High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Major Depression

Depression Clinical Trial

Official title:

A Randomized Sham-Controlled Study of High- and Low-frequency Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex in Major Depressive Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02702154
• Other study ID #: 15-9276-A
• Status: Active, not recruiting
• Phase: N/A
• First received: March 2, 2016
• Last updated: March 29, 2018
• Start date: February 2016
• Est. completion date: August 2018

Study information

• Verified date: March 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered twice daily over 15 days, in patients with a diagnosis of major depressive disorder. The trial will include structural and functional MRI, EEG, and behavioral measures obtained before, during, and after treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: August 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria (Patient):

• Voluntary and competent to consent to treatment

• MINI confirmed diagnosis of MDD

• Outpatient

• Between the ages of 18-65

• Failed to achieve a clinical response to at least one pharmacotherapy or behavioral treatment in the current episode.

• Have had no increase or initiation of any psychotropic medication in the last 4 weeks prior to screening

• Must adhere to study assessment and intervention schedule.

• Pass the TMS Safety Screening Questionnaire.

Exclusion Criteria (Patient):

• Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical pump

• Have active suicidal intent

• Are pregnant

• Have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms have a MINI diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than MDD

• Have received rTMS for any previous indication due to the potential compromise of subject blinding.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• High-frequency rTMS
20 Hz active stimulation, twice daily
• Low-frequency rTMS
1 Hz active stimulation, twice daily
• Sham rTMS
Sham stimulation, twice daily

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resting-state functional MRI	10 min resting-state functional MRI acquisition at 3T	1 week pre- and 1 week post-intervention
Other	Electroencephalography	10 min resting-state and task-based (response inhibition, reward sensitivity) acquisitions	Day 1 and day 15 (final day) of rTMS intervention
Primary	HAM-D17 score	Outcome measured by a change in HAM-D17 score from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of <8 is categorized as remission.	Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Secondary	Beck Depression Inventory-II		Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Secondary	Beck anxiety inventory		Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment