Clinical trial NCT03265340: Clinical Effect of dTMS in Major Depressive Disorder
Official title: Clinical Effect of Deep Transcranial Magnetic Stimulation (dTMS) in Three Different Doses for the Treatment of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MAjor Depressive Disorder
Keywords: Transcranial Magnetic Stimulation
Lead sponsor: Section for Affective Disorders; Northern Stockholm Psychiatry
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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))

Eligibility criteria: Inclusion Criteria:

* see above

Exclusion Criteria:

* see above

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS) score
timeFrame: baseline to last visit (treatment session 20, an average of four weeks)
Secondary outcomes:
measure: Clinical Global Impression Severity (CGI-S)
timeFrame: baseline to last visit (treatment session 20, an average of four weeks)
measure: Montgomery Asberg Depression Rating Scale (MADRS) response
timeFrame: last visit (treatment session 20, an average of four weeks)
measure: Montgomery Asberg Depression Rating Scale (MADRS) remission
timeFrame: last visit (treatment session 20, an average of four weeks)
measure: memory objective
timeFrame: baseline to last visit (treatment session 20, an average of four weeks)
measure: memory subjective
timeFrame: last visit (treatment session 20, an average of four weeks)
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: baseline to last visit (treatment session 20, an average of four weeks)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Norra Stockholms Psykiatri
Study officials:
affiliation: Norra Stockholms Psykiatri and Karolinska Institutet
name: johan lundberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: