- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02184221
Deep-brain Magnetic Stimulation (DMS) in the Treatment of Major Depressive Disorder (DTMS)
The Effectiveness of Deep-brain Magnetic Stimulation in the Treatment of Major Depressive Disorder:a Preliminary Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100088
- Beijing Anding Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High frequency stimulation
alpha burst, 8~12Hz, run 2 seconds, rest 8 seconds, lasts 20 minutes each time
|
The parameter of DMS: alpha frequency
Other Names:
|
ACTIVE_COMPARATOR: Low frequency stimulation
0.5Hz, run 0.5 seconds, rest 1.5 seconds, lasts 20 minutes each time
|
The parameter of DMS: 0.5Hz
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of Depression
Time Frame: From randomization to endpoint(Week 6)
|
the Change of 17-item Hamilton Depression Scale (HAMD-17) total score
|
From randomization to endpoint(Week 6)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of Anxiety
Time Frame: From randomization to endpoint (Week 6)
|
the Change of Hamilton Anxiety Scale (HAMA) total score
|
From randomization to endpoint (Week 6)
|
Remission rate
Time Frame: From randomization to endpoint (Week 6)
|
The proportion of subjects at endpoint with HAMD-17≤7
|
From randomization to endpoint (Week 6)
|
Response rate
Time Frame: From randomization to endpoint (Week 6)
|
The proportion of subjects at endpoint with the reduction of HAMD-17 total score>=50%
|
From randomization to endpoint (Week 6)
|
Safety outcome 1
Time Frame: From enrollment to endpoint (Week 6)
|
The incidence and nature of adverse events
|
From enrollment to endpoint (Week 6)
|
Safety outcome 2
Time Frame: From randomization to endpoint (Week 6)
|
The number of subject withdrawal due to adverse events
|
From randomization to endpoint (Week 6)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BDNF change
Time Frame: From randomization to endpoint (Week 6)
|
Change of serum BDNF level
|
From randomization to endpoint (Week 6)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMS-2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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