Major Depressive Disorder Clinical Trial
— DTMSOfficial title:
The Effectiveness of Deep-brain Magnetic Stimulation in the Treatment of Major Depressive Disorder:a Preliminary Study
Verified date | August 2017 |
Source | Capital Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | April 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Anding Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Capital Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | BDNF change | Change of serum BDNF level | From randomization to endpoint (Week 6) | |
Primary | Improvement of Depression | the Change of 17-item Hamilton Depression Scale (HAMD-17) total score | From randomization to endpoint(Week 6) | |
Secondary | Improvement of Anxiety | the Change of Hamilton Anxiety Scale (HAMA) total score | From randomization to endpoint (Week 6) | |
Secondary | Remission rate | The proportion of subjects at endpoint with HAMD-17=7 | From randomization to endpoint (Week 6) | |
Secondary | Response rate | The proportion of subjects at endpoint with the reduction of HAMD-17 total score>=50% | From randomization to endpoint (Week 6) | |
Secondary | Safety outcome 1 | The incidence and nature of adverse events | From enrollment to endpoint (Week 6) | |
Secondary | Safety outcome 2 | The number of subject withdrawal due to adverse events | From randomization to endpoint (Week 6) |
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