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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03265340
Other study ID # dTMS dos-respons studie
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date September 2016

Study information

Verified date March 2019
Source Section for Affective Disorders; Northern Stockholm Psychiatry
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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))


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- see above

Exclusion Criteria:

- see above

Study Design


Intervention

Device:
dTMS


Locations

Country Name City State
Sweden Norra Stockholms Psykiatri Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Section for Affective Disorders; Northern Stockholm Psychiatry

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Montgomery Asberg Depression Rating Scale (MADRS) score MADRS baseline - MADRS last visit (treatment session 20) baseline to last visit (treatment session 20, an average of four weeks)
Secondary Clinical Global Impression Severity (CGI-S) CGI-Sbaseline - CGI-S last visit (treatment session 20) baseline to last visit (treatment session 20, an average of four weeks)
Secondary Montgomery Asberg Depression Rating Scale (MADRS) response fraction of subjects with >50% decrease in MADRS last visit (treatment session 20, an average of four weeks)
Secondary Montgomery Asberg Depression Rating Scale (MADRS) remission fraction of subjects with MADRS <10 points last visit (treatment session 20, an average of four weeks)
Secondary memory objective CPRS memory item at baseline - CPRS memory item at last visit baseline to last visit (treatment session 20, an average of four weeks)
Secondary memory subjective GSE-my at last visit last visit (treatment session 20, an average of four weeks)
Secondary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] systematic safety evaluation and registration of side effects baseline to last visit (treatment session 20, an average of four weeks)
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