Borderline Personality DisorderPhase 4ROSESNCT06018727
Role Of Sensitivity to neuroEndocrine Systems in Social Decisions
A Phase 4 study testing Hydrocortisone and Yohimbine in people with Borderline Personality Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this research study is to investigate how personality traits and neuroendocrine systems relate to decision-making patterns in individuals 18-45 years old. The main question it aims to answer is how neuroendocrine activity impacts decision-making. This study has two components. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Hydrocortisone and Yohimbine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2024to Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Borderline Personality Disorder (BPD) group:
- Score of 38 or higher on PAI-BOR
- Participants in the BPD group will be primarily recruited from the two DEPENd lab studies that maintain large samples of BPD participants. To ensure maximal similarity between BPD participants recruited from other DEPENd lab studies and BPD participants recruited through other recruitment sources, the investigators will use the same criteria for the BPD group in the ROSES study as the criteria used in the other DEPENd lab studies. BPD participants in the two DEPENd lab studies from which the investigators will be recruiting must meet the following criteria:
- 3+ BPD symptoms, one of which must be affective instability, per clinical interview
- Participants must score at least 80 on the Reynolds Intellectual Screening Test (RIST).
- Matched Control (MC) group:
Show all 16Show fewer
- Score of 12 or lower on PAI-BOR
- Score below 50th percentile on WHODAS
- Combined Inclusion Criteria:
- Ages 18-45
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Willingness to participate in all components of the study
- Access to necessary resources for participating in the virtual Session 1 (i.e., computer, smartphone, internet access)
- Participants must be able to speak, understand and read English.
- Participants must have at least 20/40 visual acuity (correct or uncorrected).
Who cannot join
- Current use of medications that interact adversely with yohimbine
- Iobenguane radiopharmaceutical products
- Current use of medications that interact adversely with hydrocortisone
- Aldesleukin
- Bacillus Calmette-Guérin (BCG) Products
- Cladribine
Show all 55Show fewer
- Dengue Tetravalent Vaccine
- Desmopressin
- Indium 111 Capromab Pendetide
- Macimorelin
- Mifamurtide
- MiFEPRIStone
- Natalizumab
- Pimecrolimus:
- Ruxolitinib (Topical)
- Tacrolimus (Topical)
- Talimogene Laherparepvec
- Tertomotide
- Phenytoin
- Rifampin
- Troleandomycin
- Ketoconazole
- High-dose aspirin (>30 mg/kg/day)
- Contraindicated medical conditions of yohimbine
- Renal dysfunction
- Hepatic dysfunction
- Heart failure
- Psychotic Disorder or psychosis
- Hypotension
- Diabetes
- Heart disease
- Kidney disease
- Liver disease
- Nervous disorder
- Gastric ulcer
- Duodenal ulcer
- Contraindicated medical conditions of hydrocortisone
- Hypersensitivity to hydrocortisone or any component of the formulation
- Systemic fungal infections
- Latent Tuberculosis, Tuberculosis reactivity, active Tuberculosis
- Cardiovascular disease
- Diabetes
- Gastrointestinal diseases
- Diverticulitis ii. Fresh intestinal anastomoses iii. Active or latent peptic ulcer iv. Ulcerative colitis v. Abscess vi. Renal insufficiency vii. Other pyogenic infection g. Hepatic impairment h. Kidney impairment i. Myasthenia gravis j. Osteoporosis k. Pheochromocytoma l. Seizure disorders m. Septic shock or sepsis syndrome n. Systemic sclerosis o. Thyroid disease p. Strongyloides (threadworm) infestation q. Ocular herpes simplex r. Hypertension
- Given a live vaccine within 2 weeks of completing Visit 1. Recent administration of the following vaccines are specifically contraindicated for hydrocortisone:
- Typhoid Vaccine
- Yellow Fever Vaccine
- Poliovirus Vaccine (Live/Trivalent/Oral)
- Rubella- or Varicella-Containing Live Vaccines
- Have a current infection
- Pregnancy
- Individuals lactating
- Recent antihypertensive agents
- History of psychotic disorder, Bipolar I disorder, autism spectrum disorder, reactive attachment disorder, pervasive developmental disorder, motor disorder, head injury, mental retardation, neurological disorder, or current substance dependence
- Family history of Bipolar I disorder in a first degree relative.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
The purpose of this research study is to investigate how personality traits and neuroendocrine systems relate to decision-making patterns in individuals 18-45 years old. The main question it aims to answer is how neuroendocrine activity impacts decision-making.
This study has two components. First, there will be an online session that participants complete to consent into the study, complete self-report surveys and a cognitive assessment, and confirm their eligibility for the second part of the study. If eligible to continue, participants will complete one in-person experiment session, during which they will complete self-report measures and a decision-making task. During the in-person session, participants will be randomly assigned (like flipping a coin) to ingest either a placebo (non-active) or the combination of hydrocortisone and yohimbine.
Read the detailed description
This study has two components. First, there will be a 60 minute online session. During this session, participants will first be asked to complete the informed consent process, a demographics and contact form, a series of questionnaires, a working memory assessment, and a HIPAA authorization. Researchers will also conduct a brief interview about the participant's medical history (including questions about mood, personality, and symptoms of borderline personality disorder), which is used to assess eligibility for participation in the study.
If eligible to continue, participants will complete one 90 minute in-person experiment session. During the in-person session, participants will be randomly assigned (like flipping a coin) to ingest either a placebo (non-active) or the combination of hydrocortisone and yohimbine. Ingesting hydrocortisone and yohimbine will increase participants' neuroendocrine (hormone) levels, which naturally become elevated in response to stress. After ingesting either the placebo or hydrocortisone plus yohimbine, participants will complete a series of questionnaires on a computer as well as an online decision-making task. While completing the computer task, participants' heart rate and pupil size activity will be monitored using an ECG monitor and an eye tracker. Three salivary samples will also be collected during this session: one immediately before participants ingest the placebo or hydrocortisone/yohimbine combination and two immediately before and after participants complete the computer game. These salivary samples will be collected, stored, then assayed, a process that allows us to measure participants' cortisol levels, a hormone important for the body's stress response.
- Conditions
- Borderline Personality Disorder
- Being tested
- Hydrocortisone, Yohimbine, Placebo
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Also called Cortef
Hydrocortisone 20 mg capsule will be administered orally.
YohimbineDietary supplement
Also called Yohimbine Hydrochloride
Yohimbine 20 mg capsule will be administered orally.
PlaceboDrug
Also called Sugar pill
Two placebos will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone + Yohimbine | Experimental | Participants will ingest hydrocortisone and yohimbine during Session 2 approximately 10 minutes into the session. Receives: Drug: Hydrocortisone; Dietary Supplement: Yohimbine |
| Placebo + Placebo | Placebo comparator | Participants will orally ingest two placebos during Session 2 approximately 10 minutes into the session. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal-directed decision-making in the Social Decision Tree Task (SDTT)
Measured by choice behavior in SDTT, which is based on the decision tree framework. After each action, participants receive feedback about the effect of that action and the extent to which it added to or took away from their points. If participants make a given choice, the subsequent actions that they can choose are different than if they were to initially make a different choice.
An action in SDTT is goal-directed if the possible net gain an individual can earn before the end of the current epoch (a "day" in the SDTT) is equal to or higher than the amount they could gain by choosing the alternative action. The investigators will subset trials so that 1 is coded as choosing the immediately valuable action at the expense of the optimal and 0 is coded as choosing the optimal at the expense of the immediately valuable action. This outcome variable is binary. An action is defined as social if it is paired with a visual cue with a face on it and non-social if not.
Measured: Collected for 30 minutes ~1 hour into Session 2, which takes place on approximately Day 7 of the study
Change in salivary cortisol
The investigators will collect a saliva sample immediately before participants ingest the drugs (or placebos, if in the control condition). They will collect a second saliva sample 45 minutes after the drug (or placebo) ingestion. They will measure cortisol levels in both samples through an assay. The investigators will calculate the change in salivary cortisol by subtracting the measured cortisol in the first saliva sample (collected pre-drug/placebo ingestion) from the measured cortisol in the second saliva sample (collected 45 minutes after the drug/placebo ingestion). Salivary cortisol is measured as nmol/L. Salivary cortisol expected to generally be below 200 nmol/L.
Measured: Collected immediately before the drug/placebo administration (~5 minutes into the session) and 45 minutes after the drug/placebo administration (~50 minutes into the session) in Session 2, which takes place on approximately Day 7
Pupil diameter during SDTT
The outcome will be measured using eye tracking technology.
Measured: Collected for 30 minutes ~1 hour into Session 2, which takes place on approximately Day 7 of the study
Secondary outcomes (3)
Change in valence, measured via the affect grid
Change in valence will be assessed through the affect grid. Participants will be presented with a 9x9 grid. The vertical dimension of the grid represents arousal, while horizontal dimension of the grid represents valence. The left side of the grid represents negative valence and the right side represents positive valence. Participants will click a square on the grid with their computer mouse to indicate their current affect. Their valence will be measured before the drug/placebo ingestion and 45 minutes after the drug/placebo administration. The minimum valence score is -4, representing extreme negative valence, and the maximum valence score is 4, representing extreme positive valence. The largest change in valence value is 8 (the maximum positive change in valence from time point 1 to time point 2). The smallest change in valence value is -8 (the maximum negative change in valence from time point 1 to time point 2). If no change in valence, the score will be 0.
Measured: Collected immediately before the first saliva collection in Session 2 (~5 minutes into the session) and 45 minutes after the second saliva collection in Session 2 (~50 minutes into the session), which takes place on approximately Day 7
Change in arousal, measured via the affect grid
Change in arousal will be assessed through the affect grid. Participants will be presented with a 9x9 grid. The vertical dimension of the grid represents arousal, while horizontal dimension of the grid represents valence. The top of the grid represents high arousal and the bottom represents low arousal. Participants will click a square on the grid with their computer mouse to indicate their current affect. Their arousal will be measured before the drug/placebo ingestion and 45 minutes after the drug/placebo administration. The minimum arousal score is -4, representing extremely low arousal, and the maximum arousal score is 4, representing extremely high arousal. The largest change in arousal value is 8 (the maximum positive change in arousal from time point 1 to time point 2). The smallest change in arousal value is -8 (the maximum negative change in arousal from time point 1 to time point 2). If no change in arousal, the score would be 0.
Measured: Collected immediately before the first saliva collection in Session 2 (~5 minutes into the session) and 45 minutes after the second saliva collection in Session 2 (~50 minutes into the session), which takes place on approximately Day 7
Change in stress, measured via the subjective stress scale
Will be assessed via self-report using the one-item subjective stress scale. The scale ranges from 0 to 10. High values indicate more stress, whereas low values indicate less stress.
Measured: Collected immediately before the first saliva collection in Session 2 (~5 minutes into the session) and 45 minutes after the second saliva collection in Session 2 (~50 minutes into the session), which takes place on approximately Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: Changed study design and it is no longer a clinical trial.
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 Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael N Hallquist, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018727
- Sponsor's protocol ID
- 22-1839
- Acronym
- ROSES
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).
Publications
Huys QJ, Eshel N, O'Nions E, Sheridan L, Dayan P, Roiser JP. Bonsai trees in your head: how the pavlovian system sculpts goal-directed choices by pruning decision trees. PLoS Comput Biol. 2012;8(3):e1002410. doi: 10.1371/journal.pcbi.1002410. Epub 2012 Mar 8.
PubMed 22412360
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Sensitivity to neuroEndocrine Systems in Social Decisions
- ClinicalTrials.gov ID
- NCT06018727
- Acronym / sponsor ID
- ROSES / 22-1839
- Conditions
- Borderline Personality Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changed study design and it is no longer a clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 31 Aug 2023 (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 purpose of this research study is to investigate how personality traits and neuroendocrine systems relate to decision-making patterns in individuals 18-45 years old. The main question it aims to answer is how neuroendocrine activity impacts decision-making.
This study has two components. First, there will be an online session that participants complete to consent into the study, complete self-report surveys and a cognitive assessment, and confirm their eligibility for the second part of the study. If eligible to continue, participants will complete one in-person experiment session, during which they will complete self-report measures and a decision-making task. During the in-person session, participants will be randomly assigned (like flipping a coin) to ingest either a placebo (non-active) or the combination of hydrocortisone and yohimbine.
Detailed description
This study has two components. First, there will be a 60 minute online session. During this session, participants will first be asked to complete the informed consent process, a demographics and contact form, a series of questionnaires, a working memory assessment, and a HIPAA authorization. Researchers will also conduct a brief interview about the participant's medical history (including questions about mood, personality, and symptoms of borderline personality disorder), which is used to assess eligibility for participation in the study.
If eligible to continue, participants will complete one 90 minute in-person experiment session. During the in-person session, participants will be randomly assigned (like flipping a coin) to ingest either a placebo (non-active) or the combination of hydrocortisone and yohimbine. Ingesting hydrocortisone and yohimbine will increase participants' neuroendocrine (hormone) levels, which naturally become elevated in response to stress. After ingesting either the placebo or hydrocortisone plus yohimbine, participants will complete a series of questionnaires on a computer as well as an online decision-making task. While completing the computer task, participants' heart rate and pupil size activity will be monitored using an ECG monitor and an eye tracker. Three salivary samples will also be collected during this session: one immediately before participants ingest the placebo or hydrocortisone/yohimbine combination and two immediately before and after participants complete the computer game. These salivary samples will be collected, stored, then assayed, a process that allows us to measure participants' cortisol levels, a hormone important for the body's stress response.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone + Yohimbine | Experimental | Drug: Hydrocortisone, Dietary Supplement: YohimbineParticipants will ingest hydrocortisone and yohimbine during Session 2 approximately 10 minutes into the session. |
| Placebo + Placebo | Placebo comparator | Drug: PlaceboParticipants will orally ingest two placebos during Session 2 approximately 10 minutes into the session. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Score of 38 or higher on PAI-BOR
- Participants in the BPD group will be primarily recruited from the two DEPENd lab studies that maintain large samples of BPD participants. To ensure maximal similarity between BPD participants recruited from other DEPENd lab studies and BPD participants recruited through other recruitment sources, the investigators will use the same criteria for the BPD group in the ROSES study as the criteria used in the other DEPENd lab studies. BPD participants in the two DEPENd lab studies from which the investigators will be recruiting must meet the following criteria:
- Score of 12 or lower on PAI-BOR
- Score below 50th percentile on WHODAS
- Ages 18-45
Key exclusion criteria (55 listed)
- Current use of medications that interact adversely with yohimbine
- Current use of medications that interact adversely with hydrocortisone
- Contraindicated medical conditions of yohimbine
- Contraindicated medical conditions of hydrocortisone
- Given a live vaccine within 2 weeks of completing Visit 1. Recent administration of the following vaccines are specifically contraindicated for hydrocortisone:
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 |
|---|---|---|
| HydrocortisoneAlso: CortefHydrocortisone 20 mg capsule will be administered orally. | Drug | Hydrocortisone + Yohimbine |
| YohimbineAlso: Yohimbine HydrochlorideYohimbine 20 mg capsule will be administered orally. | Dietary supplement | Hydrocortisone + Yohimbine |
| PlaceboAlso: Sugar pillTwo placebos will be administered orally. | Drug | Placebo + Placebo |
Primary outcome
Goal-directed decision-making in the Social Decision Tree Task (SDTT)
Time frame: Collected for 30 minutes ~1 hour into Session 2, which takes place on approximately Day 7 of the study
Measured by choice behavior in SDTT, which is based on the decision tree framework. After each action, participants receive feedback about the effect of that action and the extent to which it added to or took away from their points. If participants make a given choice, the subsequent actions that they can choose are different than if they were to initially make a different choice. An action in SDTT is goal-directed if the possible net gain an individual can earn before the end of the current epoch (a "day" in the SDTT) is equal to or higher than the amount they could gain by choosing the alternative action. The investigators will subset trials so that 1 is coded as choosing the immediately valuable action at the expense of the optimal and 0 is coded as choosing the optimal at the expense of the immediately valuable action. This outcome variable is binary. An action is defined as social if it is paired with a visual cue with a face on it and non-social if not.
Change in salivary cortisol
Time frame: Collected immediately before the drug/placebo administration (~5 minutes into the session) and 45 minutes after the drug/placebo administration (~50 minutes into the session) in Session 2, which takes place on approximately Day 7
The investigators will collect a saliva sample immediately before participants ingest the drugs (or placebos, if in the control condition). They will collect a second saliva sample 45 minutes after the drug (or placebo) ingestion. They will measure cortisol levels in both samples through an assay. The investigators will calculate the change in salivary cortisol by subtracting the measured cortisol in the first saliva sample (collected pre-drug/placebo ingestion) from the measured cortisol in the second saliva sample (collected 45 minutes after the drug/placebo ingestion). Salivary cortisol is measured as nmol/L. Salivary cortisol expected to generally be below 200 nmol/L.
Pupil diameter during SDTT
Time frame: Collected for 30 minutes ~1 hour into Session 2, which takes place on approximately Day 7 of the study
The outcome will be measured using eye tracking technology.
3 secondary outcomes
Change in valence, measured via the affect grid
Time frame: Collected immediately before the first saliva collection in Session 2 (~5 minutes into the session) and 45 minutes after the second saliva collection in Session 2 (~50 minutes into the session), which takes place on approximately Day 7
Change in arousal, measured via the affect grid
Time frame: Collected immediately before the first saliva collection in Session 2 (~5 minutes into the session) and 45 minutes after the second saliva collection in Session 2 (~50 minutes into the session), which takes place on approximately Day 7
Change in stress, measured via the subjective stress scale
Time frame: Collected immediately before the first saliva collection in Session 2 (~5 minutes into the session) and 45 minutes after the second saliva collection in Session 2 (~50 minutes into the session), which takes place on approximately Day 7
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Background: PubMed 22412360Huys QJ, Eshel N, O'Nions E, Sheridan L, Dayan P, Roiser JP. Bonsai trees in your head: how the pavlovian system sculpts goal-directed choices by pruning decision trees. PLoS Comput Biol. 2012;8(3):e1002410. doi: 10.1371/journal.pcbi.1002410. Epub 2012 Mar 8.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).
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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. This study is not recruiting at the moment.
Michael N Hallquist, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone and Yohimbine in people with Borderline Personality Disorder, run by University of North Carolina, Chapel Hill 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 16 inclusion and 55 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: withdrawn, as of the sponsor's last update on 5 Jun 2024. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal-directed decision-making in the Social Decision Tree Task (SDTT) (time frame: Collected for 30 minutes ~1 hour into Session 2, which takes place on approximately Day 7 of the study). The study lists 3 primary outcomes in all. 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 NCT06018727, 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 5 Jun 2024.