Depressive Disorder, MajorNCT06982820
Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia
A study testing Prism Training in people with Depressive Disorder, Major, run by GrayMatters Health Ltd. at 3 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Prism Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 25 Jun 2025to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Normal or corrected-to-normal vision and hearing.
- Ability to adhere to the study schedule.
- Completed at least one antidepressant treatment course at an adequate dose and duration in the current episode per the ATRQ.
Who cannot join
- 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.
- Any change in, or initiation of, fluoxetine within the past 8 weeks or of other SSRIs/SNRIs antidepressants, bupropion, stimulants, or other psychiatric medications within the past 4 weeks.
- Recent initiation (within the past 2 months) of psychotherapy; continuation of established maintenance supportive therapy will be permitted.
- Enrollment in another therapeutic clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Houston Center For Advanced Psychiatric Treatment
Houston, Texas, 77401
Sarah Hartigan, 832-730-5196, sarah@sprashadmd.com
Crystal Islas, (832) 436-4055 x110, crystal@sprashadmd.com
- Recruiting
Butler Hospital
Providence, Rhode Island, 02906
Eric Tirrell, 401-455-6633, ETirrell@Butler.org
Linda Carpenter, MD
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Sharon Baltansky, B.A., 052-6668419, Innomind.research@sheba.health.gov.il
Maayan Nur, M. S C, 052-6668419, Maayan.Nur@sheba.health.gov.il
About this study
Official title: A Prospective, Randomized, Double-blind, Controlled Study to Produce Guidelines for Integrating Prism for MDD Therapy (Reward System [RS] Upregulation) and to Demonstrate Its Superiority Over Sham Therapy
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).
Read the detailed description
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:
- H0: M(Anhedonic)RS-EFP = M(Anhedonic)Sham-EFP
- H1: M(Anhedonic)RS-EFP ≠ M(Anhedonic)Sham-EFP
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
- Conditions
- Depressive Disorder, Major
- Being tested
- Prism Training
- Keywords
- Major Depressive Disorder (MDD), Anhedonia, Depression
- Medical subject headings
- Depressive Disorder, Major, Anhedonia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prism TrainingDevice
Also called Sham Training
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Prism Training |
| 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. Receives: Device: Prism Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDRS-21
Hamilton Rating Scale for Depression - the maximum score is 64. A score above 20 is considered a severe depression.
Measured: Change from baseline to week 12 (post training visit)
Secondary outcomes (5)
SHAPS-C
Snaith-Hamilton-Pleasure scale - is a 14- item self-administered measure of anhedonia symptoms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to week 12 (post-Training visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start25 Jun 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, double-blind, controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GrayMatters Health Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aron Tendler, MD, Study director, GrayMatters Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982820
- Sponsor's protocol ID
- CLP015
- Status last verified
- Mar 2026
- First submitted
- 29 Apr 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Controlled Study to Produce Guidelines for Integrating Prism for MDD Therapy (Reward System [RS] Upregulation) and to Demonstrate Its Superiority Over Sham Therapy
- ClinicalTrials.gov ID
- NCT06982820
- Acronym / sponsor ID
- CLP015
- Conditions
- Depressive Disorder, Major
- Keywords
- Major Depressive Disorder (MDD), Anhedonia, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- GrayMatters Health Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- H0: M(Anhedonic)RS-EFP = M(Anhedonic)Sham-EFP
- H1: M(Anhedonic)RS-EFP ≠ M(Anhedonic)Sham-EFP
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, randomized, double-blind, controlled study
| Arm | Type | Receives |
|---|---|---|
| Active arm | Active comparator | Device: Prism TrainingParticipants randomized into the Active arm will receive reward system EEG-fMRI pattern (RS-EFP) Neuro Feedback (NF) Prism training as an adjunct to SOC. |
| Sham arm | Sham comparator | Device: Prism TrainingParticipants randomized into the Sham arm will receive a Sham EFP-NF training with the same schedule as the active arm, adjunct to SOC. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
- Normal or corrected-to-normal vision and hearing.
Key exclusion criteria (7 listed)
- 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.
- Any change in, or initiation of, fluoxetine within the past 8 weeks or of other SSRIs/SNRIs antidepressants, bupropion, stimulants, or other psychiatric medications within the past 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prism TrainingAlso: Sham TrainingParticipants 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. | Device | Active arm, Sham arm |
Primary outcome
HDRS-21
Time frame: Change from baseline to week 12 (post training visit)
Hamilton Rating Scale for Depression - the maximum score is 64. A score above 20 is considered a severe depression.
5 secondary outcomes
SHAPS-C
Time frame: Change from baseline to week 12 (post-training visit)
HDRS-21
Time frame: Change from baseline to 3-month FU visit
CGI-I
Time frame: Change from baseline to week 12 (post-training visit)
CGI-I
Time frame: Change from week 12 to 3-Month follow-up Assessment
PHQ-9
Time frame: Change from baseline to week 12 (post-Training visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
Related trials for Depressive Disorder, Major
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Major Depressive Episode (MDE), Major Depressive Disorder (MDD)
RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
Not yet recruiting
Acceptance and Committment Therapy Combined With Ketamine in Difficult-to-Treat Depression.
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aron Tendler, MD study director
GrayMatters Health
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prism Training in people with Depressive Disorder, Major, run by GrayMatters Health Ltd. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adar Shani, MSc (+972-54-2347770, adar@graymatters-health.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDRS-21 (time frame: Change from baseline to week 12 (post training visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.