Major Depressive Disorder Clinical Trial
Official title:
A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
The study will involve a 3-week (15 session) randomized double-blind clinical trial of two
repetitive transcranial magnetic stimulation (rTMS) conditions in patients with treatment
resistant depression. rTMS site selection will be localized from structural MRI scans.
The patients will be randomized to one of two conditions
1. rTMS targeted to the border of Brodmann area 46 and Brodmann area 9,
2. rTMS targeted to premotor cortex (this condition will act as the non-dorsolateral
prefrontal cortex targeted control).
The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is
administered at baseline and on a fortnightly basis. At study end response criteria is
defined as a 50% reduction in total MADRS score and remission defined as a MADRS score of
less than or equal to 10.
Other outcome measures administered fortnightly are: BPRS (Brief Psychiatric Rating Scale),
CORE (measure of melancholic symptoms), BDI (Beck Depression Inventory), CGI (Clinical
Global Impression Scale), GAF (Global Assessment of Functioning Scale). A cognitive battery
is also administered.
Inclusion Criteria:
- Moderate to severe depressive symptoms as indicated as MADRS >20
- Failure to respond to a minimum of two antidepressant medications
- No increase or initiation of new antidepressant therapy in the four weeks prior to
entering the trial Exclusion Criteria
- Have an unstable medical condition, neurological disorder or any history of seizure
disorder or are currently pregnant or lactating
- Previous brain injury or surgery, any metal clips, plates or other metal items in the
head, cardiac pacemaker
- In the opinion of the investigator, are a sufficient suicide risk to require immediate
electroconvulsive therapy
- Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis
of a personality disorder or another axis 1 disorder
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05537558 -
Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
|
||
Terminated |
NCT02192099 -
Open Label Extension for GLYX13-C-202, NCT01684163
|
Phase 2 | |
Completed |
NCT03142919 -
Lipopolysaccharide (LPS) Challenge in Depression
|
Phase 2 | |
Recruiting |
NCT05547035 -
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
|
N/A | |
Terminated |
NCT02940769 -
Neurobiological Effects of Light on MDD
|
N/A | |
Recruiting |
NCT05892744 -
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
|
Phase 4 | |
Recruiting |
NCT05537584 -
SMART Trial to Predict Anhedonia Response to Antidepressant Treatment
|
Phase 4 | |
Active, not recruiting |
NCT05061706 -
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
|
Phase 3 | |
Completed |
NCT04479852 -
A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
|
Phase 2 | |
Recruiting |
NCT04032301 -
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
|
Phase 1 | |
Recruiting |
NCT05527951 -
Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study
|
N/A | |
Completed |
NCT03511599 -
Cycloserine rTMS Plasticity Augmentation in Depression
|
Phase 1 | |
Recruiting |
NCT04392947 -
Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation
|
N/A | |
Recruiting |
NCT05895747 -
5-HTP and Creatine for Depression R33 Phase
|
Phase 2 | |
Recruiting |
NCT05273996 -
Predictors of Cognitive Outcomes in Geriatric Depression
|
Phase 4 | |
Recruiting |
NCT05813093 -
Interleaved TMS-fMRI in Ultra-treatment Resistant Depression
|
N/A | |
Recruiting |
NCT05135897 -
The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
|
||
Enrolling by invitation |
NCT04509102 -
Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder
|
Early Phase 1 | |
Recruiting |
NCT06145594 -
EMA-Guided Maintenance TMS for Depression
|
N/A | |
Recruiting |
NCT06026917 -
Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
|
Phase 4 |