Back to resultsDeep-brain Magnetic Stimulation (DMS) in the Treatment of Major Depressive Disorder (DTMS)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High frequency stimulation
Low frequency stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Deep-brain magnetic stimulation, Brain derived neurotropic factor, Effectiveness, Safety
Eligibility Criteria
Inclusion Criteria:
- Has given written informed consent.
- Aged from 18 to 60 years old.
- Has a diagnosis of major depressive disorder by DSM-IV criteria.
- HAMD-17 ≥ 18.
- Right-handed.
- Be drug free at least 30 days at randomization.
Exclusion Criteria:
- Current Axis I primary psychiatric diagnosis other than major depressive disorder.
- Organic mental disease, including mental retardation.
- History of clinically significant disease, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require treatment during the study.
- Subjects receiving an investigational agent (including different formulation and generic agents of investigational drug) in the previous 3 months prior to screening.
- Women in pregnancy or lactation, or female of child bearing potential without appropriate birth control measures.
- Has received ECT or MECT within 3 months prior to screening.
- Significant risk of suicidal and/or self-harm behaviors.
Sites / Locations
- Beijing Anding Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High frequency stimulation
Low frequency stimulation
Arm Description
alpha burst, 8~12Hz, run 2 seconds, rest 8 seconds, lasts 20 minutes each time
0.5Hz, run 0.5 seconds, rest 1.5 seconds, lasts 20 minutes each time
Outcomes
Primary Outcome Measures
Improvement of Depression
the Change of 17-item Hamilton Depression Scale (HAMD-17) total score
Secondary Outcome Measures
Improvement of Anxiety
the Change of Hamilton Anxiety Scale (HAMA) total score
Remission rate
The proportion of subjects at endpoint with HAMD-17≤7
Response rate
The proportion of subjects at endpoint with the reduction of HAMD-17 total score>=50%
Safety outcome 1
The incidence and nature of adverse events
Safety outcome 2
The number of subject withdrawal due to adverse events
Full Information
NCT ID
NCT02184221
First Posted
June 30, 2014
Last Updated
August 30, 2017
Sponsor
Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02184221
Brief Title
Deep-brain Magnetic Stimulation (DMS) in the Treatment of Major Depressive Disorder
Acronym
DTMS
Official Title
The Effectiveness of Deep-brain Magnetic Stimulation in the Treatment of Major Depressive Disorder：a Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Transcranial magnetic stimulation (TMS) is an effective alternative for pharmacotherapy in major depressive disorder, but the effectiveness is not clear due to stimulated region, frequency and intensity of magnet field. Standard TMS techniques only can stimulate superficial cortical areas as the electric field decreases rapidly as a function of tissue depth，while depression is also interconnected with deeper neuronal regions. Deep-brain magnetic stimulation (DSM, or deep TMS, DTMS) allows stimulation of deeper cortical regions. Previous research has demonstrated that alpha frequency (8-13 Hz) EEG activity may have particular relevance to the response to antidepressants, and reduction of alpha frequency (8-13 Hz) could lead to negative symptoms. It has been reported that both alpha frequency and low-field magnetic stimulation could improve depressive symptoms.
The objective of this study is to compare the effectiveness of the two different parameters of DMS in the treatment of major depressive disorder. The changes of brain derived neurotropic factor (BDNF) are also investigated to make a relevant analysis of the improvement of depressive symptoms.
Detailed Description
The study is designed as randomized, double-blinded, active-controlled trial in major depressive disorder.
Patients will be male or female, 18 to 60 years of age, right-handed, outpatient or inpatient status, with diagnosis of major depressive episode (single or recurrent) by DSM-IV. The HAMD-17 total score is no less than 18 at enrollment. The patients should be drug free at least 30 days before entering the trial. The eligible patients are randomized to one of the two treatment groups using a 1:1 ratio for the alpha frequency (high frequency) and 0.5Hz (low frequency) groups.
Throughout the course of the study, DMS sessions are administered by trained physicians for 20 minutes at a time, with 5 sessions per week, during 6 consecutive weeks. Raters who are blinded to the treatment arm perform evaluations. The effective outcome is assessed by the HAMD-17 and HAMA every two weeks including randomization. Serum BDNF level are also tested at each visits (Week 0, 2, 4 and 6). The safety in this study will be assessed by adverse event reporting, clinical laboratory measurements and physical examinations.
Primary efficacy measure will be assessed based on the decrease of HAMD-17 from randomization to endpoint (Week 6).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Deep-brain magnetic stimulation, Brain derived neurotropic factor, Effectiveness, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High frequency stimulation
Arm Type
Experimental
Arm Description
alpha burst, 8~12Hz, run 2 seconds, rest 8 seconds, lasts 20 minutes each time
Arm Title
Low frequency stimulation
Arm Type
Active Comparator
Arm Description
0.5Hz, run 0.5 seconds, rest 1.5 seconds, lasts 20 minutes each time
Intervention Type
Device
Intervention Name(s)
High frequency stimulation
Other Intervention Name(s)
Alpha frequency stimulation
Intervention Description
The parameter of DMS: alpha frequency
Intervention Type
Device
Intervention Name(s)
Low frequency stimulation
Other Intervention Name(s)
0.5Hz stimulation
Intervention Description
The parameter of DMS: 0.5Hz
Primary Outcome Measure Information:
Title
Improvement of Depression
Description
the Change of 17-item Hamilton Depression Scale (HAMD-17) total score
Time Frame
From randomization to endpoint(Week 6)
Secondary Outcome Measure Information:
Title
Improvement of Anxiety
Description
the Change of Hamilton Anxiety Scale (HAMA) total score
Time Frame
From randomization to endpoint (Week 6)
Title
Remission rate
Description
The proportion of subjects at endpoint with HAMD-17≤7
Time Frame
From randomization to endpoint (Week 6)
Title
Response rate
Description
The proportion of subjects at endpoint with the reduction of HAMD-17 total score>=50%
Time Frame
From randomization to endpoint (Week 6)
Title
Safety outcome 1
Description
The incidence and nature of adverse events
Time Frame
From enrollment to endpoint (Week 6)
Title
Safety outcome 2
Description
The number of subject withdrawal due to adverse events
Time Frame
From randomization to endpoint (Week 6)
Other Pre-specified Outcome Measures:
Title
BDNF change
Description
Change of serum BDNF level
Time Frame
From randomization to endpoint (Week 6)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has given written informed consent.
Aged from 18 to 60 years old.
Has a diagnosis of major depressive disorder by DSM-IV criteria.
HAMD-17 ≥ 18.
Right-handed.
Be drug free at least 30 days at randomization.
Exclusion Criteria:
Current Axis I primary psychiatric diagnosis other than major depressive disorder.
Organic mental disease, including mental retardation.
History of clinically significant disease, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require treatment during the study.
Subjects receiving an investigational agent (including different formulation and generic agents of investigational drug) in the previous 3 months prior to screening.
Women in pregnancy or lactation, or female of child bearing potential without appropriate birth control measures.
Has received ECT or MECT within 3 months prior to screening.
Significant risk of suicidal and/or self-harm behaviors.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Wang, M.D., Ph.D
Organizational Affiliation
Beijing Anding Hospital, Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anding Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100088
Country
China
12. IPD Sharing Statement
Learn more about this trial
Deep-brain Magnetic Stimulation (DMS) in the Treatment of Major Depressive Disorder
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