Clinical Effect of dTMS in Major Depressive Disorder

March 11, 2019 updated by: Johan Lundberg, Section for Affective Disorders; Northern Stockholm Psychiatry

Clinical Effect of Deep Transcranial Magnetic Stimulation (dTMS) in Three Different Doses for the Treatment of Major Depressive Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

population: inclusion criteria:

  1. Ongoing episode of MDD (ICD10 F32.x) according to MINI/SCID1.
  2. Montgomery Asberg Depression Rating Scale (MADRS) score 20-60
  3. TMS safe exclusion criteria:

1. Bipolar disorder 2. Substance abuse 3. fluoxetine treatment last three weeks 4. Other major Central Nervous System (CNS) disorder 5. Acute medical disorders 6. previous TMS or Electro Convulsive Treatment (ECT) <2 months before inclusion

ratings: MADRS at inclusion, baseline, weekly, at last visit Clinical Global Impression Severity (CGI-S) score at baseline, at last visit Global Self-Evaluation-Memory (GSE-My) at last visit Alcohol Use Disorder Identification Test (AUDIT-C) at inclusion EuroQual 5 Dimension (EQ5D) at baseline, at last visit Quick Inventory of Depressive Symptomatology Self Rating (QIDS-SR) baseline, weekly, last visit

condition: Each subject is randomised to condition A, B or C of dTMS (Brainsway): half the standard protocol (10 min; A), standard protocol (20 min; B) or double standard protocol (40 min, C). 20 treatment sessions/subject. 10 subjects in each group.

Primary endpoint: MADRS at baseline - MADRS at last visit (Intention TO Treat (ITT), Last Observation Carried Forward (LOCF))

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11251
        • Norra Stockholms Psykiatri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • see above

Exclusion Criteria:

  • see above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
dTMS standard protocol 10 min session
Device: dTMS
ACTIVE_COMPARATOR: B
dTMS standard protocol 20 min session
Device: dTMS
ACTIVE_COMPARATOR: C
dTMS standard protocol 40 min session
Device: dTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery Asberg Depression Rating Scale (MADRS) score
Time Frame: baseline to last visit (treatment session 20, an average of four weeks)
MADRS baseline - MADRS last visit (treatment session 20)
baseline to last visit (treatment session 20, an average of four weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression Severity (CGI-S)
Time Frame: baseline to last visit (treatment session 20, an average of four weeks)
CGI-Sbaseline - CGI-S last visit (treatment session 20)
baseline to last visit (treatment session 20, an average of four weeks)
Montgomery Asberg Depression Rating Scale (MADRS) response
Time Frame: last visit (treatment session 20, an average of four weeks)
fraction of subjects with >50% decrease in MADRS
last visit (treatment session 20, an average of four weeks)
Montgomery Asberg Depression Rating Scale (MADRS) remission
Time Frame: last visit (treatment session 20, an average of four weeks)
fraction of subjects with MADRS <10 points
last visit (treatment session 20, an average of four weeks)
memory objective
Time Frame: baseline to last visit (treatment session 20, an average of four weeks)
CPRS memory item at baseline - CPRS memory item at last visit
baseline to last visit (treatment session 20, an average of four weeks)
memory subjective
Time Frame: last visit (treatment session 20, an average of four weeks)
GSE-my at last visit
last visit (treatment session 20, an average of four weeks)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: baseline to last visit (treatment session 20, an average of four weeks)
systematic safety evaluation and registration of side effects
baseline to last visit (treatment session 20, an average of four weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Section for Affective Disorders; Northern Stockholm Psychiatry

Investigators

  • Principal Investigator: johan lundberg, MD PhD, Norra Stockholms Psykiatri and Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2014

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

August 25, 2017

First Posted (ACTUAL)

August 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dTMS dos-respons studie

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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