Ignite Creation Date:
2024-05-06 @ 3:01 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02184221
Status:
COMPLETED
Last Update Posted:
2017-08-31
First Post:
2014-06-30
Brief Title:
Deep-brain Magnetic Stimulation DMS in the Treatment of Major Depressive Disorder
Sponsor:
Capital Medical University
Organization:
Capital Medical University
Study Overview
Official Title:
The Effectiveness of Deep-brain Magnetic Stimulation in the Treatment of Major Depressive Disordera Preliminary Study
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DTMS
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 depthwhile 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
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 11 ratio for the alpha frequency high frequency and 05Hz 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
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 11 ratio for the alpha frequency high frequency and 05Hz 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None