Clinical Effect of dTMS in Major Depressive Disorder

NCT ID: NCT03265340

Last Updated: 2019-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

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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

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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))

Conditions

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MAjor Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

dTMS standard protocol 10 min session

Group Type ACTIVE_COMPARATOR

dTMS

Intervention Type DEVICE

B

dTMS standard protocol 20 min session

Group Type ACTIVE_COMPARATOR

dTMS

Intervention Type DEVICE

C

dTMS standard protocol 40 min session

Group Type ACTIVE_COMPARATOR

dTMS

Intervention Type DEVICE

Interventions

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dTMS

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* see above

Exclusion Criteria

* see above
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Section for Affective Disorders; Northern Stockholm Psychiatry

OTHER

Sponsor Role lead

Responsible Party

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Johan Lundberg

Section head, associate professor, MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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johan lundberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Norra Stockholms Psykiatri and Karolinska Institutet

Locations

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Norra Stockholms Psykiatri

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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dTMS dos-respons studie

Identifier Type: -

Identifier Source: org_study_id

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