NCT07364981

Brief Summary

The main objective of this randomized controlled trial is to evaluate whether a gaze-contingent feedback task using negative reinforcement can serve as an effective attention-modification procedure and contribute to the treatment of Major Depressive Disorder (MDD).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
45mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jan 2026Jan 2030

First Submitted

Initial submission to the registry

December 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

December 29, 2025

Last Update Submit

January 18, 2026

Conditions

Major Depressive Disorder (MDD)

Keywords

MDDattention allocationpositive reinforcementnegative reinforcement

Outcome Measures

Primary Outcomes (1)

  • MADRS- diagnostic interview scores

    Change from baseline- the Montgomery Asberg Depression Rating scale is a clinician-administered scale that includes 10 items that measure the severity of depressive symptoms. Each of the 10 items is scored on a 7-point scale (0-6). The total score, ranging from 0 to 60 is used to assess severity.

    Post-treatment (1 week after treatment completion) and 3-month follow up

Secondary Outcomes (1)

  • PHQ-9 - self report measure

    Post-treatment (1 week after treatment completion) and 3-month follow up

Other Outcomes (2)

  • Attention Allocation

    Post-treatment (1 week after treatment completion) and 3-month follow up

  • M.I.N.I diagnosis- diagnostic interview

    Post-treatment (1 week after treatment completion) and 3-month follow up

Study Arms (2)

Gaze contingent negative reinforcement

ACTIVE COMPARATOR

participants will receive gaze-contingent negative reinforcement according to their viewing patterns

Behavioral: Aversive white noise

Gaze contingent positive reinforcement

PLACEBO COMPARATOR

participants will receive gaze-contingent positive reinforcement according to their viewing patterns

Behavioral: Music reward

Interventions

Aversive white noiseBEHAVIORAL

Participants will receveve gaze-contingent negative-reinforcement feedback according to their viewing patterns, such that when gazing at the target stimuli (i.e., happy faces) the noise will stop.

Gaze contingent negative reinforcement
Music rewardBEHAVIORAL

Participants will receive gaze-contingent music-reward according to their viewing patterns, such that when gazing at the target stimuli (i.e., happy faces) the music will play.

Gaze contingent positive reinforcement

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary diagnosis of MDD
  • MADRS\>=7
  • Normal or corrected-t-normal vision

You may not qualify if:

  • Present or past psychosis, manic or hypomanic episode, PTSD
  • High suicidal ideation or behavior
  • Severe alcohol or cannabis use disorder, and/or any severity of other substance use disorder (exepct nicotine use)
  • Pharmacological treatment if not stabilized for at least three months or concurrent psychotherapy
  • Current unstable or untreated medical illness
  • Current or past organic mental disorder, seizure or brain injury
  • Eye-tracking calibration difficulties
  • Post-ECT treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv University

Tel Aviv, 6997801, Israel

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Amit Lazarov, PhD

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shani Lavi, M.A.

CONTACT

+972 50 2656664shanilavi@mail.tau.ac.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology, School of Psychological Sciences

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 23, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)