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Brain-training device shows promise for depression with anhedonia

NCT ID NCT05869708

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This small study tested a device called Prism that uses neurofeedback to train the brain to regulate its own activity. Nineteen adults with major depressive disorder and anhedonia (loss of pleasure) were randomly assigned to real or sham training sessions over several weeks. The goal was to see if the device is safe and can reduce depression symptoms and improve the ability to feel pleasure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prism neurofeedback device (brain-training using real-time feedback)
What this could lead to
If it works, this could offer a non-drug option to help people with depression who also struggle with anhedonia (loss of pleasure).
What could go wrong
This was a very small, early study (19 people) comparing active to sham training. Results may not apply to everyone, and the device is not yet proven effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

19 people

The number who actually took part.

Started

Jul 2023

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

MDD subjects Inclusion Criteria: 1. Ages 22 to 65 2. Any gender and all ethnic/racial origins 3. 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) 4. Fluency in written and spoken English 5. Ability to give signed, informed consent either written or electronic (via REDCap eConsent) 6. Normal or corrected-to-normal vision and hearing 7. Ability to adhere to the study schedule Exclusion Criteria (All Subjects): 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 1. 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. 2. Lifetime Diagnosis of autism or intellectual disability at the discretion of the investigator. 3. 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. 4. 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) 5. 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. 6. 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 1. 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) 1. Allow positive result for cannabinoids if participant verbally confirms they have not used MJ in past 12 hours prior to study visit 2. Use of any antibiotics in the 24 hours prior to an MRI scan procedure 3. 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 1. 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. 2. History of ECT, TMS, or Ketamine in the current Major Depressive Episode (allowable in previous MDEs) 3. Completion of two full courses of other therapies within the current episode 4. 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. 5. 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. 6. Recent initiation (within the past 2 months) of psychotherapy; continuation of established maintenance supportive therapy will be permitted. 7. Enrollment in another therapeutic clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • McLean Hospital

    Belmont, Massachusetts, 02478, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.