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Clinical Effect of dTMS in Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03265340
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Johan Lundberg, Section for Affective Disorders; Northern Stockholm Psychiatry

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.

Condition or disease Intervention/treatment Phase
MAjor Depressive Disorder Device: dTMS Not Applicable

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))


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Effect of Deep Transcranial Magnetic Stimulation (dTMS) in Three Different Doses for the Treatment of Major Depressive Disorder
Actual Study Start Date : September 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • see above

Exclusion Criteria:

  • see above

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265340


Locations
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Sweden
Norra Stockholms Psykiatri
Stockholm, Sweden, 11251
Sponsors and Collaborators
Section for Affective Disorders; Northern Stockholm Psychiatry
Investigators
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Principal Investigator: johan lundberg, MD PhD Norra Stockholms Psykiatri and Karolinska Institutet

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Responsible Party: Johan Lundberg, Section head, associate professor, MD PhD, Section for Affective Disorders; Northern Stockholm Psychiatry
ClinicalTrials.gov Identifier: NCT03265340     History of Changes
Other Study ID Numbers: dTMS dos-respons studie
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Johan Lundberg, Section for Affective Disorders; Northern Stockholm Psychiatry:
Transcranial Magnetic Stimulation
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms