DepressionEarly Phase 1NCT06361095
Confirmatory Efficacy Trial of Attention Bias Modification for Depression
A Early Phase 1 study testing Traditional Attention Bias Modification and Gamified Attention Bias Modification in people with Depression, run by University of Texas at Austin at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare the efficacy of two related, but different ABM (Attention Biased Modification) treatments for depression in adults with elevated symptoms of depression. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- Traditional Attention Bias Modification and Gamified Attention Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 1 May 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provided informed consent
- Fluent in English
- Scored 13 or greater on the QIDS-SR at the baseline assessment
- Between the ages of 18 to 70
- Have had no changes in medication and dosage in the past 12 weeks (if currently on antidepressant medication)
Who cannot join
- Reported suicidal behavior or significant suicidal ideation within the past six months using the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Met criteria for current or past bipolar or psychotic disorders
- Current (i.e., within the past 12 months) substance use disorders of moderate or greater severity on the Mini International Neuropsychiatric Interview (MINI)
- Currently taking opioid analgesics or systemic corticosteroid use as these medications
- Currently receiving psychotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Institute for Mental Health Research
Austin, Texas, 78705
Christopher G Beevers, PhD, beevers@utexas.edu
beevers@utexas.edu
About this study
Official title: Confirmatory Efficacy Trial of a Traditional vs. Gamified Attention Bias Modification for Depression
The goal of this clinical trial is to compare the efficacy of two related, but different ABM (Attention Biased Modification) treatments for depression in adults with elevated symptoms of depression. The main aims are:
- Aim 1:examine whether gamified ABM leads to greater change in the primary and secondary outcomes than sham ABM
- Aim 1: establish that gamified ABM is at least as effective as traditional ABM.
- Aim 2: identify moderators of ABM efficacy and mechanisms responsible for its efficacy.
- Aim 3: Identify the durability of ABM on depression symptoms during short-term follow-up
Read more
Participants will complete self-report questionnaires, complete eye-tracking tasks, and be clinically assessed through interviews by clinician researchers.
If there is a comparison group: Researchers will compare sham, traditional, and gamified treatment groups to see if they moderate symptoms of depression.
Read the detailed description
The overall goal of this project is to conduct a well-powered confirmatory efficacy trial comparing a gamified, attention bias modification (ABM) mobile application and traditional ABM to sham ABM among adults with elevated symptoms of depression. The proposed R01 efficacy trial follows the NIMH intervention development sequence as it builds upon prior NIMH-funded experimental therapeutics work, specifically R21MH092430 "Attention training for Major Depressive Disorder" and R33MH109600 "Development of attention bias modification for depression". This prior work demonstrates that active ABM engages and alters negative attention bias and there is a preliminary efficacy signal that ABM reduces depression. Although traditional ABM is efficacious for the treatment of depression, "gamified" forms of ABM have the potential to be more accessible and engaging than traditional ABM. Pilot work suggests that a gamified ABM can reduce negative affect; however, its effectiveness for depression has not yet been established. Thus, investigators are proposing to conduct a well-powered, confirmatory efficacy trial to determine ABM's potential for the treatment of depression. In Aim 1, the investigators will examine the efficacy of ABM in a large sample of adults (N = 600) with elevated symptoms of depression. The investigators hypothesize that gamified and traditional ABM will lead to significantly greater reductions in self-reported and interviewer-rated depression symptoms than sham ABM. The investigators further hypothesize that traditional ABM will be non-inferior to gamified ABM (treatment superiority between the ABM conditions will also be tested). In Aim 2, the investigators will examine putative moderators and mediators of ABM. Based on ABM research with anxious populations, it is predicted that people with a strong initial attentional bias for sad stimuli will experience greater reductions in depression in response to either gamified or traditional ABM than sham ABM. In terms of mediation, compared to sham ABM, the investigators hypothesize that gamified and traditional ABM will: (1) decrease negative attentional bias measured behaviorally with reliable eye tracking methods; (2) significantly reduce depression; and (3) improve depression symptoms via their influence on negative attentional bias. Selection of the putative mediators is informed by our prior R33 ABM trial, where it was found that gaze bias away from sad stimuli mediated the effect of traditional ABM on depression symptom change. In Aim 3, an exploratory aim, the investigators will estimate the durability of ABM by collecting post-treatment symptom data 1-, 2-, 3-, and 6-months after ABM completion. Symptom change and reliable recovery across a six-month follow-up period will be estimated. Currently, the durability of ABM effects for depression is unknown, as few well-powered ABM studies for depression have obtained follow-up data. This trial would provide the most definitive data to date regarding whether ABM for depression is a promising treatment for depression.
- Conditions
- Depression
- Being tested
- Traditional Attention Bias Modification, Gamified Attention Bias Modification, Sham Attention Bias Modification
- Keywords
- depression treatment, attention bias modification, digital mental health treatment
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Attention Bias ModificationBehavioural
Each ABM trial begins with a central fixation cross for 1500ms, followed by a pair of POFA or IAPS stimuli (see Figure 3). POFA pairs will be presented for 3000ms, while IAPS pairs will be presented for 4500ms (due to the increased image complexity of IAPS images relative to POFA images). Longer stimulus duration times were selected based on evidence that attention biases for sad stimuli are prolonged in depression. Following offset of the images, either a single or double asterisk probe appears in the location of one of the images and will remain until a participant response or 10,000ms. In active ABM, the probe had an 80% probability of appearing in the location of the neutral stimulus. Investigators selected 80% rather than 100% to allow for computing attention bias during training and to facilitate task engagement. At the end of each ABM session, participants are provided feedback regarding their task performance relative to their last five sessions in a visual format.
Gamified Attention Bias ModificationBehavioural
Each trial consists of the fixation stage, facial cue stage, and response stage. At the fixation stage, an image appears (a colorful medallion) for 500 ms. The fixation appears randomly within a fixed rectangular field on the user's smartphone screen, and is always at the midpoint between the two face cues that will appear in the next stage. Next, after the cue disappears, two animated faces appear on the screen, one happy and one sad, with a 1000ms duration. Immediately after they disappear, a target probe (a trail) appears in the location of the happy face cue. The path remains (up to 3 seconds) until participants respond by tracing it starting from the point at which the face cue disappeared. They are instructed to quickly but accurately trace the path with their finger and receive visual and haptic feedback during tracing to indicate they are tracing accurately, followed by the path disappearing.
Sham Attention Bias ModificationBehavioural
Sham attention bias modification designed to match the active ABM condition in all respects except for the shifting attention away from negative stimuli in active attention bias modification.
| Study group | Role | What they receive |
|---|---|---|
| Sham Attention Bias Modification | Sham comparator | Sham and traditional ABM interventions will be identical in all respects with one critical exception. For sham ABM, after stimuli offset the target will appear with equal probability (50%) in the location of the neutral or the dysphoric stimulus. Receives: Behavioral: Sham Attention Bias Modification |
| Traditional Attention Bias Modification | Active comparator | This ABM variant is a web-based program delivered to participants via a computer. It presents pairs of stimuli to the right and left visual fields from two stimulus categories: sad or neutral facial expressions from the Pictures of Facial Affect (POFA) collection and dysphoric or neutral scenes from or from the International Affective Picture System (IAPS) collection. Receives: Behavioral: Traditional Attention Bias Modification |
| Gamified Attention Bias Modification | Experimental | This ABM variant will be completed on participants' mobile devices (iOS or Android). During app use, they will be presented with sad-happy stimulus pairs followed by target probes (tracing a path) always appearing at the happy stimulus location. Receives: Behavioral: Gamified Attention Bias Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
QIDS (Quick Inventory of Depression Symptoms) SR-16
The Quick Inventory of Depressive Symptoms (QIDS) is a 16-item measure (self-report and clinician-rated versions) for adults with depression with solid psychometric properties and substantial data supporting sensitivity to change. The QIDS assesses the criterion domains used to diagnose a major depressive disorder.
The participant must score a minimum of 13 on the QIDS-SR at the baseline assessment to qualify for participation. Total QIDS scores range from 0 to 27, with higher scores reflecting greater severity of depression, and thus, worst outcomes for our study.
Measured: Screening, Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Secondary outcomes (5)
Sheehan Disability Scale (SDS)
Self-report measure of symptom-related disability. SDS total score ranges from 0 (unimpaired) to 30 (highly impaired). Higher scores mean a worse outcome.
Measured: Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Snaith-Hamilton Pleasure Scale (SHAPS)
Self-report measure of anhedonia severity. SHAPS total score ranges from 0 to 14, with higher scores meaning worse outcomes.
Measured: Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Hamilton Depression Rating Scale (HAM-D)
Interviewer-rated measure of depression symptom severity. Scoring for this assessment can range from a minimum total score of 0 (least severe) and a maximum score of 52 (most severe). Higher scores mean worse outcomes.
Measured: Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Generalized Anxiety Disorder (GAD-7)
Self-report measure of anxiety symptom severity. GAD-7 total score for the seven items ranges from 0 to 21, with higher scores indicating worse outcomes.
Measured: Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Perseverative Thinking Questionnaire (PTQ)
A content-independent measures of repetitive negative thinking. PTQ total score for 15 items ranges from 0 to 60, with higher scores indicating worse outcomes.
Measured: Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 May 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Arcade Therapeutics
- Responsible party
- Sponsor
- Investigators
- Christopher G Beevers, PhD, Principal investigator, UT Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361095
- Sponsor's protocol ID
- R01GABM
- Status last verified
- May 2025
- First submitted
- 1 Apr 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will share data via the NDAR and code via the Texas Data Repository (https://dataverse.tdl.org/dataverse/mdl). The data is expected to become available at the end of the trial (\~ 5 years from now). Qualified researchers, as determined by the NIH's NDAR, will have access to the data. Anyone can access the code. The Study Protocol will be shared via a publication in a protocol journal within the next year.
Publications
Fadrigon B, Tseng A, Weisenburger RL, Levihn-Coon A, McNamara ME, Shumake J, Smits JAJ, Dennis-Tiwary TA, Beevers CG. Efficacy of traditional and gamified attention bias modification for depression: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2025 Feb;149:107797. doi: 10.1016/j.cct.2024.107797. Epub 2024 Dec 24.
PubMed 39725004
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmatory Efficacy Trial of a Traditional vs. Gamified Attention Bias Modification for Depression
- ClinicalTrials.gov ID
- NCT06361095
- Acronym / sponsor ID
- R01GABM
- Conditions
- Depression
- Keywords
- depression treatment, attention bias modification, digital mental health treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Arcade Therapeutics
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 11 Apr 2024 (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 clinical trial is to compare the efficacy of two related, but different ABM (Attention Biased Modification) treatments for depression in adults with elevated symptoms of depression. The main aims are:
- Aim 1:examine whether gamified ABM leads to greater change in the primary and secondary outcomes than sham ABM
- Aim 1: establish that gamified ABM is at least as effective as traditional ABM.
- Aim 2: identify moderators of ABM efficacy and mechanisms responsible for its efficacy.
- Aim 3: Identify the durability of ABM on depression symptoms during short-term follow-up
Participants will complete self-report questionnaires, complete eye-tracking tasks, and be clinically assessed through interviews by clinician researchers.
If there is a comparison group: Researchers will compare sham, traditional, and gamified treatment groups to see if they moderate symptoms of depression.
Detailed description
The overall goal of this project is to conduct a well-powered confirmatory efficacy trial comparing a gamified, attention bias modification (ABM) mobile application and traditional ABM to sham ABM among adults with elevated symptoms of depression. The proposed R01 efficacy trial follows the NIMH intervention development sequence as it builds upon prior NIMH-funded experimental therapeutics work, specifically R21MH092430 "Attention training for Major Depressive Disorder" and R33MH109600 "Development of attention bias modification for depression". This prior work demonstrates that active ABM engages and alters negative attention bias and there is a preliminary efficacy signal that ABM reduces depression. Although traditional ABM is efficacious for the treatment of depression, "gamified" forms of ABM have the potential to be more accessible and engaging than traditional ABM. Pilot work suggests that a gamified ABM can reduce negative affect; however, its effectiveness for depression has not yet been established. Thus, investigators are proposing to conduct a well-powered, confirmatory efficacy trial to determine ABM's potential for the treatment of depression. In Aim 1, the investigators will examine the efficacy of ABM in a large sample of adults (N = 600) with elevated symptoms of depression. The investigators hypothesize that gamified and traditional ABM will lead to significantly greater reductions in self-reported and interviewer-rated depression symptoms than sham ABM. The investigators further hypothesize that traditional ABM will be non-inferior to gamified ABM (treatment superiority between the ABM conditions will also be tested). In Aim 2, the investigators will examine putative moderators and mediators of ABM. Based on ABM research with anxious populations, it is predicted that people with a strong initial attentional bias for sad stimuli will experience greater reductions in depression in response to either gamified or traditional ABM than sham ABM. In terms of mediation, compared to sham ABM, the investigators hypothesize that gamified and traditional ABM will: (1) decrease negative attentional bias measured behaviorally with reliable eye tracking methods; (2) significantly reduce depression; and (3) improve depression symptoms via their influence on negative attentional bias. Selection of the putative mediators is informed by our prior R33 ABM trial, where it was found that gaze bias away from sad stimuli mediated the effect of traditional ABM on depression symptom change. In Aim 3, an exploratory aim, the investigators will estimate the durability of ABM by collecting post-treatment symptom data 1-, 2-, 3-, and 6-months after ABM completion. Symptom change and reliable recovery across a six-month follow-up period will be estimated. Currently, the durability of ABM effects for depression is unknown, as few well-powered ABM studies for depression have obtained follow-up data. This trial would provide the most definitive data to date regarding whether ABM for depression is a promising treatment for depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham Attention Bias Modification | Sham comparator | Behavioral: Sham Attention Bias ModificationSham and traditional ABM interventions will be identical in all respects with one critical exception. For sham ABM, after stimuli offset the target will appear with equal probability (50%) in the location of the neutral or the dysphoric stimulus. |
| Traditional Attention Bias Modification | Active comparator | Behavioral: Traditional Attention Bias ModificationThis ABM variant is a web-based program delivered to participants via a computer. It presents pairs of stimuli to the right and left visual fields from two stimulus categories: sad or neutral facial expressions from the Pictures of Facial Affect (POFA) collection and dysphoric or neutral scenes from or from the International Affective Picture System (IAPS) collection. |
| Gamified Attention Bias Modification | Experimental | Behavioral: Gamified Attention Bias ModificationThis ABM variant will be completed on participants' mobile devices (iOS or Android). During app use, they will be presented with sad-happy stimulus pairs followed by target probes (tracing a path) always appearing at the happy stimulus location. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provided informed consent
- Fluent in English
- Scored 13 or greater on the QIDS-SR at the baseline assessment
- Between the ages of 18 to 70
- Have had no changes in medication and dosage in the past 12 weeks (if currently on antidepressant medication)
Key exclusion criteria (5 listed)
- Reported suicidal behavior or significant suicidal ideation within the past six months using the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Met criteria for current or past bipolar or psychotic disorders
- Current (i.e., within the past 12 months) substance use disorders of moderate or greater severity on the Mini International Neuropsychiatric Interview (MINI)
- Currently taking opioid analgesics or systemic corticosteroid use as these medications
- Currently receiving psychotherapy
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 |
|---|---|---|
| Traditional Attention Bias ModificationEach ABM trial begins with a central fixation cross for 1500ms, followed by a pair of POFA or IAPS stimuli (see Figure 3). POFA pairs will be presented for 3000ms, while IAPS pairs will be presented for 4500ms (due to the increased image complexity of IAPS images relative to POFA images). Longer stimulus duration times were selected based on evidence that attention biases for sad stimuli are prolonged in depression. Following offset of the images, either a single or double asterisk probe appears in the location of one of the images and will remain until a participant response or 10,000ms. In active ABM, the probe had an 80% probability of appearing in the location of the neutral stimulus. Investigators selected 80% rather than 100% to allow for computing attention bias during training and to facilitate task engagement. At the end of each ABM session, participants are provided feedback regarding their task performance relative to their last five sessions in a visual format. | Behavioural | Traditional Attention Bias Modification |
| Gamified Attention Bias ModificationEach trial consists of the fixation stage, facial cue stage, and response stage. At the fixation stage, an image appears (a colorful medallion) for 500 ms. The fixation appears randomly within a fixed rectangular field on the user's smartphone screen, and is always at the midpoint between the two face cues that will appear in the next stage. Next, after the cue disappears, two animated faces appear on the screen, one happy and one sad, with a 1000ms duration. Immediately after they disappear, a target probe (a trail) appears in the location of the happy face cue. The path remains (up to 3 seconds) until participants respond by tracing it starting from the point at which the face cue disappeared. They are instructed to quickly but accurately trace the path with their finger and receive visual and haptic feedback during tracing to indicate they are tracing accurately, followed by the path disappearing. | Behavioural | Gamified Attention Bias Modification |
| Sham Attention Bias ModificationSham attention bias modification designed to match the active ABM condition in all respects except for the shifting attention away from negative stimuli in active attention bias modification. | Behavioural | Sham Attention Bias Modification |
Primary outcome
QIDS (Quick Inventory of Depression Symptoms) SR-16
Time frame: Screening, Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
The Quick Inventory of Depressive Symptoms (QIDS) is a 16-item measure (self-report and clinician-rated versions) for adults with depression with solid psychometric properties and substantial data supporting sensitivity to change. The QIDS assesses the criterion domains used to diagnose a major depressive disorder. The participant must score a minimum of 13 on the QIDS-SR at the baseline assessment to qualify for participation. Total QIDS scores range from 0 to 27, with higher scores reflecting greater severity of depression, and thus, worst outcomes for our study.
5 secondary outcomes
Sheehan Disability Scale (SDS)
Time frame: Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Hamilton Depression Rating Scale (HAM-D)
Time frame: Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Generalized Anxiety Disorder (GAD-7)
Time frame: Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Perseverative Thinking Questionnaire (PTQ)
Time frame: Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 39725004Fadrigon B, Tseng A, Weisenburger RL, Levihn-Coon A, McNamara ME, Shumake J, Smits JAJ, Dennis-Tiwary TA, Beevers CG. Efficacy of traditional and gamified attention bias modification for depression: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2025 Feb;149:107797. doi: 10.1016/j.cct.2024.107797. Epub 2024 Dec 24.
- Individual participant dataSharing planned: Yes. Investigators will share data via the NDAR and code via the Texas Data Repository (https://dataverse.tdl.org/dataverse/mdl). The data is expected to become available at the end of the trial (~ 5 years from now). Qualified researchers, as determined by the NIH's NDAR, will have access to the data. Anyone can access the code. The Study Protocol will be shared via a publication in a protocol journal within the next year.
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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.
Christopher G Beevers, PhD principal investigator
UT Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Traditional Attention Bias Modification and Gamified Attention Bias Modification in people with Depression, run by University of Texas at Austin 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 15 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher G Beevers, PhD (5124717557, beevers@utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QIDS (Quick Inventory of Depression Symptoms) SR-16 (time frame: Screening, Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06361095, which also lists 1 linked publication.
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 15 Sep 2025.