Study Results
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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COMPLETED
NA
29 participants
INTERVENTIONAL
2014-09-30
2016-09-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
dTMS standard protocol 10 min session
dTMS
B
dTMS standard protocol 20 min session
dTMS
C
dTMS standard protocol 40 min session
dTMS
Interventions
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dTMS
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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Section for Affective Disorders; Northern Stockholm Psychiatry
OTHER
Responsible Party
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Johan Lundberg
Section head, associate professor, MD PhD
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
Countries
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Other Identifiers
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dTMS dos-respons studie
Identifier Type: -
Identifier Source: org_study_id
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