DepressionNCT05869708
PRISM Neurofeedback Training for MDD Anhedonic Patients
A study testing Active RS-EFP in people with Depression and Anhedonia, run by GrayMatters Health Ltd. at 1 site in United States.
Trial summary
The goal of this interventional double-blind study is to demonstrate the safety and efficacy of PRISM neurofeedback training within an MDD Anhedonia sample. The goals of this study include: 1. Demonstrating the safety and efficacy of Prism Neurofeedback training within an MDD Anhedonia sample; 2. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Depression, Anhedonia
- What is being tested?
- Active RS-EFP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 3 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 22 to 65
- Any gender and all ethnic/racial origins
- Diagnosis of MDD with Anhedonia, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5). MDD diagnosis will be determined via the Structured Clinical Interview for DSM-5 (SCID-V) with ≥17 on the Hamilton Depression Rating Scale (HDRS)-211 and ≥25 on the Snaith-Hamilton Pleasure Scale (SHAPS-C)
- Fluency in written and spoken English
- 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
Who cannot join
- Imaging Exclusions 1. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- 2. Contraindications to MRI (e.g., metal in the body, claustrophobia). 3. Hairstyles that prevent application of the EEG net (e.g., braids, dreadlocks, cornrows, recently dyed hair) Comorbidity Exclusions
- A history of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder, organic mental disorder, severe borderline or antisocial personality disorder, current bulimia nervosa2, current binge eating disorder2, or current anorexia nervosa3.
- Lifetime Diagnosis of autism or intellectual disability at the discretion of the investigator.
- Current primary diagnosis of posttraumatic stress disorder (PTSD), specific phobia, panic disorder, social anxiety disorder, obsessive compulsive disorder, or generalized anxiety disorder; subjects with MDD as a primary diagnosis may be included.
- First-degree relatives with a history of psychotic disorder or psychotic symptoms outside of the context of a mood disorder (i.e., MDD or bipolar disorder)
Show all 23Show fewer
- 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) with the exception of cocaine or stimulant abuse which will lead to an automatic exclusion.
- Additional Substance and Drug Use Exclusions
- Any current drug use as assessed by a positive result on urine drug test (covering cocaine, opiates, amphetamines, methamphetamines, phencyclidine, MDMA, benzodiazepines, methadone, oxycodone, tricyclic antidepressants, and barbiturates)
- Allow positive result for cannabinoids if participant verbally confirms they have not used MJ in past 12 hours prior to study visit
- Use of any antibiotics in the 24 hours prior to an MRI scan procedure
- Recent use (within 4 weeks) or any current medication that affects blood flow or blood pressure, or which is vasodilating/vasoconstricting (for participants undergoing neuroimaging) Medical Exclusions
- 1. Any unstable medical condition, as per the clinical judgement of the investigator.
- 2. A history of seizures, at risk for seizure (e.g., history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes or familial or personal history of epilepsy) or have been diagnosed with a seizure disorder.
- Treatment Exclusions
- Any prescribed Benzodiazepine which cannot be ceased for the duration of the study (with a washout period of at least 2 weeks prior to the first Prism training session) or which cannot be replaced with short-acting benzodiazepines that are taken only for sleeping during the night at equivalent daily dose of up to 3 mg.
- History of ECT, TMS, or Ketamine in the current Major Depressive Episode (allowable in previous MDEs)
- Completion of two full courses of other therapies within the current episode
- Any psychotropic medication other than a stable dose of antidepressants, e.g., bupropion, selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitor (SNRIs), St. John's Wort, or SAMe.
- Any change in - or initiation of - fluoxetine within the past 8 weeks or other SSRIs or SNRIs antidepressants, bupropion, simulants, or other psychiatric medications within the past 4 weeks. At the time of recruitment, patients must have no intention of changing their medication or psychotherapy during the study duration.
- 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
1 site in 1 country.
About this study
Official title: Personalizing Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia Using Clinical Biomarkers for MDD Subtypes
The goal of this interventional double-blind study is to demonstrate the safety and efficacy of PRISM neurofeedback training within an MDD Anhedonia sample.
The goals of this study include:
Read more
- Demonstrating the safety and efficacy of Prism Neurofeedback training within an MDD Anhedonia sample;
- Identifying clinical profile/symptoms-based biomarkers (e.g., Hamilton Depression Rating Scale - HDRS-21, Dimensional Anhedonia Rating Scale - DARS, Snaith-Hamilton Pleasure Scale for Clinicians SHAPS) scores that can be used by clinics to administer Prism therapy in conjunction with standard of care (SOC) therapy;
- Producing initial guidelines for integrating Prism neurofeedback training for MDD therapy with MDD Anhedonia (SOC).
Participants will be randomly assigned to one of two arms, Active, or Sham.
Read the detailed description
During the study, participants will perform the following:
- Complete clinical assessments using questionnaires, an MRI scan, and tasks that probe reward responsivity, learning, and motivation.
- Perform at least 10 sessions but optimally 15 (+/-3) neurofeedback training sessions (performed twice a week on nonconsecutive days for 5-8 weeks).
- Complete the same clinical assessments, post-NF training MRI scan, and tasks same as in the screening/baseline stage.
Researchers will compare the sham and treatment arm to evaluate if the neurofeedback effect reduced MDD symptoms in MDD patients with Anhedonia.
- Conditions
- Depression, Anhedonia
- Being tested
- Active RS-EFP, Sham RS-EFP
- Medical subject headings
- Depression, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active RS-EFPDevice
A minimum of 10 and up to 15 active NF Prism training sessions, aimed to train for upregulating the RS activity. Sessions will occur twice a week, on nonconsecutive days, over 5-8 consecutive weeks. Subjects will also receive two single booster sessions, one month and two months after their last training session.
Sham RS-EFPDevice
a minimum of 10 and up to 15 sham NF Prism training sessions, aimed to train for upregulating the RS activity. Sessions will occur twice a week, on nonconsecutive days, over 5-8 consecutive weeks. Subjects will also receive two single sham booster sessions, one month and two months after their last training session.
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Experimental | Subjects randomized into the Active arm will receive RS-EFP-NF Prism training as an adjunct to standard of care. Receives: Device: Active RS-EFP |
| Control Arm | Sham comparator | Subjects randomized into the Control arm will receive a Sham-EFP-NF training with the same schedule as the active arm, adjunct to standard of care. Receives: Device: Sham RS-EFP |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDRS-21
The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. It is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3- or 5-point scale, depending on the item, and the total score is compared to the corresponding descriptor. Assessment time is about 20 minutes.
Measured: 9 weeks
Secondary outcomes (4)
Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR)
The Snaith Hamilton Pleasure Scale (Snaith et al., 1995) is a 14- item self-administered measure of anhedonic symptoms. The purpose of this assessment is to evaluate the ability to enjoy/experience pleasure in activities in the past week. Each item is rated on a 4-point Likert scale, where the total score ranges between 0 to 42 and a higher total score means a worse outcome.
Measured: 9 weeks
HDRS-21
The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. It is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3- or 5-point scale, depending on the item, and the total score is compared to the corresponding descriptor. Assessment time is about 20 minutes.
Measured: 3 months
Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR)
The Snaith Hamilton Pleasure Scale (Snaith et al., 1995) is a 14- item self-administered measure of anhedonic symptoms. The purpose of this assessment is to evaluate the ability to enjoy/experience pleasure in activities in the past week. Each item is rated on a 4-point Likert scale, where the total score ranges between 0 to 42 and a higher total score means a worse outcome.
Measured: 3 months
The clinical global impression (CGI-I)
The CGI-I Scale - of Clinical Global Impression (Guy et.al, 1976) - is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Rated within the range of 0 to 7, lower scores indicate improved outcomes while higher scores indicate worsen outcomes.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Jul 2023
- Primary completion3 Sep 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- GrayMatters Health Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diego Pizzagalli, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869708
- Sponsor's protocol ID
- CLP011
- Status last verified
- May 2025
- First submitted
- 23 Apr 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalizing Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia Using Clinical Biomarkers for MDD Subtypes
- ClinicalTrials.gov ID
- NCT05869708
- Acronym / sponsor ID
- CLP011
- Conditions
- Depression, Anhedonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- GrayMatters Health Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 22 May 2023 (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 goal of this interventional double-blind study is to demonstrate the safety and efficacy of PRISM neurofeedback training within an MDD Anhedonia sample.
The goals of this study include:
- Demonstrating the safety and efficacy of Prism Neurofeedback training within an MDD Anhedonia sample;
- Identifying clinical profile/symptoms-based biomarkers (e.g., Hamilton Depression Rating Scale - HDRS-21, Dimensional Anhedonia Rating Scale - DARS, Snaith-Hamilton Pleasure Scale for Clinicians SHAPS) scores that can be used by clinics to administer Prism therapy in conjunction with standard of care (SOC) therapy;
- Producing initial guidelines for integrating Prism neurofeedback training for MDD therapy with MDD Anhedonia (SOC).
Participants will be randomly assigned to one of two arms, Active, or Sham.
Detailed description
During the study, participants will perform the following:
- Complete clinical assessments using questionnaires, an MRI scan, and tasks that probe reward responsivity, learning, and motivation.
- Perform at least 10 sessions but optimally 15 (+/-3) neurofeedback training sessions (performed twice a week on nonconsecutive days for 5-8 weeks).
- Complete the same clinical assessments, post-NF training MRI scan, and tasks same as in the screening/baseline stage.
Researchers will compare the sham and treatment arm to evaluate if the neurofeedback effect reduced MDD symptoms in MDD patients with Anhedonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Experimental | Device: Active RS-EFPSubjects randomized into the Active arm will receive RS-EFP-NF Prism training as an adjunct to standard of care. |
| Control Arm | Sham comparator | Device: Sham RS-EFPSubjects randomized into the Control arm will receive a Sham-EFP-NF training with the same schedule as the active arm, adjunct to standard of care. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ages 22 to 65
- Any gender and all ethnic/racial origins
- Diagnosis of MDD with Anhedonia, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5). MDD diagnosis will be determined via the Structured Clinical Interview for DSM-5 (SCID-V) with ≥17 on the Hamilton Depression Rating Scale (HDRS)-211 and ≥25 on the Snaith-Hamilton Pleasure Scale (SHAPS-C)
- Fluency in written and spoken English
- Ability to give signed, informed consent either written or electronic (via REDCap eConsent)
Key exclusion criteria (23 listed)
- Imaging Exclusions 1. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- 2. Contraindications to MRI (e.g., metal in the body, claustrophobia). 3. Hairstyles that prevent application of the EEG net (e.g., braids, dreadlocks, cornrows, recently dyed hair) Comorbidity Exclusions
- A history of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder, organic mental disorder, severe borderline or antisocial personality disorder, current bulimia nervosa2, current binge eating disorder2, or current anorexia nervosa3.
- Lifetime Diagnosis of autism or intellectual disability at the discretion of the investigator.
- Current primary diagnosis of posttraumatic stress disorder (PTSD), specific phobia, panic disorder, social anxiety disorder, obsessive compulsive disorder, or generalized anxiety disorder; subjects with MDD as a primary diagnosis may be included.
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 |
|---|---|---|
| Active RS-EFPA minimum of 10 and up to 15 active NF Prism training sessions, aimed to train for upregulating the RS activity. Sessions will occur twice a week, on nonconsecutive days, over 5-8 consecutive weeks. Subjects will also receive two single booster sessions, one month and two months after their last training session. | Device | Active Arm |
| Sham RS-EFPa minimum of 10 and up to 15 sham NF Prism training sessions, aimed to train for upregulating the RS activity. Sessions will occur twice a week, on nonconsecutive days, over 5-8 consecutive weeks. Subjects will also receive two single sham booster sessions, one month and two months after their last training session. | Device | Control Arm |
Primary outcome
HDRS-21
Time frame: 9 weeks
The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. It is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3- or 5-point scale, depending on the item, and the total score is compared to the corresponding descriptor. Assessment time is about 20 minutes.
4 secondary outcomes
Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR)
Time frame: 9 weeks
HDRS-21
Time frame: 3 months
Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR)
Time frame: 3 months
The clinical global impression (CGI-I)
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Diego Pizzagalli, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active RS-EFP in people with Depression and Anhedonia, run by GrayMatters Health Ltd. at 1 site in United States.
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 23 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: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDRS-21 (time frame: 9 weeks). 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 5 Sep 2025.