Clinical Effect of dTMS in Major Depressive Disorder

Not Applicable

Completed

• Conditions: MAjor Depressive Disorder

• Registration Number: NCT03265340
• Lead Sponsor: 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.

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))

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-29
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• see above

Exclusion Criteria

• see above

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale (MADRS) score	baseline to last visit (treatment session 20, an average of four weeks)	MADRS baseline - MADRS last visit (treatment session 20)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Norra Stockholms Psykiatri; 🇸🇪 Stockholm, Sweden