Clinical Effect of dTMS in Major Depressive Disorder

MAjor Depressive Disorder Clinical Trial

Official title:

Clinical Effect of Deep Transcranial Magnetic Stimulation (dTMS) in Three Different Doses for the Treatment of Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265340
• Other study ID #: dTMS dos-respons studie
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• MAjor Depressive Disorder

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)