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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).
The study is comprised of the Screening Visit, Baseline Assessment, Pre-training Visit, 20 NF Training Visits (two training visits per week over 10 weeks), two Booster NF Training Visits (Week 16, and Week 20, and the 3-Month Follow-up Assessment Visit (Week 24).
Participants will receive 20 NF sessions.
The study will test the following hypothesis:
Where:
M(Anhedonic)RS-EFP and M(Anhedonic)Sham-EFP are the mean changes from baseline HDRS-17 score in the Active and Sham arms of the Anhedonic MDD participants.
*HDRS-21 is administered for cluster analysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active arm | Active Comparator | Participants randomized into the Active arm will receive reward system EEG-fMRI pattern (RS-EFP) Neuro Feedback (NF) Prism training as an adjunct to SOC. |
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| Sham arm | Sham Comparator | Participants randomized into the Sham arm will receive a Sham EFP-NF training with the same schedule as the active arm, adjunct to SOC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prism Training | Device | Participants 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HDRS-21 | Hamilton Rating Scale for Depression - the maximum score is 64. A score above 20 is considered a severe depression. | Change from baseline to week 12 (post training visit) |
| Measure | Description | Time Frame |
|---|---|---|
| SHAPS-C | Snaith-Hamilton-Pleasure scale - is a 14- item self-administered measure of anhedonia symptoms. | Change from baseline to week 12 (post-training visit) |
| HDRS-21 | Hamilton Rating Scale for Depression - the maximum score is 64. A score above 20 is considered a severe depression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adar Shani, MSc | Contact | +972-54-2347770 | adar@graymatters-health.com | |
| Jennifer Yarden, PhD | Contact | +972-52-4897823 | jennifer@graymatters-health.com |
| Name | Affiliation | Role |
|---|---|---|
| Aron Tendler, MD | GrayMatters Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Recruiting | Providence | Rhode Island | 02906 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D059445 | Anhedonia |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
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A prospective, randomized, double-blind, controlled study
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Double-blind: neither participants nor clinicians assessing them will have information regarding the treatment arm.
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| Change from baseline to 3-month FU visit |
| 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. | Change from baseline to week 12 (post-training visit) |
| 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. | Change from week 12 to 3-Month follow-up Assessment |
| PHQ-9 | Patient Health Questionnaire-9 - The PHQ-9 is a nine-item depressive symptom diagnostic tool. | Change from baseline to week 12 (post-Training visit) |
| Houston Center For Advanced Psychiatric Treatment | Recruiting | Houston | Texas | 77401 | United States |
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| Sheba Medical Center | Recruiting | Ramat Gan | Israel |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |