Schizophrenia DisorderDecNefNCT07779226
DecNef for Auditory Verbal Hallucinations (AVH) in Schizophrenia
A study testing Decoded Neurofeedback in people with Schizophrenia Disorder and Schizoaffecitve Disorder, run by Columbia University at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia Disorder, Schizoaffecitve Disorder
- What is being tested?
- Decoded Neurofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2026to 31 Mar 2028
- Phase
- Interventional
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals aged 18 to 55, inclusive at screen
- Capable of understanding the study procedures and willing and able to provide informed consent
- 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 contraception (listed in section 5.3) for the study duration (for persons of childbearing potential only, unless post-menopausal or surgically sterile).
Who cannot join
- 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 investigational medication/device within the past 4 weeks
- Pregnant persons. Persons of child-bearing potential must have a negative urine β-hCG pregnancy test at Visit 1 and Visit 1a (if applicable)
- Any clinically significant 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.
- Contraindication 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Columbia University Irving Medical Center
New York, New York, 10027
Tessel Veldhoen
New York State Psychiatric Institute
New York, New York, 10032
Katelyn Mills, 646-774-8496, katelyn.mills@nyspi.columbia.edu
About this study
Official title: Decoded fMRI Neurofeedback for Auditory Verbal Hallucinations in Schizophrenia
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.
- Conditions
- Schizophrenia Disorder, Schizoaffecitve Disorder
- Being tested
- Decoded Neurofeedback
- Keywords
- Hallucinations, Schizophrenia, Auditory Verbal Hallucinations, Hearing Voices, Schizoaffective, MRI
- Medical subject headings
- Schizophrenia, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decoded NeurofeedbackOther
In this study participants will be randomly assigned to either active or control decoded neurofeedback.
| Study group | Role | What they receive |
|---|---|---|
| Active Decoded Neurofeedback | Experimental | 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. Receives: Other: Decoded Neurofeedback |
| Control | Active comparator | The active comparator is similar to the experimental condition but does not target schizophrenia symptoms. Receives: Other: Decoded Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During MRI sessions (from randomization through final MRI scan).
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.
Measured: During assessment administration (from randomization through final MRI scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study startDec 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisorderStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Psychiatric Institute, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Guillermo Horga, Columbia University
- Investigators
- Guillermo Horga, MD, PhD, Principal investigator, Columbia UniversityJoshua Kantrowitz, MD, Study chair, Columbia University / New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779226
- Sponsor's protocol ID
- ACYY1078
- Other IDs
- R61MH143195
- Acronym
- DecNef
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared via the NIMH data sharing archive.