Depression, AnxietyPhase 4NCT06004115
Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression
A Phase 4 study testing Lorazepam in people with Depression, Anxiety and Fear, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
This mechanistic study uses an anti anxiety drug and brain imaging to study the threat processing system and associated brain circuits in people with depression, anxiety disorders and comorbid depression and anxiety disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety, Fear, Depression
- What is being tested?
- Lorazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2023to 31 Dec 2027
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects:
- Female or male sex assigned at birth;
- Age 18-65;
- Normal or corrected to normal vision/hearing, as protocol elements may not be valid otherwise;
- Fluent English speaker, capable of providing written informed consent
- MDD and AD-MDD subjects:
Show all 11Show fewer
- Current major depressive episode assessed by clinician with guidance from the MINI;
- Minimum score of 55 on PROMIS Depression scale
- AD and AD-MDD subjects:
- Current anxiety disorder (generalized anxiety disorder, panic disorder, agoraphobia and social phobia) assessed by clinician with guidance from the MINI;
- Minimum score of 55 on PROMIS Anxiety Scale
Who cannot join
- All subjects:
- Has uncontrolled, clinically significant neurologic (including seizure disorders): cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, which may impact the ability of the subject to participate or potentially confound the study results;
- Reported body mass index (BMI) > 40;
- History of moderate or severe traumatic brain injury, as assessed by a TBI questionnaire;
- History of eating disorder or obsessive-compulsive disorder, schizophrenia, schizo-affective disorder, bipolar disorder or any sign of psychosis;
- Current post-traumatic stress disorder (PTSD) diagnosis (although history of trauma is allowed);
Show all 20Show fewer
- Current use of medications with major effects on brain function or the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake > 1000 mg/day) following an initial list compiled by LIBR but also assessed on a case-by-case basis. Individuals who are currently on medication (antidepressants such as SSRIs, TCAs, SNRIs, and Bupropion) and who have not undergone dose or medication changes over the past 6 weeks will be allowed to participate;
- Current benzodiazepine or opiate use;
- Moderate to severe current substance use disorder, defined as 5 or more symptoms of the criteria for Substance Use Disorder according to DSM 5;
- Drug or alcohol intoxication (based on positive UTOX or breathalyzer test at screening or study session) or reported alcohol/drug withdrawal, last cannabis use must be >48 hours prior to study session;
- Has a risk of suicide according to the Investigator's clinical judgement or per Columbia-Suicide Severity Rating Scale (C-SSRS) or equivalent PhenX instrument, the subject scores "yes" on items 4 or 5 in the Suicidal Ideation section with referent to a 30-day period prior to Screening/Baseline or the subject has had one or more suicidal attempts with reference to a 2-year period prior to Screening;
- MRI contraindications;
- Is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during this time-period;
- Any subject judged by the Investigator to be inappropriate for the study.
- MDD subjects:
- Current (assessed by clinician with guidance from the MINI) anxiety disorder;
- Score of > 60 on PROMIS Anxiety Scale
- AD subjects:
- Current or past recurrent major depressive episodes assessed by clinician with guidance from the MINI;
- Score of > 60 on PROMIS Depression scale
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
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
Maria A Ironside, DPhil, 617-417-5065, mironside@laureateinstitute.org
Maria Ironside, DPhil
About this study
This mechanistic study uses an anti anxiety drug and brain imaging to study the threat processing system and associated brain circuits in people with depression, anxiety disorders and comorbid depression and anxiety disorders. In a double blind, placebo controlled crossover design, up to 65 individuals will be recruited who will have a diagnosis of major depressive disorder (MDD) and at least one anxiety disorder (AD) (AD-MDD group), up to 65 participants will have a diagnosis of MDD and no diagnosis of an AD and up to 65 participants will have no diagnosis of MDD and a diagnosis of at least one AD will be enrolled to participate in an two session study to obtain 150 completers (50 per group). All participants will receive a single dose of Lorazepam and placebo (order randomized) taken orally. After the ~2.5 hr screening session, participants will complete two identical ~5 hr experimental sessions, each of which include a 30 min eyeblink startle session and a 1.5 hr functional magnetic resonance imaging (MRI) brain scan session. The total time involved in the study is approximately 10.5 hours.
The main questions the study seeks to answer are:
- are people with comorbid depression and anxiety different than those with depression alone in terms of their eyeblink startle response to threat?
- are people with comorbid depression and anxiety different than those with depression alone in terms of their brain activation in response to threat?
- are people with comorbid depression and anxiety different than those with depression alone in terms of their responses to anxiety drugs?
Read the detailed description
This mechanistic study of major depressive disorder (MDD), anxiety disorders (AD) and comorbid anxiety and depression (AD-MDD) aims to break down threat sensitivity into acute threat (AT) and potential threat (PT). A well validated startle task (Neutral, Predictable, Unpredictable or NPU-threat task) and a cutting-edge computational functional magnetic resonance imaging (fMRI) probe of predator escape decisions (Flight Initiation Distance or FID task) will be used to determine whether AD-MDD show increased PT or AT and how the behavioral dynamics of escape decisions are most impaired in AD-MDD. Based on prior studies, we hypothesize that AD is associated with exaggerated PT, whereas MDD is associated with blunted reward/salience responding. Thus, AD-MDD may differ from AD through blunted AT/salience (periaqueductal grey/insula circuitry and Fear-Potentiated Startle [FPS]) and may differ from MDD through increased PT (hippocampal - ventromedial prefrontal cortex (vmPFC) - amygdala dependent circuitry and Anxiety-Potentiated Startle [APS]). To causally probe this circuitry, we will manipulate gamma-aminobutyric acid (GABA) to demonstrate different responses in PT between these three groups, providing further evidence for PT as a targetable process. This mechanistic R01 uses a benzodiazepine within an experimental medicine approach to causally modulate the threat processing system and associated circuits in AD-MDD (N=50), MDD (N=50), and AD (N=50). After the ~2.5 hr screening session, participants will complete two identical ~5 hr experimental sessions, each of which include a 30 min electromyography (EMG) session and a 1.5 hr functional magnetic resonance imaging (fMRI) session. The total time involved in the study is approximately 10.5 hours. In a double-blind placebo crossover design, participants will receive a single 1mg dose of Lorazepam/Placebo and complete threat tasks that delineate PT/AT during startle EMG (NPU task; unpredictable vs predictable shock) and fMRI (FID task; slow vs fast threat).
Specific aims of this project are:
Aim 1: Determine EMG signatures of dysregulated threat processing in AD-MDD.
Hypothesis 1 A (H1A): AD-MDD/AD will exhibit higher PT sensitivity (greater APS) than MDD (NPU APS: AD-MDD > MDD; AD > MDD).
Hypothesis 1 B (H1B): AD-MDD/MDD will exhibit lower AT sensitivity (smaller FPS) than AD (NPU FPS: AD-MDD < AD; MDD < AD).
Aim 2: Determine neural computational signatures of dysregulated threat processing in AD-MDD.
Hypothesis 2 A (H2A): AD-MDD and AD will show higher hippocampal-vmPFC-amygdala responses to FID slow threat (PT) than MDD (FID slow: AD-MDD > MDD; AD > MDD).
Hypothesis 2 B (H2B): AD-MDD and MDD will show lower periaqueductal grey/insula responses to FID fast threat (AT) than AD. (FID fast: AD-MDD < AD; MDD < AD).
Hypothesis 2 C (H2C): Utility functions for the FID task will show both blunted reward and exaggerated threat valuation in AD-MDD, leading to less optimal choices than both MDD and AD.
Aim 3: Determine the relevance of comorbidity to GABAergic manipulation of threat circuitry.
Hypothesis 3 A (H3A): In the NPU task Lorazepam will decrease APS (PT) but not FPS (AT) in AD and AD-MDD but not MDD.
Hypothesis 3 B (H3B): In the FID task Lorazepam will decrease neural response to slow (PT) but not fast (AT) threat and decrease the computational threat valuation parameter in AD and AD-MDD but not MDD.
Significance: These aims seek to mechanistically define and pharmacologically probe process dysfunction and associated targetable circuitry unique to AD-MDD and provide evidence that AD-MDD and MDD should be separated in future clinical trials. This will also inform intervention strategies with circuit-based targets (e.g. for neuromodulation treatments) for AD-MDD, which is a large but under-served treatment resistant group.
- Conditions
- Depression, Anxiety, Fear, Depression, Anxiety and Fear, Anxiety Disorders, Anxious Depression
- Being tested
- Lorazepam, Placebo
- Keywords
- depression, anxiety, fMRI, threat sensitivity, flight initiation distance, startle reflex, benzodiazepine
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorazepamDrug
Also called Lorazepam Intensol, Ativan
1mg of Lorazepam will be prepared by pharmacy (Barnes, Tulsa) in capsule form
PlaceboOther
placebo will be prepared by pharmacy (Barnes, Tulsa) in capsule form
| Study group | Role | What they receive |
|---|---|---|
| Lorazepam | Experimental | Participants will receive a single 1mg dose of Lorazepam, to be taken orally under registered nurse (RN) supervision Receives: Drug: Lorazepam |
| Placebo | Placebo comparator | Participants will receive a single dose of placebo, to be taken orally under RN supervision Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyeblink startle magnitude under threat in AD-MDD compared to MDD.
Difference in magnitude of eyeblink startle response under threat of predictable and unpredictable shock conditions compared to neutral condition in the Neutral, Predictable, Unpredictable (NPU) Threat Task measured with electromyography. Comparing the AD-MDD group to the MDD group.
Measured: 1-2 hours after single session placebo administration, an average of 1-5 weeks after enrollment (placebo could be session 1 or session 2)
Secondary outcomes (2)
Magnitude of blood oxygenated level dependent (BOLD) response to threat in AD-MDD compared to MDD.
Magnitude of hippocampal-vmPFC-amygdala and periaqueductal grey/insula blood oxygenated level dependent (BOLD) responses to fast and slow threat compared to a no threat condition in the Flight Initiation Distance (FID) Task, measured with functional magnetic resonance imaging (fMRI). Comparing the AD-MDD group to the MDD group.
Measured: 1-2 hours after single session placebo administration, an average of 1-5 weeks after enrollment (placebo could be session 1 or session 2)
The effect of Lorazepam on eyeblink startle magnitude and BOLD response to threat in AD-MDD compared to MDD
Comparing the effects of Lorazepam to placebo (within subject) and AD-MDD to MDD (between subject) on the magnitude of eyeblink startle response under threat of predictable and unpredictable shock conditions compared to neutral condition in the NPU Threat Task measured with EMG.
Comparing the effects of Lorazepam to placebo (within subject) and AD-MDD to MDD (between subject) on the magnitude of hippocampal-vmPFC-amygdala and periaqueductal grey/insula blood oxygenated level dependent (BOLD) responses to fast and slow threat compared to a no threat condition in the Flight Initiation Distance Task, measured with fMRI.
Measured: 1-2 hours after single session drug administration, after both Lorazepam and sessions have been completed, an average of 5 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start8 Nov 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double blind crossover design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), California Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Maria Ironside, DPhil, Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004115
- Sponsor's protocol ID
- 2022-009
- Other IDs
- R01MH132565
- Status last verified
- Oct 2025
- First submitted
- 7 Jul 2023
- Last updated
- 31 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression
- ClinicalTrials.gov ID
- NCT06004115
- Acronym / sponsor ID
- 2022-009
- Conditions
- Depression, Anxiety, Fear, Depression, Anxiety and Fear, Anxiety Disorders, Anxious Depression
- Keywords
- depression, anxiety, fMRI, threat sensitivity, flight initiation distance, startle reflex, benzodiazepine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), California Institute of Technology
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 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.
This mechanistic study uses an anti anxiety drug and brain imaging to study the threat processing system and associated brain circuits in people with depression, anxiety disorders and comorbid depression and anxiety disorders. In a double blind, placebo controlled crossover design, up to 65 individuals will be recruited who will have a diagnosis of major depressive disorder (MDD) and at least one anxiety disorder (AD) (AD-MDD group), up to 65 participants will have a diagnosis of MDD and no diagnosis of an AD and up to 65 participants will have no diagnosis of MDD and a diagnosis of at least one AD will be enrolled to participate in an two session study to obtain 150 completers (50 per group). All participants will receive a single dose of Lorazepam and placebo (order randomized) taken orally. After the ~2.5 hr screening session, participants will complete two identical ~5 hr experimental sessions, each of which include a 30 min eyeblink startle session and a 1.5 hr functional magnetic resonance imaging (MRI) brain scan session. The total time involved in the study is approximately 10.5 hours.
The main questions the study seeks to answer are:
- are people with comorbid depression and anxiety different than those with depression alone in terms of their eyeblink startle response to threat?
- are people with comorbid depression and anxiety different than those with depression alone in terms of their brain activation in response to threat?
- are people with comorbid depression and anxiety different than those with depression alone in terms of their responses to anxiety drugs?
Detailed description
This mechanistic study of major depressive disorder (MDD), anxiety disorders (AD) and comorbid anxiety and depression (AD-MDD) aims to break down threat sensitivity into acute threat (AT) and potential threat (PT). A well validated startle task (Neutral, Predictable, Unpredictable or NPU-threat task) and a cutting-edge computational functional magnetic resonance imaging (fMRI) probe of predator escape decisions (Flight Initiation Distance or FID task) will be used to determine whether AD-MDD show increased PT or AT and how the behavioral dynamics of escape decisions are most impaired in AD-MDD. Based on prior studies, we hypothesize that AD is associated with exaggerated PT, whereas MDD is associated with blunted reward/salience responding. Thus, AD-MDD may differ from AD through blunted AT/salience (periaqueductal grey/insula circuitry and Fear-Potentiated Startle [FPS]) and may differ from MDD through increased PT (hippocampal - ventromedial prefrontal cortex (vmPFC) - amygdala dependent circuitry and Anxiety-Potentiated Startle [APS]). To causally probe this circuitry, we will manipulate gamma-aminobutyric acid (GABA) to demonstrate different responses in PT between these three groups, providing further evidence for PT as a targetable process. This mechanistic R01 uses a benzodiazepine within an experimental medicine approach to causally modulate the threat processing system and associated circuits in AD-MDD (N=50), MDD (N=50), and AD (N=50). After the ~2.5 hr screening session, participants will complete two identical ~5 hr experimental sessions, each of which include a 30 min electromyography (EMG) session and a 1.5 hr functional magnetic resonance imaging (fMRI) session. The total time involved in the study is approximately 10.5 hours. In a double-blind placebo crossover design, participants will receive a single 1mg dose of Lorazepam/Placebo and complete threat tasks that delineate PT/AT during startle EMG (NPU task; unpredictable vs predictable shock) and fMRI (FID task; slow vs fast threat).
Specific aims of this project are:
Aim 1: Determine EMG signatures of dysregulated threat processing in AD-MDD.
Hypothesis 1 A (H1A): AD-MDD/AD will exhibit higher PT sensitivity (greater APS) than MDD (NPU APS: AD-MDD > MDD; AD > MDD).
Hypothesis 1 B (H1B): AD-MDD/MDD will exhibit lower AT sensitivity (smaller FPS) than AD (NPU FPS: AD-MDD < AD; MDD < AD).
Aim 2: Determine neural computational signatures of dysregulated threat processing in AD-MDD.
Hypothesis 2 A (H2A): AD-MDD and AD will show higher hippocampal-vmPFC-amygdala responses to FID slow threat (PT) than MDD (FID slow: AD-MDD > MDD; AD > MDD).
Hypothesis 2 B (H2B): AD-MDD and MDD will show lower periaqueductal grey/insula responses to FID fast threat (AT) than AD. (FID fast: AD-MDD < AD; MDD < AD).
Hypothesis 2 C (H2C): Utility functions for the FID task will show both blunted reward and exaggerated threat valuation in AD-MDD, leading to less optimal choices than both MDD and AD.
Aim 3: Determine the relevance of comorbidity to GABAergic manipulation of threat circuitry.
Hypothesis 3 A (H3A): In the NPU task Lorazepam will decrease APS (PT) but not FPS (AT) in AD and AD-MDD but not MDD.
Hypothesis 3 B (H3B): In the FID task Lorazepam will decrease neural response to slow (PT) but not fast (AT) threat and decrease the computational threat valuation parameter in AD and AD-MDD but not MDD.
Significance: These aims seek to mechanistically define and pharmacologically probe process dysfunction and associated targetable circuitry unique to AD-MDD and provide evidence that AD-MDD and MDD should be separated in future clinical trials. This will also inform intervention strategies with circuit-based targets (e.g. for neuromodulation treatments) for AD-MDD, which is a large but under-served treatment resistant group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind crossover design
| Arm | Type | Receives |
|---|---|---|
| Lorazepam | Experimental | Drug: LorazepamParticipants will receive a single 1mg dose of Lorazepam, to be taken orally under registered nurse (RN) supervision |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive a single dose of placebo, to be taken orally under RN supervision |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female or male sex assigned at birth;
- Age 18-65;
- Normal or corrected to normal vision/hearing, as protocol elements may not be valid otherwise;
- Fluent English speaker, capable of providing written informed consent
- Current major depressive episode assessed by clinician with guidance from the MINI;
Key exclusion criteria (20 listed)
- Has uncontrolled, clinically significant neurologic (including seizure disorders): cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, which may impact the ability of the subject to participate or potentially confound the study results;
- Reported body mass index (BMI) > 40;
- History of moderate or severe traumatic brain injury, as assessed by a TBI questionnaire;
- History of eating disorder or obsessive-compulsive disorder, schizophrenia, schizo-affective disorder, bipolar disorder or any sign of psychosis;
- Current post-traumatic stress disorder (PTSD) diagnosis (although history of trauma is allowed);
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 |
|---|---|---|
| LorazepamAlso: Lorazepam Intensol, Ativan1mg of Lorazepam will be prepared by pharmacy (Barnes, Tulsa) in capsule form | Drug | Lorazepam |
| Placeboplacebo will be prepared by pharmacy (Barnes, Tulsa) in capsule form | Other | Placebo |
Primary outcome
Eyeblink startle magnitude under threat in AD-MDD compared to MDD.
Time frame: 1-2 hours after single session placebo administration, an average of 1-5 weeks after enrollment (placebo could be session 1 or session 2)
Difference in magnitude of eyeblink startle response under threat of predictable and unpredictable shock conditions compared to neutral condition in the Neutral, Predictable, Unpredictable (NPU) Threat Task measured with electromyography. Comparing the AD-MDD group to the MDD group.
2 secondary outcomes
Magnitude of blood oxygenated level dependent (BOLD) response to threat in AD-MDD compared to MDD.
Time frame: 1-2 hours after single session placebo administration, an average of 1-5 weeks after enrollment (placebo could be session 1 or session 2)
The effect of Lorazepam on eyeblink startle magnitude and BOLD response to threat in AD-MDD compared to MDD
Time frame: 1-2 hours after single session drug administration, after both Lorazepam and sessions have been completed, an average of 5 weeks after enrollment
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 31 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Maria Ironside, DPhil principal investigator
Laureate Institute for Brain Research
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 Lorazepam in people with Depression, Anxiety and Fear, run by Laureate Institute for Brain Research, Inc. 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 11 inclusion and 20 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 31 Oct 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?
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?
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 Maria Ironside, DPhil (16174175065, mironside@laureateinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eyeblink startle magnitude under threat in AD-MDD compared to MDD. (time frame: 1-2 hours after single session placebo administration, an average of 1-5 weeks after enrollment (placebo could be session 1 or session 2)). 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 31 Oct 2025.