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Not yet recruitingNCT07779226DecNefUpdated Oct 14, 2026

DecNef for Auditory Verbal Hallucinations (AVH) in Schizophrenia

An interventional study of Decoded Neurofeedback in Schizophrenia Disorder and Schizoaffecitve Disorder, sponsored by Columbia University. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Columbia University · Not applicable, Interventional, and Other

Updated Oct 14, 2026Start date movedPrimary outcomes revised+6 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to learn whether a research neurofeedback training approach done during MRI scans may help reduce hallucinations such as the experience of hearing voices persistent despite treatment.

Read the detailed description

The overall objective of the current study is to assess the target engagement and efficacy of active decoded neurofeedback (DecNef) as measured by how closely a participant's brain activity aligns with the desired non-AVH-related activation pattern and improvements in AVH measured via the Auditory Hallucination Rating Scale (AHRS). Dose-response curves of target engagement over sessions will be generated.

02

Conditions studied

  • Schizophrenia Disorder
  • Schizoaffecitve Disorder

Keywords

  • Hallucinations
  • Schizophrenia
  • Auditory Verbal Hallucinations
  • Hearing Voices
  • Schizoaffective
  • MRI
03

In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's planned enrollment of 51 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals aged 18 to 55, inclusive at screen
  • Capable of understanding the study procedures and willing and able to provide
  • Diagnosed with schizophrenia or schizoaffective disorder
  • Taking an antipsychotic medication at a stable dose for at least 4 weeks. All oral and depot antipsychotics are allowable.
  • Mean Auditory Hallucination Rating Scale (AHRS) score >2 (moderate) and AHRS Frequency ≥ 4 (hourly AVH: Frequent at least 3 to 6 per hour).
  • Meeting the decoder performance criterion, operationalized as ≥ 55% decoding accuracy. Baseline MRI may be repeated once for subthreshold decoder-accuracy at the discretion of the PIs.
  • Normal hearing, operationalized as normal conversational hearing.
  • Willing to use qualified methods of (listed in section 5.3) for the study duration (for persons of only, unless or surgically sterile).

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of moderate or severe substance use disorder (excluding nicotine) within the previous 90 days
  • Positive toxicology screen for any substances of abuse
  • Participation in study of medication/device within the past 4 weeks
  • Pregnant persons. Persons of must have a negative urine β-hCG pregnancy test at Visit 1 and Visit 1a (if applicable)
  • Any or unstable medical illness, condition, or disorder that is anticipated to potentially compromise participant safety during study, including history of seizure, epilepsy in self or first degree relatives, stroke, brain surgery, head injury with loss of consciousness > 1 hour or clear cognitive sequelae, intracranial metal implants, known structural brain lesions.
  • to MRI scanning, including metal implants or clinically meaningful claustrophobia
  • Participants with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 3 months prior to screening or participants who represent a significant risk of suicide or violence in the opinion of the investigator.
  • History of significant violent behavior in the past 3 months, posing a risk of homicide or having symptoms that would be exacerbated by study participation or travel to the site in the opinion of the investigator.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
51 participants (estimated)

Study arms

  • Experimental
    Active Decoded Neurofeedback

    Decoded Neurofeedback is a real-time fMRI technique designed to modulate within-region activation patterns via pattern-based neurofeedback, which is thought to induce selective plasticity. In this study, we are targeting schizophrenia symptoms.

    Other: Decoded Neurofeedback

  • Active comparator
    Control

    The active comparator is similar to the experimental condition but does not target schizophrenia symptoms.

    Other: Decoded Neurofeedback

Interventions

  • OtherDecoded Neurofeedback

    In this study participants will be randomly assigned to either active or control decoded neurofeedback.

06

What researchers measure

Primary outcomes

  1. Target Engagement

    Target engagement will be evaluated by assessing how closely a participant's brain activity aligns with the desired activation pattern as determined by the fMRI decoder.

    Time frame: During MRI sessions (from randomization through final MRI scan).

  2. Auditory Hallucination Rating Scale

    The Auditory Hallucination Rating Scale (AHRS) will be the primary tool to evaluate auditory verbal hallucinations. The full scale ranges from 0 to 41, where a higher score indicates more severe hallucinations.

    Time frame: During assessment administration (from randomization through final MRI scan)

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: Yes — Data will be shared via the NIMH data sharing archive.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Jan 2028, 13 months later.

Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 13 months is below that.

Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Oct 14, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2026
First posted
Aug 21, 2026
StartEst.
Dec 2026was Sep 2026
Primary completionEst.
Jan 1, 2028
CompletionEst.
Mar 31, 2028
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed
Show site
  • Columbia University Irving Medical Center · New York, United States
Show 1 removed
  • Columbia University · New York, United States
Oct 14, 2026
Start date
Sep 1, 2026→Dec 2026
Oct 14, 2026
Interventions
Added Decoded Neurofeedback; removed Device: Decoded Neurofeedback
Oct 14, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionAuditory Hallucination Rating Scale: how it is measured was reworded
Oct 14, 2026
Title
DecNef for Auditory Verbal Hallucinations (AVH) in Schizophrenia
Oct 14, 2026
Sponsor
New York State Psychiatric Institute→Columbia University; Collaborators added: New York State Psychiatric Institute·National Institute of Mental Health (NIMH); collaborators removed: Columbia University
Oct 14, 2026
Design
Added Not applicable; removed Phase 1·Phase 2
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    1 site added, 1 site removed
    Show site
    • Columbia University Irving Medical Center · New York, United States
    Show 1 removed
    • Columbia University · New York, United States
    Start date Sep 1, 2026→Dec 2026
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionAuditory Hallucination Rating Scale: how it is measured was reworded
    Interventions Added Decoded Neurofeedback; removed Device: Decoded Neurofeedback
    Sponsor New York State Psychiatric Institute→Columbia University; Collaborators added: New York State Psychiatric Institute·National Institute of Mental Health (NIMH); collaborators removed: Columbia University
    Design Added Not applicable; removed Phase 1·Phase 2
    Title DecNef for Auditory Verbal Hallucinations (AVH) in Schizophrenia
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07779226
Responsible party
Guillermo Horga (Associate Professor of Psychiatry, Columbia University) — Principal investigator
First posted
Aug 21, 2026
Start date
Dec 2026 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Oct 14, 2026

Study contacts

Katelyn Mills
Contact
katelyn.mills@nyspi.columbia.edu
646-774-8496
Guillermo Horga, MD, PhD
principal investigator · Columbia University
Joshua Kantrowitz, MD
study chair · Columbia University / New York State Psychiatric Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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