Accelerated rTMS for Treatment-Resistant Major Depression

Major Depressive Disorder Clinical Trial

Official title:

A Pilot Trial on the Effectiveness and Tolerability of Accelerated High Frequency Repetitive Transcranial Magnetic Stimulation for Treating Resistant Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125799
• Other study ID #: ERB12/38
• Secondary ID: IRB12/38
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 25, 2014
• Last updated: October 2, 2014
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Douglas Mental Health University Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has shown safety and efficacy for treatment-resistant depression, but requires daily treatment for 4-6 weeks. Accelerated HF-TMS (aHF-rTMS), in which all treatments are delivered in less time, would have significant advantages in terms of access, patient acceptance and costs. In the present open label trial the investigators intend to assess the effectiveness and acceptability of a novel aHF-rTMS protocol (i.e., 2 daily sessions over 2 consecutive weeks; 6,000 pulses per day). For this, depressed outpatients will receive the aHF-rTMS protocol and will be assessed at baseline and at weeks 3 and 9 with several clinician- and patient- reported measures as well as with computerized neurocognitive tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Presence of a current major depressive disorder (according to the DSM-IV-TR) that has not improved after = 2 adequate antidepressant trial(s) in the current episode;

• Baseline score = 13 on the QIDS-C

• Stable medication regimen (>= 4 weeks) prior to study enrolment

Exclusion Criteria:

• Psychotic features in the current episode

• Lifetime history of psychotic disorders and/or bipolar I or II disorders

• Substance or alcohol abuse/dependence in the past 6 months

• Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)

• Uncontrolled medical disease (e.g., cardiovascular, renal)

• Pregnancy and/or lactation

• Presence of a specific contraindication for rTMS (e.g., personal history of epilepsy, metallic head implant)

• Hearing loss

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Accelerated HF-rTMS (Magstim Rapid 2 stimulator)
Twice daily rTMS sessions involving 10 Hz in 75 trains of 4 seconds duration, with 26 seconds intertrain intervals (6,000 pulses per day) at 120% of the resting motor threshold.

Locations

Country	Name	City	State
Canada	Douglas Mental Health University Institute	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Douglas Mental Health University Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quick Inventory of Depressive Symptomatology - Clinician Version	Response to treatment is defined as a = 50% reduction in the scores of the QIDS-C. Remission is defined as a QIDS-C score = 5.	Week 3	No