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Clinical Effect of dTMS in Major Depressive Disorder

Primary Purpose

MAjor Depressive Disorder

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

dTMS

About this trial

This is an interventional treatment trial for MAjor Depressive Disorder focused on measuring Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

see above

Exclusion Criteria:

see above

Sites / Locations

Norra Stockholms Psykiatri

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm Description

dTMS standard protocol 10 min session

dTMS standard protocol 20 min session

dTMS standard protocol 40 min session

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale (MADRS) score

MADRS baseline - MADRS last visit (treatment session 20)

Secondary Outcome Measures

Clinical Global Impression Severity (CGI-S)

CGI-Sbaseline - CGI-S last visit (treatment session 20)

Montgomery Asberg Depression Rating Scale (MADRS) response

fraction of subjects with >50% decrease in MADRS

Montgomery Asberg Depression Rating Scale (MADRS) remission

fraction of subjects with MADRS <10 points

memory objective

CPRS memory item at baseline - CPRS memory item at last visit

memory subjective

GSE-my at last visit

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

systematic safety evaluation and registration of side effects

Full Information

NCT ID

NCT03265340

First Posted

October 28, 2016

Last Updated

March 11, 2019

Sponsor

Section for Affective Disorders; Northern Stockholm Psychiatry

1. Study Identification

Unique Protocol Identification Number

NCT03265340

Brief Title

Clinical Effect of dTMS in Major Depressive Disorder

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

September 2014 (Actual)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Section for Affective Disorders; Northern Stockholm Psychiatry

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

population: inclusion criteria: Ongoing episode of MDD (ICD10 F32.x) according to MINI/SCID1. Montgomery Asberg Depression Rating Scale (MADRS) score 20-60 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))

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

MAjor Depressive Disorder

Keywords

Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

dTMS standard protocol 10 min session

Arm Title

Arm Type

Active Comparator

Arm Description

dTMS standard protocol 20 min session

Arm Title

Arm Type

Active Comparator

Arm Description

dTMS standard protocol 40 min session

Intervention Type

Device

Intervention Name(s)

dTMS

Primary Outcome Measure Information:

Title

Montgomery Asberg Depression Rating Scale (MADRS) score

Description

MADRS baseline - MADRS last visit (treatment session 20)

Time Frame

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

Secondary Outcome Measure Information:

Title

Clinical Global Impression Severity (CGI-S)

Description

CGI-Sbaseline - CGI-S last visit (treatment session 20)

Time Frame

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

Title

Montgomery Asberg Depression Rating Scale (MADRS) response

Description

fraction of subjects with >50% decrease in MADRS

Time Frame

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

Title

Montgomery Asberg Depression Rating Scale (MADRS) remission

Description

fraction of subjects with MADRS <10 points

Time Frame

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

Title

memory objective

Description

CPRS memory item at baseline - CPRS memory item at last visit

Time Frame

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

Title

memory subjective

Description

GSE-my at last visit

Time Frame

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

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Description

systematic safety evaluation and registration of side effects

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: see above Exclusion Criteria: see above

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

johan lundberg, MD PhD

Organizational Affiliation

Norra Stockholms Psykiatri and Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Norra Stockholms Psykiatri

City

Stockholm

ZIP/Postal Code

11251

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Effect of dTMS in Major Depressive Disorder

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