Accelerated Transcranial Magnetic Stimulation (aTBS) to Treat Depression

NCT03941106 | Completed

• 1 other identifier: CNIG18may-0001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

The primary aims of this study are to investigate the efficacy of L DLPFC accelerated TMS (aTMS) in patients with depression in Singapore and to assess the whether a 1-week course of treatment is as effective as a 4-week course of non-accelerated treatment and if additional aTMS or different aTMS treatments will be more efficacious in non-responders to initial aTMS treatment.

Conditions

Depression

Keywords

rTMS, depression, accelerated

Outcome Measures

Primary Outcomes (1)

• Remission as assessed by The Montgomery-Åsberg Depression Rating Scale (MADRS)

  The MADRS is a 0-60 point scale to measure depression severity with a higher number indicating more severe depression. Remission from depression is defined as 10 or less. Moderate to severe depression is defined as 20 or more.

  3 weeks

Secondary Outcomes (1)

• Remission as assessed by The Montgomery-Åsberg Depression Rating Scale (MADRS)

  6 weeks

Study Arms (2)

Left aTMS

EXPERIMENTAL

Device: Accelerated repetitive transcranial magnetic stimulation

Right aTMS

EXPERIMENTAL

Device: Accelerated repetitive transcranial magnetic stimulation

Interventions

Accelerated repetitive transcranial magnetic stimulation DEVICE

Subjects will be given accelerated left sided rTMS and randomized to more of the same accelerated rTMS if not meeting remission criteria for depression or a different type of rTMS on the right side

Left aTMS; Right aTMS

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥21 years.
• DSM-V diagnosis of current Major Depressive Episode.
• Montgomery-Asberg Depression Rating Scale score of 20 or more.
• Able to give informed consent.

You may not qualify if:

• DSM-V psychotic disorder.
• Drug or alcohol abuse or dependence (preceding 3 months).
• Inadequate response to ECT (current episode of depression).
• Rapid clinical response required, e.g. high suicide risk.
• Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
• Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.
• Pregnancy.

Sponsors & Collaborators

• Institute of Mental Health, Singapore: lead

Study Sites (2)

Institute of Mental Health

Singapore, 539747, Singapore

Location

Institute of Mental Health

Singapore, Singapore

Location

Related Publications (2)

• Tor PC, Galvez V, Goldstein J, George D, Loo CK. Pilot Study of Accelerated Low-Frequency Right-Sided Transcranial Magnetic Stimulation for Treatment-Resistant Depression. J ECT. 2016 Sep;32(3):180-2. doi: 10.1097/YCT.0000000000000306.

  PMID: 26909825 BACKGROUND

• Tan XW, Abdin E, Tor PC. Accelerated transcranial magnetic stimulation (aTMS) to treat depression with treatment switching: study protocol of a pilot, randomized, delayed-start trial. Pilot Feasibility Stud. 2021 May 5;7(1):104. doi: 10.1186/s40814-021-00845-9.

  PMID: 33952345 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2019
• First Posted: May 7, 2019
• Study Start: July 1, 2019
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 1, 2023

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)