Clinical Effect of dTMS in Major Depressive Disorder

Section for Affective Disorders; Northern Stockholm Psychiatry

Status: Completed

Conditions: MAjor Depressive Disorder

Treatments: Device: dTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03265340

dTMS dos-respons studie

Details and patient eligibility

About

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.

Full 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:

4. 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))

Enrollment: 29 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• see above

Exclusion criteria

• see above

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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29 participants in 3 patient groups

A

Active Comparator group

Description:

dTMS standard protocol 10 min session

Treatment:

Device: dTMS

B

Active Comparator group

Description:

dTMS standard protocol 20 min session

Treatment:

Device: dTMS

C

Active Comparator group

Description:

dTMS standard protocol 40 min session

Treatment:

Device: dTMS