Early PsychosisSTEP2NCT07834203
State Representation in Early Psychosis 2
An observational study of Early Psychosis and Psychosis, run by University of Minnesota at 2 sites in United States.
Trial summary
This observational study will examine behavioral and electroencephalography measures related to state representation in individuals with early psychosis and healthy control participants. Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Psychosis, Psychosis, Schizophrenia
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2025to 30 Jun 2030
- Phase
- Observational
- 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 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population includes individuals with early psychosis and demographically similar healthy control participants. Early psychosis participants will have a clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis. Healthy control participants will be recruited from the community and must not meet DSM-5 criteria for psychotic or bipolar disorder or have a first-degree family history of psychotic or bipolar disorder. Participants will be 15 to 45 years old and will complete clinical interviews, self-report measures, cognitive assessments, computerized behavioral tasks, and EEG assessments.
Who may be able to join
- All participants:
- Aged between 15 and 45 years
- English proficiency, as determined by staff observation and participant self-report
- Estimated IQ at or above 70, as estimated by cognitive assessments
- Estimated visual acuity at 20/40, as estimated by the visual acuity test
- Early Psychosis participants:
Show all 9Show fewer
- Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis
- Age 35 years or younger, or age 36 to 45 years with onset of psychotic symptoms within the previous 5 years
- Achieved clinical stability, defined as outpatient status for at least one month prior to study participation
Who cannot join
- All participants:
- Unable or unwilling to provide informed consent
- Unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member
- Illiterate
- Previous clinically significant head injury or prolonged unconsciousness, as determined by the investigators
- Meets criteria for severe substance or alcohol use disorder within 3 months of behavioral assessment
Show all 15Show fewer
- Presence of any major medical condition that, in the opinion of the investigators, would impede participation or put the participant at additional risk
- Has participated in significant formal cognitive training programs, as determined by the investigators
- Meets criteria for clinical risk of suicidal behavior
- Early Psychosis participants:
- Presence of a major neurological disorder
- Healthy Control participants:
- Meets DSM-5 criteria for psychotic or bipolar disorder
- Has a first-degree family history of psychotic or bipolar disorder
- Presence of a major neurological disorder
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, 2 recruiting
- Recruiting
University of Minnesota Ambulatory Research Center
Minneapolis, Minnesota, 55455
Grace Owens, 612-741-2826, owens387@umn.edu
Scott Sponheim, PhD, LP
- Recruiting
University of Minnesota Department of Psychology
Minneapolis, Minnesota, 55455
Grace Owens, 612-741-2826, owens387@umn.edu
Scott Sponheim, PhD, LP
About this study
This observational study will examine behavioral and electroencephalography measures related to state representation in individuals with early psychosis and healthy control participants.
Participants will complete clinical interviews, self-report measures, cognitive assessments, computerized behavioral tasks, and EEG assessments. The study will evaluate performance and computed parameters from the Translational Orientation Pattern Expectancy task and Translational Bandit Task, along with EEG variables related to cognitive control, reward processing, and neural synchrony.
The study aims to better understand heterogeneity in early psychosis and identify neurocognitive and neurophysiologic markers that may inform future precision psychiatry approaches.
Read the detailed description
State Representation in Early Psychosis 2 is an observational study of individuals with early psychosis and healthy control participants. The study is part of an NIH Silvio O. Conte Center for Translational Mental Health Research grant and is designed to examine behavioral and neural markers of state representation processes in early psychosis.
The study will enroll individuals with early psychosis and demographically similar healthy controls. Participants will complete interviews, self-report measures, behavioral tasks, cognitive assessments, and electroencephalography assessments. The study focuses on computational and EEG measures related to state estimation, state maintenance, and state learning.
Participants will complete variants of two computerized tasks: the Translational Orientation Pattern Expectancy task and the Translational Bandit Task. EEG will be collected while participants complete these tasks and during resting state. EEG variables of interest include P300, reward positivity, phase synchrony, spectral power density slope, and prefrontal/parietal theta.
Clinical and functional measures will also be collected, including measures of psychiatric symptoms, functioning, motivation, pleasure, discrimination, disability, depression, anxiety, and general cognitive ability. The study will compare early psychosis participants with healthy control participants and evaluate how behavioral, computational, EEG, cognitive, clinical, and functional measures relate to heterogeneity in early psychosis.
- Conditions
- Early Psychosis, Psychosis, Schizophrenia, Bipolar Disorder With Psychosis, Schizoaffective Disorder
- Keywords
- STEP2, State representation, Electroencephalography, Psychosis
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early Psychosis Participants | Participants with a clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis. Participants will complete clinical interviews, self-report measures, cognitive/computerized tasks, and EEG assessments. | |
| Healthy Control Participants | Community control participants without psychotic or bipolar disorder and without a first-degree family history of psychotic or bipolar disorder. Participants will complete clinical interviews, self-report measures, cognitive/computerized tasks, and EEG assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined TOPX and TBT State Representation Parameter Score
Performance and computed parameters from the Translational Orientation Pattern Expectancy task and Translational Bandit Task will be combined to evaluate state estimation, state maintenance, and state learning processes. The Translational Orientation Pattern Expectancy task is a cognitive control task used to evaluate dysregulated expectancy through responses to expected and unexpected stimuli. The Translational Bandit Task is a reward learning task used to evaluate responses to rewards. Together, task-derived parameters will be combined into model-derived parameter scores reflecting state estimation, state maintenance, and state learning.
Unit: model-derived parameter score
Measured: Baseline study assessment, up to 8 weeks
P300 Amplitude During AX-CPT Task
P300 will be assessed during the AX-CPT task as a parietally maximal positive-going event-related potential component occurring approximately 300 to 600 milliseconds after stimulus presentation. Cue-locked P300 responses to A versus B cues and probe-locked P300 responses to AX versus AY probes will be used to assess attention allocation and context/state representation during proactive and reactive cognitive control.
Unit: Microvolts
Measured: Baseline study assessment, up to 8 weeks
Reward Positivity Amplitude During Translational Bandit Task
Reward positivity will be assessed during the Translational Bandit Task as a frontocentrally maximal event-related potential component occurring approximately 250 to 350 milliseconds after reward versus non-reward feedback. Reward positivity will be used to assess reward sensitivity and reinforcement learning.
Unit: Microvolts
Measured: Baseline study assessment, up to 8 weeks
Resting-State EEG Phase Synchrony
Phase synchrony will be assessed during resting-state EEG using measures of the consistency of phase relationships between electrode sites, such as phase-locking value or weighted phase-lag index. Resting-state EEG will include eyes-closed and eyes-open conditions and will be used to assess coordination of neural activity across distributed brain regions.
Unit: phase-locking value
Measured: Baseline study assessment, up to 8 weeks
Resting-State EEG Spectral Power Density Slope
The slope of spectral power density will be assessed during resting-state EEG as the aperiodic, 1/f-like component of the power spectrum. The slope will be estimated after separating periodic oscillatory activity from the aperiodic component and will be used to assess cortical excitation/inhibition balance and arousal state.
Unit: aperiodic exponent
Measured: Baseline study assessment, up to 8 weeks
Prefrontal and Parietal Theta Power
Prefrontal and parietal theta activity will be assessed using electroencephalography during computerized tasks and resting state as a neurophysiologic measure related to cognitive control and state representation.
Unit: decibels
Measured: Baseline study assessment, up to 8 weeks
Secondary outcomes (15)
Minnesota Symptoms Severity Questionnaire Score
Physical and mental well-being symptoms will be assessed using the 29-item Minnesota Symptoms Severity questionnaire. Items are scored from 1, absent, to 5, occurring nearly every day. Higher scores indicate higher frequency of physical and mental health symptoms.
Unit: points
Measured: Baseline study assessment, up to 8 weeks
Scale for the Assessment of Negative Symptoms Score
Negative symptoms will be assessed using the Scale for the Assessment of Negative Symptoms. Items are scored from 0, absent, to 5, severe. Higher scores indicate greater negative symptom severity.
Unit: points
Measured: Baseline study assessment, up to 8 weeks
Scale for the Assessment of Positive Symptoms Score
Positive symptoms will be assessed using the Scale for the Assessment of Positive Symptoms. Items are scored from 0, absent, to 5, severe. Higher scores indicate greater positive symptom severity.
Unit: points
Measured: Baseline study assessment, up to 8 weeks
Brief Psychiatric Rating Scale Score
Psychiatric symptoms will be assessed using the Brief Psychiatric Rating Scale. The scale assesses 24 psychiatric symptom constructs, with items scored from 1, absent, to 7, extremely severe. Higher scores indicate greater psychiatric symptom severity.
Unit: Points
Measured: Baseline study assessment, up to 8 weeks
Schizotypal Personality Questionnaire-Brief Revised Score
Schizotypal traits will be assessed using the 32-item Schizotypal Personality Questionnaire-Brief Revised. Items are scored from 0, strongly disagree, to 4, strongly agree. Higher scores indicate greater schizotypal trait severity.
Unit: Points
Measured: Baseline study assessment, up to 8 weeks
Intersectional Discrimination Index Score
Experiences of discrimination will be assessed using the 31-item Intersectional Discrimination Index. The measure uses multiple item response scales to assess experiences of, and worries about, discrimination. Higher scores indicate more frequent or more intense experiences or concerns related to discrimination.
Unit: Points
Measured: Baseline study assessment, up to 8 weeks
Motivation and Pleasure Scale-Self Report Score
Motivation and pleasure will be assessed using the 15-item Motivation and Pleasure Scale-Self Report. Items are scored from 0 to 4. Lower scores indicate greater deficits in motivation and pleasure.
Unit: Points
Measured: Baseline study assessment, up to 8 weeks
World Health Organization Disability Assessment Schedule Score
Disability will be assessed using the 15-item World Health Organization Disability Assessment Schedule. Items are scored from 1, none, to 5, extreme or cannot do. Higher scores indicate greater disability.
Unit: Points
Measured: Baseline study assessment, up to 8 weeks
Global Functioning Social Scale Score
Social functioning will be assessed using the Global Functioning Social scale. Scores range from 1, extreme social isolation, to 10, superior social functioning. Lower scores indicate worse social functioning.
Unit: Points
Measured: Baseline study assessment, up to 8 weeks
Test My Brain Matrix Reasoning Score
Fluid cognitive ability and nonverbal reasoning will be assessed using the Matrix Reasoning assessment from Test My Brain.
Unit: Points
Measured: Baseline study assessment, up to 8 weeks
Test My Brain Digit Symbol Matching Score
Processing speed and visual short-term memory will be assessed using the Digit Symbol Matching assessment from Test My Brain.
Unit: Points
Measured: Baseline study assessment, up to 8 weeks
Test My Brain Verbal Paired Associates Memory Score
Verbal memory and episodic memory will be assessed using the Verbal Paired Associates Memory assessment from Test My Brain.
Unit: points
Measured: Baseline study assessment, up to 8 weeks
Test My Brain Multiracial Emotion Recognition Score
Face emotion perception and emotion identification will be assessed using the Multiracial Emotion Recognition assessment from Test My Brain.
Unit: Points
Measured: Baseline study assessment, up to 8 weeks
Wechsler Test of Adult Reading Score
Verbal intelligence will be assessed using the Wechsler Test of Adult Reading. Unit: Points
Measured: Baseline study assessment, up to 8 weeks
Global Functioning Role Scale Score
Role functioning will be assessed using the Global Functioning Role scale. Scores range from 1, extremely poor role functioning, to 10, superior role functioning. Lower scores indicate worse occupational or role functioning.
Unit: Points
Measured: Baseline study assessment, up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start15 Oct 2025
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early PsychosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Scott Sponheim, PhD, LP, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834203
- Sponsor's protocol ID
- STUDY00024589
- Other IDs
- CON000000112940
- Acronym
- STEP2
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- State Representation in Early Psychosis 2
- ClinicalTrials.gov ID
- NCT07834203
- Acronym / sponsor ID
- STEP2 / STUDY00024589
- Conditions
- Early Psychosis, Psychosis, Schizophrenia, Bipolar Disorder With Psychosis, Schizoaffective Disorder
- Keywords
- STEP2, State representation, Electroencephalography, Psychosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 22 Sep 2026 (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.
This observational study will examine behavioral and electroencephalography measures related to state representation in individuals with early psychosis and healthy control participants.
Participants will complete clinical interviews, self-report measures, cognitive assessments, computerized behavioral tasks, and EEG assessments. The study will evaluate performance and computed parameters from the Translational Orientation Pattern Expectancy task and Translational Bandit Task, along with EEG variables related to cognitive control, reward processing, and neural synchrony.
The study aims to better understand heterogeneity in early psychosis and identify neurocognitive and neurophysiologic markers that may inform future precision psychiatry approaches.
Detailed description
State Representation in Early Psychosis 2 is an observational study of individuals with early psychosis and healthy control participants. The study is part of an NIH Silvio O. Conte Center for Translational Mental Health Research grant and is designed to examine behavioral and neural markers of state representation processes in early psychosis.
The study will enroll individuals with early psychosis and demographically similar healthy controls. Participants will complete interviews, self-report measures, behavioral tasks, cognitive assessments, and electroencephalography assessments. The study focuses on computational and EEG measures related to state estimation, state maintenance, and state learning.
Participants will complete variants of two computerized tasks: the Translational Orientation Pattern Expectancy task and the Translational Bandit Task. EEG will be collected while participants complete these tasks and during resting state. EEG variables of interest include P300, reward positivity, phase synchrony, spectral power density slope, and prefrontal/parietal theta.
Clinical and functional measures will also be collected, including measures of psychiatric symptoms, functioning, motivation, pleasure, discrimination, disability, depression, anxiety, and general cognitive ability. The study will compare early psychosis participants with healthy control participants and evaluate how behavioral, computational, EEG, cognitive, clinical, and functional measures relate to heterogeneity in early psychosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Psychosis Participants | – | –Participants with a clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis. Participants will complete clinical interviews, self-report measures, cognitive/computerized tasks, and EEG assessments. |
| Healthy Control Participants | – | –Community control participants without psychotic or bipolar disorder and without a first-degree family history of psychotic or bipolar disorder. Participants will complete clinical interviews, self-report measures, cognitive/computerized tasks, and EEG assessments. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population includes individuals with early psychosis and demographically similar healthy control participants. Early psychosis participants will have a clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis. Healthy control participants will be recruited from the community and must not meet DSM-5 criteria for psychotic or bipolar disorder or have a first-degree family history of psychotic or bipolar disorder. Participants will be 15 to 45 years old and will complete clinical interviews, self-report measures, cognitive assessments, computerized behavioral tasks, and EEG assessments.
Key inclusion criteria (9 listed)
- Aged between 15 and 45 years
- English proficiency, as determined by staff observation and participant self-report
- Estimated IQ at or above 70, as estimated by cognitive assessments
- Estimated visual acuity at 20/40, as estimated by the visual acuity test
- Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis
Key exclusion criteria (15 listed)
- Unable or unwilling to provide informed consent
- Unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member
- Illiterate
- Previous clinically significant head injury or prolonged unconsciousness, as determined by the investigators
- Meets criteria for severe substance or alcohol use disorder within 3 months of behavioral assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Combined TOPX and TBT State Representation Parameter Score
Time frame: Baseline study assessment, up to 8 weeks
Performance and computed parameters from the Translational Orientation Pattern Expectancy task and Translational Bandit Task will be combined to evaluate state estimation, state maintenance, and state learning processes. The Translational Orientation Pattern Expectancy task is a cognitive control task used to evaluate dysregulated expectancy through responses to expected and unexpected stimuli. The Translational Bandit Task is a reward learning task used to evaluate responses to rewards. Together, task-derived parameters will be combined into model-derived parameter scores reflecting state estimation, state maintenance, and state learning. Unit: model-derived parameter score
P300 Amplitude During AX-CPT Task
Time frame: Baseline study assessment, up to 8 weeks
P300 will be assessed during the AX-CPT task as a parietally maximal positive-going event-related potential component occurring approximately 300 to 600 milliseconds after stimulus presentation. Cue-locked P300 responses to A versus B cues and probe-locked P300 responses to AX versus AY probes will be used to assess attention allocation and context/state representation during proactive and reactive cognitive control. Unit: Microvolts
Reward Positivity Amplitude During Translational Bandit Task
Time frame: Baseline study assessment, up to 8 weeks
Reward positivity will be assessed during the Translational Bandit Task as a frontocentrally maximal event-related potential component occurring approximately 250 to 350 milliseconds after reward versus non-reward feedback. Reward positivity will be used to assess reward sensitivity and reinforcement learning. Unit: Microvolts
Resting-State EEG Phase Synchrony
Time frame: Baseline study assessment, up to 8 weeks
Phase synchrony will be assessed during resting-state EEG using measures of the consistency of phase relationships between electrode sites, such as phase-locking value or weighted phase-lag index. Resting-state EEG will include eyes-closed and eyes-open conditions and will be used to assess coordination of neural activity across distributed brain regions. Unit: phase-locking value
Resting-State EEG Spectral Power Density Slope
Time frame: Baseline study assessment, up to 8 weeks
The slope of spectral power density will be assessed during resting-state EEG as the aperiodic, 1/f-like component of the power spectrum. The slope will be estimated after separating periodic oscillatory activity from the aperiodic component and will be used to assess cortical excitation/inhibition balance and arousal state. Unit: aperiodic exponent
Prefrontal and Parietal Theta Power
Time frame: Baseline study assessment, up to 8 weeks
Prefrontal and parietal theta activity will be assessed using electroencephalography during computerized tasks and resting state as a neurophysiologic measure related to cognitive control and state representation. Unit: decibels
15 secondary outcomes
Minnesota Symptoms Severity Questionnaire Score
Time frame: Baseline study assessment, up to 8 weeks
Scale for the Assessment of Negative Symptoms Score
Time frame: Baseline study assessment, up to 8 weeks
Scale for the Assessment of Positive Symptoms Score
Time frame: Baseline study assessment, up to 8 weeks
Brief Psychiatric Rating Scale Score
Time frame: Baseline study assessment, up to 8 weeks
Schizotypal Personality Questionnaire-Brief Revised Score
Time frame: Baseline study assessment, up to 8 weeks
Intersectional Discrimination Index Score
Time frame: Baseline study assessment, up to 8 weeks
Motivation and Pleasure Scale-Self Report Score
Time frame: Baseline study assessment, up to 8 weeks
World Health Organization Disability Assessment Schedule Score
Time frame: Baseline study assessment, up to 8 weeks
Global Functioning Social Scale Score
Time frame: Baseline study assessment, up to 8 weeks
Test My Brain Matrix Reasoning Score
Time frame: Baseline study assessment, up to 8 weeks
Test My Brain Digit Symbol Matching Score
Time frame: Baseline study assessment, up to 8 weeks
Test My Brain Verbal Paired Associates Memory Score
Time frame: Baseline study assessment, up to 8 weeks
Test My Brain Multiracial Emotion Recognition Score
Time frame: Baseline study assessment, up to 8 weeks
Wechsler Test of Adult Reading Score
Time frame: Baseline study assessment, up to 8 weeks
Global Functioning Role Scale Score
Time frame: Baseline study assessment, up to 8 weeks
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 22 Sep 2026.
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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.
Scott Sponheim, PhD, LP principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Psychosis and Psychosis, run by University of Minnesota at 2 sites 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 9 inclusion and 15 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Grace Owens ((612) 741-2826, step2study@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined TOPX and TBT State Representation Parameter Score (time frame: Baseline study assessment, up to 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.