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TBS Over DLPFC in Elderly Refractory Depression

Primary Purpose

Major Depression

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
TBS
sham
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 60 to 85 years
  • Major depression disorder
  • Under a stable dose of all psychotropic medication during the stimulation period.

Exclusion Criteria

  • Having any current psychiatric comorbidity or history of substance dependence.
  • Having active suicidal ideation currently.
  • Having severe physical illness, recent and/or current unstable medical disorders.
  • Having history of cancer or chemotherapy.
  • Dementia or MMSE<24.
  • Having TMS contraindicated (seizure disorder, history of seizures, metal in the head, pacemakers, history of craniotomy)

Sites / Locations

  • Department of Psychiatry, Kaohsiung Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental

Sham Comparator

Arm Description

We initially used cTBS (continuous TBS) over right DLPFC with 120-s train of uninterrupted bursts (1800 pulses) in each session per day. After that, we continuous use iTBS (intermittent TBS, iTBS) over left DLPFC with 2-s train of bursts was repeated every 10 s for a total of 570 s (1800 pulses).

Participants will receive sham (placebo) TBS treatment the same as experimental group

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale, HAM-D
The Ham-D is the most widely used clinician-administered depression assessment scale. The original version contains 17 items pertaining to symptoms of depression experienced over the past week. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.

Secondary Outcome Measures

Beck depression inventory, BDI-II
The BDI-II was a 1996 revision of the BDI. Participants were asked to rate how they have been feeling for the past two weeks. BDI-II also contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.
Beck anxiety inventory, BAI
The BAI, created by Aaron T. Beck and other colleagues, is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are as follows: 0-7: minimal anxiety; 8-15: mild anxiety; 16-25: moderate anxiety; 26-63: severe anxiety.

Full Information

First Posted
May 2, 2021
Last Updated
January 13, 2023
Sponsor
Kaohsiung Veterans General Hospital.
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1. Study Identification

Unique Protocol Identification Number
NCT04872465
Brief Title
TBS Over DLPFC in Elderly Refractory Depression
Official Title
Efficacy of Bilateral Dorsolateral Prefrontal Theta-burst Stimulation in Elderly Refractory Depression: a Randomized Sham-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study aim to examine the effect of Thea-burst stimulation over bilateral dorsolateral prefrontal cortex (DLPFC) among patients with LLD on mood condition and relevant biomarkers.
Detailed Description
Thea-burst stimulation (TBS) is a novel form of rTMS, providing greater modulation effect on neural activity. So far, no study was conducted to use TBS as treatment in LLD. Therefore, we aim to examine the effect of TBS over bilateral dorsolateral prefrontal cortex (DLPFC) among patients with LLD on mood condition and relevant biomarkers. The study used a two-arm, parallel, double-blind, randomized, and sham-controlled design. We plan to enroll sixty patients with LLD, thirty for active intervention and thirty for sham-controlled group. An Magstim Rapid2 stimulator with eight-figure coil was used for stimulation. Location of brain area are based on bilateral DLPFC. 3-pulse 50-Hz bursts was given every 200ms (at 5 Hz) and an intensity of 80% active motor threshold was settled. We initially used cTBS (continuous TBS) over right DLPFC with 120-s train of uninterrupted bursts (1800 pulses) in each session per day. After that, we continuous use iTBS (intermittent TBS, iTBS) over left DLPFC with 2-s train of bursts was repeated every 10 s for a total of 570 s (1800 pulses). Each patient received daily stimulation for two weeks with total ten sessions. The primary outcomes were change of depression severity including response and remission rate. Secondary outcome were biomarkers related to depression. Assessments were administered at baseline, immediately after 5 and 10 sessions of stimulation, and 3 months after the completion of stimulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Active Comparator
Arm Description
We initially used cTBS (continuous TBS) over right DLPFC with 120-s train of uninterrupted bursts (1800 pulses) in each session per day. After that, we continuous use iTBS (intermittent TBS, iTBS) over left DLPFC with 2-s train of bursts was repeated every 10 s for a total of 570 s (1800 pulses).
Arm Title
Sham Comparator
Arm Type
Placebo Comparator
Arm Description
Participants will receive sham (placebo) TBS treatment the same as experimental group
Intervention Type
Device
Intervention Name(s)
TBS
Intervention Description
We initially used cTBS (continuous TBS) over right DLPFC with 120-s train of uninterrupted bursts (1800 pulses) in each session per day. After that, we continuous use iTBS (intermittent TBS, iTBS) over left DLPFC with 2-s train of bursts was repeated every 10 s for a total of 570 s (1800 pulses).
Intervention Type
Device
Intervention Name(s)
sham
Intervention Description
Participants will receive sham (placebo) TBS treatment the same as experimental group
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale, HAM-D
Description
The Ham-D is the most widely used clinician-administered depression assessment scale. The original version contains 17 items pertaining to symptoms of depression experienced over the past week. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.
Time Frame
Change from baseline after 1, 2 weeks and three months
Secondary Outcome Measure Information:
Title
Beck depression inventory, BDI-II
Description
The BDI-II was a 1996 revision of the BDI. Participants were asked to rate how they have been feeling for the past two weeks. BDI-II also contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.
Time Frame
Change from baseline after 1, 2 weeks and three months
Title
Beck anxiety inventory, BAI
Description
The BAI, created by Aaron T. Beck and other colleagues, is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are as follows: 0-7: minimal anxiety; 8-15: mild anxiety; 16-25: moderate anxiety; 26-63: severe anxiety.
Time Frame
Change from baseline after 1, 2 weeks and three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 60 to 85 years Major depression disorder Under a stable dose of all psychotropic medication during the stimulation period. Exclusion Criteria Having any current psychiatric comorbidity or history of substance dependence. Having active suicidal ideation currently. Having severe physical illness, recent and/or current unstable medical disorders. Having history of cancer or chemotherapy. Dementia or MMSE<24. Having TMS contraindicated (seizure disorder, history of seizures, metal in the head, pacemakers, history of craniotomy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Che-Sheng Chu, MD
Phone
+886-7-3422121
Ext
72068
Email
cschu@vghks.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Che-Sheng Chu, MD
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Che-Sheng Chu, MD
Phone
+886-7-3422121
Ext
72068
Email
cschu@vghks.gov.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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TBS Over DLPFC in Elderly Refractory Depression

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