recruitment was slower than was expected.
Secondary
Change in Quick Inventory of Depressive Symptoms - Clinician Rating 16 Item (QIDS-C16)
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
Time frame: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks
Population: This study was stopped early due to funding constraints and recruitment was slower than was expected.