NCT03265340

Brief Summary

Aim: To test if there is a relation between deep Transcranial Magnetic Stimulation (dTMS) dose and clinical effect on Major Depressive Disorder (MDD) Method: 30 patients with moderate to severe MDD without concurrent medication will be randomised to three different treatment protocols of dTMS. Symptom severity of MDD will be quantified before, during and after dTMS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Sep 2014

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

September 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

October 28, 2016

Last Update Submit

March 11, 2019

Conditions

MAjor Depressive Disorder

Keywords

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • Montgomery Asberg Depression Rating Scale (MADRS) score

    MADRS baseline - MADRS last visit (treatment session 20)

    baseline to last visit (treatment session 20, an average of four weeks)

Secondary Outcomes (6)

  • Clinical Global Impression Severity (CGI-S)

    baseline to last visit (treatment session 20, an average of four weeks)

  • Montgomery Asberg Depression Rating Scale (MADRS) response

    last visit (treatment session 20, an average of four weeks)

  • Montgomery Asberg Depression Rating Scale (MADRS) remission

    last visit (treatment session 20, an average of four weeks)

  • memory objective

    baseline to last visit (treatment session 20, an average of four weeks)

  • memory subjective

    last visit (treatment session 20, an average of four weeks)

  • +1 more secondary outcomes

Study Arms (3)

A

ACTIVE COMPARATOR

dTMS standard protocol 10 min session

Device: dTMS

B

ACTIVE COMPARATOR

dTMS standard protocol 20 min session

Device: dTMS

C

ACTIVE COMPARATOR

dTMS standard protocol 40 min session

Device: dTMS

Interventions

dTMSDEVICE
ABC

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • see above

You may not qualify if:

  • see above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norra Stockholms Psykiatri

Stockholm, 11251, Sweden

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • johan lundberg, MD PhD

    Norra Stockholms Psykiatri and Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Section head, associate professor, MD PhD

Study Record Dates

First Submitted

October 28, 2016

First Posted

August 29, 2017

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)