Status:
UNKNOWN
Virtual Reality Reward Training and Transcranial Magnetic Stimulation for Depression
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Anhedonia is a core feature of major depressive disorder (MDD) (DSM-5). Functional magnetic resonance imaging (fMRI) studies have associated anhedonia in MDD with altered frontostriatal activity and f...
Detailed Description
This is a non-blinded, randomized sham-controlled trial for effectiveness and feasibility of virtual reward reality training and rTMS for MDD with two arms. Patients with MDD who meet inclusion and ex...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 1\. Female or male patients between ages 18-65 2. Diagnosis of major depressive disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM-5) 3. Hamilton Rating Scale for Depression (17-item) score of at least 16 4. Clinically significant anhedonia as defined by a Smith-Hamilton Pleasure Scale (SHAPS) score of at least 20 (Krystal et al., 2020) 5. On a stable antidepressant regimen for at least 4 weeks before treatment which can continue during treatment and agreement to not make changes or additions to psychotropic medications during the course of their participation in the study 6. Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols
- Exclusion criteria:
- Any past or current evidence of psychosis or mania
- Active neurologic disease
- Any lifetime history of seizures
- Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
- Current active suicidal ideation
- Personality disorder deemed to be the primary pathology
- Taking more than 2 mg lorazepam (or an equivalent) or any anticonvulsant
- Previous rTMS treatment
- Lifetime history of non-response to an adequate course (minimum 8 treatments) of electroconvulsive therapy
- Previous or current engagement in ketamine treatment for major depressive disorder
- Any contraindication to MRI scanning
- Likely to relocate or move out of the country during the study's duration (3-4 months from baseline visit)
- Frequent motion sickness
Exclusion
Key Trial Info
Start Date :
October 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 29 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06178731
Start Date
October 29 2021
End Date
October 29 2024
Last Update
December 21 2023
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5