Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia
ConditionDepressive Disorder, Major
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorGrayMatters Health Ltd.
About this trial
The purpose of this research is to learn more about a new treatment for individuals with Major Depressive Disorder (MDD) with heightened symptoms of anhedonia (i.e. loss of pleasure or interest in activities). The treatment is called Prism, and it is a software device intended for a novel form of neurofeedback training to be used in a clinic setting.
During this study, the subject will use different techniques to measure brain activities, including magnetic resonance imaging (MRI) and electroencephalography (EEG).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary Diagnosis of MDD with Anhedonia, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM5TR) - HDRS-17 score of ≥20, SHAPS-C score of ≥25.
Fluency in written and spoken English.
Able intellectually to understand the instructions
Ability to give signed, informed consent either written or electronic (via REDCap eConsent).
Disqualifiers
Contraindications to MRI (e.g., metal in the body, claustrophobia).
Any suicidal behavior in the past 1 year (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) assessed using Columbia -Suicide Severity Rating Scale (C-SSRS) prior to screening and during the screening period.
Diagnosis for current moderate or severe substance or alcohol use disorder (SUD/AUD) within the past month (as defined in DSM-5-substance use disorder).
Any unstable medical condition, as per the clinical judgement of the investigator.
Trial design
Design model
Parallel
Treatments tested in this trial
Prism Training
DeviceParticipants will complete 20 Prism training sessions. The Prism training sessions take place twice a week over a 10-week period, with a minimum of one night of sleep between sessions. Participants will also receive two single booster sessions, 4 weeks and 8 weeks after their last NF session completed.
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Active armActive comparator 1 intervention
Group B: Sham armSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
HDRS-21
Hamilton Rating Scale for Depression - the maximum score is 64. A score above 20 is considered a severe depression.
Time frame
Change from baseline to week 12 (post training visit)Secondary outcomes
1
SHAPS-C
Snaith-Hamilton-Pleasure scale - is a 14- item self-administered measure of anhedonia symptoms.
Time frame
Change from baseline to week 12 (post-training visit)2
HDRS-21
Hamilton Rating Scale for Depression - the maximum score is 64. A score above 20 is considered a severe depression.
Time frame
Change from baseline to 3-month FU visit3
CGI-I
Clinical global impression - The 7-point CGI-I scale rates improve with a (1) representing a very much improved' patient and (7) representing a patient who has become 'very much worse' due to treatment. The rating (4) represents a patient displaying no change from the treatment.
Time frame
Change from baseline to week 12 (post-training visit)4
CGI-I
Clinical global impression - The 7-point CGI-I scale rates improve with a (1) representing a very much improved' patient and (7) representing a patient who has become 'very much worse' due to treatment. The rating (4) represents a patient displaying no change from the treatment.
Time frame
Change from week 12 to 3-Month follow-up AssessmentSponsors and contacts
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Source ClinicalTrials.gov