Skip to main content
OpenTrials
Completed

NCT Number: NCT03265340

Clinical Effect of dTMS in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norra Stockholms Psykiatri

Stockholm, 11251, Sweden

About this study

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:
  • 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))

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • see above

Exclusion criteria

  • see above

Treatment and study plan

dTMS

Device

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. memory subjective

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

    GSE-my at last visit

  6. 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

Sponsors and collaborators

Lead sponsor

Section for Affective Disorders; Northern Stockholm Psychiatry

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 29, 2017
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.