NCT02184221

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

June 30, 2014

Last Update Submit

August 30, 2017

Conditions

Major Depressive Disorder

Keywords

Deep-brain magnetic stimulationBrain derived neurotropic factorEffectivenessSafety

Outcome Measures

Primary Outcomes (1)

  • Improvement of Depression

    the Change of 17-item Hamilton Depression Scale (HAMD-17) total score

    From randomization to endpoint(Week 6)

Secondary Outcomes (5)

  • Improvement of Anxiety

    From randomization to endpoint (Week 6)

  • Remission rate

    From randomization to endpoint (Week 6)

  • Response rate

    From randomization to endpoint (Week 6)

  • Safety outcome 1

    From enrollment to endpoint (Week 6)

  • Safety outcome 2

    From randomization to endpoint (Week 6)

Other Outcomes (1)

  • BDNF change

    From randomization to endpoint (Week 6)

Study Arms (2)

High frequency stimulation

EXPERIMENTAL

alpha burst, 8\~12Hz, run 2 seconds, rest 8 seconds, lasts 20 minutes each time

Device: High frequency stimulation

Low frequency stimulation

ACTIVE COMPARATOR

0.5Hz, run 0.5 seconds, rest 1.5 seconds, lasts 20 minutes each time

Device: Low frequency stimulation

Interventions

High frequency stimulationDEVICE

The parameter of DMS: alpha frequency

Also known as: Alpha frequency stimulation
High frequency stimulation
Low frequency stimulationDEVICE

The parameter of DMS: 0.5Hz

Also known as: 0.5Hz stimulation
Low frequency stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anding Hospital

Beijing, Beijing Municipality, 100088, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Gang Wang, M.D., Ph.D

    Beijing Anding Hospital, Capital Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Depression Center, Vice-principal of

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 9, 2014

Study Start

May 1, 2010

Primary Completion

January 1, 2011

Study Completion

April 1, 2011

Last Updated

August 31, 2017

Record last verified: 2017-08

Locations

CN(1)