Mild Cognitive Impairment, Lewy Body Dementia, Parkinson's Disease Rapid Eye Movement Sleep Behavior Disorder, Parkinson's Disease DementiaPhase 2CLIN-011NCT04739423

A Study of Clenbuterol (CST-103) Co-administered With Nadolol (CST-107) in Subjects With Neurodegenerative Disorders

A Phase 2 study of Mild Cognitive Impairment, Lewy Body Dementia, Parkinson's Disease Rapid Eye Movement Sleep Behavior Disorder, Parkinson's Disease Dementia, run by CuraSen Therapeutics, Inc. at 7 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a Phase II, randomized, placebo-controlled, double-blind, crossover study on the CNS and pharmacodynamic effects of clenbuterol (CST-103) co-administered with nadolol (CST-107) in 4 subject populations with Neurodegenerative Disorders. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Mild Cognitive Impairment, Lewy Body Dementia, Parkinson's Disease Rapid Eye Movement Sleep Behavior Disorder, Parkinson's Disease Dementia
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 7 sitesin 3 countries
Study dates: 28 Jun 2021to 31 Aug 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with PD:
Male or female subjects ≥ 40 and ≤ 80 years of age, at time of informed consent.
Diagnosed with Parkinson's Disease, as defined by the United Kingdom Parkinson Disease Brain Bank criteria, associated with REM sleep behavior disorder (PD)
Modified Hoehn \& Yahr ≥ stage 1 and ≤ stage 3 during "On" period as documented in the 3 months prior to Screening or completed at Screening.
Montreal Cognitive Assessment (MoCA) score ≥ 18 and ≤ 28.
Subjects with MCI:

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Male or female subjects ≥ 50 and ≤ 80 years of age, at time of informed consent.
Meet the criteria for amnestic Mild Cognitive Impairment (MCI) as per the National Institute on Aging-Alzheimer's Association core clinical criteria.
Montreal Cognitive Assessment (MoCA) score ≥ 18 and ≤ 26.
No dementia according to the International Classifications of Diseases (ICD)-10 and Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV.
Memory complaint reported by the subject or his/her partner, family member or caregiver.
Score of greater than or equal to one standard deviation below age and educational norms in the Digit Symbol Substitution Test (DSST) during Screening.
Cognitive decline not primarily caused by vascular, traumatic, or medical problems.
Subjects with Dementia with Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD):
Male or female subjects ≥ 50 and ≤ 80 years of age, at time of informed consent.
Diagnosis of dementia associated with Dementia with Lewy Bodies or Parkinson's disease (PDD).
Documented cognitive fluctuations endorsed on the Dementia Cognitive Fluctuation Scale (DCFS) with a combined score of ≥8 in items 4, 11, 12 and 14.
Montreal Cognitive Assessment (MoCA) score ≥ 18 and ≤ 26.
Have informant or caregiver throughout the study who will submit written consent to cooperate with this study, who routinely accompanies and/or stays with subject 12 hours or more a week, assists with treatment compliance, provides assessments and is able to escort the subject on required visits to study institution.
Modified Hoehn \& Yahr ≥ stage 1 and ≤ stage 3 during "On" period as documented in the 3 months prior to Screening or completed at Screening.
Stable concomitant medical and/or psychiatric illnesses in the judgement of the PI.
For ALL Subjects:
Unless confirmed to be azoospermic (vasectomized or secondary to medical cause), males must agree to use a male condom from Day 1 throughout the study when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant.
Females of childbearing potential (i.e., not postmenopausal or surgically sterile) who have a male partner must have a negative serum pregnancy test result and must agree to one of the following from start of Screening through 30 days after the last study medication administration: use a reliable method of birth control, or monogamous relationship with a male partner of confirmed sterility, or practice complete abstinence.
Females of non-childbearing potential may be enrolled if it is documented that they are postmenopausal.
Body weight greater or equal to 50 kg and body mass index (BMI) between 18 and 35 kg/m2, inclusive at Screening.
Stable medical conditions for 3 months prior to Screening visit (e.g., controlled hypertension, dyslipidemia).
Willing to follow the protocol requirements and comply with protocol restrictions.
Capable of providing informed consent and complying with study procedures. Subjects who are unable to provide consent may use a Legally Authorized Representative.

Who cannot join

Poorly controlled hypertension despite lifestyle modifications and/or pharmacotherapy.
Pulmonary disease, including asthma if requiring the use of a β2-Adrenergic bronchodilator, or evidence of clinically significant moderate or severe pulmonary symptoms.
Clinical signs indicating syndromes such as corticobasal degeneration, supranuclear gaze palsy, multiple system atrophy, chronic traumatic encephalopathy, signs of frontal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement, or Babinski sign.
Current evidence or history in past two years of epilepsy, focal brain lesion, head injury with loss of consciousness or meeting DSM-IV diagnostic criteria for psychotic disorders.
Evidence of any significant clinical disorder or laboratory finding (or in the case of potassium levels below normal range) that renders the participant unsuitable for receiving an investigational drug.
History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).

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Any clinically significant illness or disease as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory assessments conducted at Screening.
Clinically significant abnormalities of ECG, including QTcF > 450 ms, for males and QTcF > 470 ms for females, and/or HR < 50 beats per minute, or evidence of clinically significant bundle branch blocks, as indicated by 12-lead ECG.
Calculated creatinine clearance of ≤70 mL/min according to the Cockcroft-Gault equation.
Current use of any prohibited prescription medication (high-dose aspirin, paracetamol or levodopa, β-AR agonists or β-AR blockers, hypnotics or benzodiazepines other than clonazepam, monoamine oxidase inhibitors, opioids ), over-the-counter medication, or herbal supplements/products.
Prior treatment with any investigational drug ≤90 days prior to dosing (Day 1), or ≤5 half-lives of the drug (whichever is longer), or current enrollment in any other study treatment or disease study, except for observational studies.
Known or suspected alcohol or substance abuse within the past 12 months and/or positive test for alcohol or drugs of abuse.
Active suicidal ideation within 3 months prior to study Screening.
Positive screening test for hepatitis C antibody (HCV Ab) or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] at Screening).
Positive screening test for human immunodeficiency virus (HIV).
Current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Contraindications to wearing the BioStamp digital device sensors, which include but are not limited to implanted pacemakers, defibrillators, or other active implantable devices.
Known allergies or hypersensitivities to adhesives or hydrogel.
Other reasons for which the PI considers it is not in the best interest of the participant to undertake the study.

Trial locations and contacts

7 sites in 3 countries.

Country

City, postcode or hospital

7 sites in 3 countries

Australia3 sites

Wesley Medical Research Ltd
Brisbane, Queensland, QLD 4066
Royal Melbourne Hospital
Melbourne, Victoria, 3050
The University of Sydney
Sydney, New South Wales, 2006

Other trials in Australia

United Kingdom3 sites

MAC
Blackpool, Lancashire, FY2 0JH
MAC
Manchester, M13 9NQ
MAC
Tankersley, Barnsley, S75 3DL

Other trials in United Kingdom

New Zealand1 site

NZBRI
Christchurch, 8011

Other trials in New Zealand

About this study

Official title: A Phase II, Randomized, Placebo-Controlled, Double-Blind, Crossover, Study of the Pharmacodynamic Effects of CST-103 Co-administered With CST-107 on the Central Nervous System in Subjects With Neurodegenerative Disorders

Read the detailed description

Approximately 40 subjects with Parkinson's Disease (PD) with REM Sleep Behavior Disorder (RBD) and Depressive Symptoms, Mild Cognitive Impairment (MCI) with Depressive Symptoms, Dementia with Lewy Bodies (DLB) with Cognitive Fluctuations, and Parkinson's Disease Dementia (PDD) with Cognitive Fluctuations were to be enrolled in a 2 period, 2-way crossover design following study eligibility confirmation during the screening period. The number of subjects enrolled in each cohort could change as emerging data are reviewed from this and other studies.

During each treatment period, subjects received daily doses of clenbuterol (CST-103) co-administered with nadolol (CST-107) or matching placebo for 14 days. Each treatment period was separated by a washout period of 14 days (+5-day window).

All subjects completed clinical and pharmacodynamic assessments during each treatment period and PK blood samples were collected prior to, during and after study medication administration.

Conditions: Mild Cognitive Impairment, Lewy Body Dementia, Parkinson's Disease Rapid Eye Movement Sleep Behavior Disorder, Parkinson's Disease Dementia
Being tested: clenbuterol (CST-103), nadolol (CST-107), matching placebo
Medical subject headings: Cognitive Dysfunction, Lewy Body Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

clenbuterol (CST-103), nadolol (CST-107), matching placeboDrug
clenbuterol (CST-103) and matching placebo orange capsules; nadolol (CST-107) and matching placebo white capsules

Study groups in NCT04739423
Study group	Role	What they receive
CST-103/CST-107 to Placebo	Experimental	Subjects will receive daily doses of CST-103 co-administered with CST-107 for 14 days, followed by a washout period of no drug for 14 days, followed by matching placebo for CST-103 and matching placebo for CST-107 for 14 days. Receives: Drug: clenbuterol (CST-103), nadolol (CST-107), matching placebo
Placebo to CST-103/CST-107	Experimental	Subjects will receive daily doses of matching placebo for CST-103 co-administered with matching placebo for CST-107 for 14 days, followed by a washout period of no drug for 14 days, followed by daily doses of CST-103 co-administered with CST-107 for 14 days. Receives: Drug: clenbuterol (CST-103), nadolol (CST-107), matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT)
Faces with six different basic emotions (happiness, fear, anger, disgust, sadness, surprise) are briefly displayed on a screen and participants are required to indicate the expression of the face via a button-press. Cohort A only.
Measured: Days 7 and 14 of each Treatment Period (Two 14-day periods)
Change From Baseline in Cognitive Fluctuations
Dementia Cognitive Fluctuation Scale (DCFS). Number of participants with improvement relative to screening. Cohort B only.
Measured: Screening, Days 1 and 14 of each Treatment Period (Two 14-day periods)

Secondary outcomes (4)

Change From Baseline in CANTAB Cognitive Assessments
The CANTAB cognitive assessments consists of a series of interrelated computerized tests of memory, attention, and executive function, administered via a touch sensitive screen. This includes the immediate and delayed Verbal Recognition Memory (VRM) recall and recognition tests that measure the ability to encode and subsequently retrieve verbal information.
Measured: Days 1, 7, 14 of each Treatment Period (Two 14-day periods)
Digital Wearable Device (BioStamp) - Sleeping Heart Rate
A wireless device that measures physical activity and sleep while at home.
Measured: Screening, Days 1-14 of each Treatment Period (Two 14-day periods)
Digital Wearable Device (BioStamp) - Sleeping Heart Rate Variability (HRV)
A wireless device that measures physical activity and sleep while at home.
Measured: Screening, Days 1-14 of each Treatment Period (Two 14-day periods)
Digital Wearable Device (BioStamp) - Sleeping Heart Rate Variability (HRV) - Root Mean Square of Successive Differences (RMSSD)
A wireless device that measures physical activity and sleep while at home.
Measured: Screening, Days 1-14 of each Treatment Period (Two 14-day periods)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 202131 Aug 2022

First posted4 Feb 2021
Study start28 Jun 2021
Primary completion4 Jul 2022
Study completion31 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mild Cognitive Impairment, Lewy Body Dementia, Parkinson's Disease Rapid Eye Movement Sleep Behavior Disorder, Parkinson's Disease DementiaStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Two 14-day periods, 2-way crossover design
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04739423
Sponsor's protocol ID: CST103/CST107-CLIN-011
Acronym: CLIN-011
Status last verified: Oct 2024
First submitted: 29 Jan 2021
Last updated: 2 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
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 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Placebo-Controlled, Double-Blind, Crossover, Study of the Pharmacodynamic Effects of CST-103 Co-administered With CST-107 on the Central Nervous System in Subjects With Neurodegenerative Disorders
ClinicalTrials.gov ID: NCT04739423
Acronym / sponsor ID: CLIN-011 / CST103/CST107-CLIN-011
Conditions: Mild Cognitive Impairment, Lewy Body Dementia, Parkinson's Disease Rapid Eye Movement Sleep Behavior Disorder, Parkinson's Disease Dementia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: CuraSen Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 28 Jun 2021 (actual)
Primary completion: 4 Jul 2022 (actual)
Study completion: 31 Aug 2022 (actual)
First posted: 4 Feb 2021 (actual)
Results: Posted 2 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

All subjects completed clinical and pharmacodynamic assessments during each treatment period and PK blood samples were collected prior to, during and after study medication administration.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Two 14-day periods, 2-way crossover design

Arm	Type	Receives
CST-103/CST-107 to Placebo	Experimental	Drug: clenbuterol (CST-103), nadolol (CST-107), matching placeboSubjects will receive daily doses of CST-103 co-administered with CST-107 for 14 days, followed by a washout period of no drug for 14 days, followed by matching placebo for CST-103 and matching placebo for CST-107 for 14 days.
Placebo to CST-103/CST-107	Experimental	Drug: clenbuterol (CST-103), nadolol (CST-107), matching placeboSubjects will receive daily doses of matching placebo for CST-103 co-administered with matching placebo for CST-107 for 14 days, followed by a washout period of no drug for 14 days, followed by daily doses of CST-103 co-administered with CST-107 for 14 days.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (29 listed)

Male or female subjects ≥ 40 and ≤ 80 years of age, at time of informed consent.
Diagnosed with Parkinson's Disease, as defined by the United Kingdom Parkinson Disease Brain Bank criteria, associated with REM sleep behavior disorder (PD)
Modified Hoehn \& Yahr ≥ stage 1 and ≤ stage 3 during "On" period as documented in the 3 months prior to Screening or completed at Screening.
Montreal Cognitive Assessment (MoCA) score ≥ 18 and ≤ 28.
Male or female subjects ≥ 50 and ≤ 80 years of age, at time of informed consent.

Key exclusion criteria (19 listed)

Poorly controlled hypertension despite lifestyle modifications and/or pharmacotherapy.
Pulmonary disease, including asthma if requiring the use of a β2-Adrenergic bronchodilator, or evidence of clinically significant moderate or severe pulmonary symptoms.
Clinical signs indicating syndromes such as corticobasal degeneration, supranuclear gaze palsy, multiple system atrophy, chronic traumatic encephalopathy, signs of frontal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement, or Babinski sign.
Current evidence or history in past two years of epilepsy, focal brain lesion, head injury with loss of consciousness or meeting DSM-IV diagnostic criteria for psychotic disorders.
Evidence of any significant clinical disorder or laboratory finding (or in the case of potassium levels below normal range) that renders the participant unsuitable for receiving an investigational drug.

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
clenbuterol (CST-103), nadolol (CST-107), matching placeboclenbuterol (CST-103) and matching placebo orange capsules; nadolol (CST-107) and matching placebo white capsules	Drug	CST-103/CST-107 to Placebo, Placebo to CST-103/CST-107

Primary outcome

Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT)
Time frame: Days 7 and 14 of each Treatment Period (Two 14-day periods)
Faces with six different basic emotions (happiness, fear, anger, disgust, sadness, surprise) are briefly displayed on a screen and participants are required to indicate the expression of the face via a button-press. Cohort A only.
Change From Baseline in Cognitive Fluctuations
Time frame: Screening, Days 1 and 14 of each Treatment Period (Two 14-day periods)
Dementia Cognitive Fluctuation Scale (DCFS). Number of participants with improvement relative to screening. Cohort B only.

4 secondary outcomes

Change From Baseline in CANTAB Cognitive Assessments
Time frame: Days 1, 7, 14 of each Treatment Period (Two 14-day periods)
Digital Wearable Device (BioStamp) - Sleeping Heart Rate
Time frame: Screening, Days 1-14 of each Treatment Period (Two 14-day periods)
Digital Wearable Device (BioStamp) - Sleeping Heart Rate Variability (HRV)
Time frame: Screening, Days 1-14 of each Treatment Period (Two 14-day periods)
Digital Wearable Device (BioStamp) - Sleeping Heart Rate Variability (HRV) - Root Mean Square of Successive Differences (RMSSD)
Time frame: Screening, Days 1-14 of each Treatment Period (Two 14-day periods)

Results and safety

Results posted to the registry on 2 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PD Sequence 1	12	12
PD Sequence 2	13	12
MCI Sequence 1	6	5
MCI Sequence 2	7	7
PDD or DLB Sequence 1	1	0
PDD or DLB Sequence 2	2	1

Primary outcome: Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT)

Time frame: Days 7 and 14 of each Treatment Period (Two 14-day periods). Least squares mean (Standard Error). Unit: Percent change

Measure	PD - Placebo n = 23	PD - Active n = 24	MCI - Placebo n = 12	MCI - Active n = 12
Accuracy for happiness - Change from baseline to Day 14	8.1316 (2.5783)	13.6138 (2.5462)	8.0168 (4.9441)	6.7407 (4.9441)
Accuracy for sadness - Change from baseline to Day 14	-6.9002 (1.7950)	-2.1048 (1.7749)	-7.7744 (2.3576)	-5.8789 (2.3576)
Reaction time for anger - Change from baseline to Day 7	-150.77 (78.70)	16.52 (75.97)	-17.51 (158.55)	-25.03 (165.47)

PD - Placebo vs PD - Active: Least Squares Mean: 5.4822 (95% CI 0.0575 to 10.9069), p = 0.0479, Mixed Models Analysis
PD - Placebo vs PD - Active: Least Squares Mean: 4.7954 (95% CI 0.9843 to 8.6064), p = 0.0161, Mixed Models Analysis
PD - Placebo vs PD - Active: Least Squares Mean: 167.29 (95% CI 25.36 to 309.23), p = 0.0237, Mixed Models Analysis

Population analysed: Full Analysis Set (FAS) - The FAS included all randomized study subjects who had taken at least one dose of blinded study drug in this crossover study. In accordance with the protocol this outcome measure was only applicable for Cohort A. Data are presented by treatment for each patient population analyzed.

Primary outcome: Change From Baseline in Cognitive Fluctuations

Time frame: Screening, Days 1 and 14 of each Treatment Period (Two 14-day periods). Count of participants. Unit: Participants

Measure	PDD or DLB Placebo n = 3	PDD + DLB - Active n = 2
How great is the difference between the worst and the best period of function on that day?	2	2
Length of time sleeping during day.	2	1
How often is patient drowsy and lethargic during the day?	1	1
Overall, how would you rate the patient's level of consciousness on a usual day?	2	2

Population analysed: All participants enrolled in Cohort B.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose to end of study visit (approximately 8 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PD - Placebo	0 of 25 (0%)	16 of 25 (64%)	0 of 25
PD - Active	1 of 24 (4.2%)	20 of 24 (83.3%)	0 of 24
MCI - Placebo	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
MCI - Active	0 of 13 (0%)	7 of 13 (53.8%)	0 of 13
PDD and DLB - Placebo	1 of 3 (33.3%)	2 of 3 (66.7%)	0 of 3
PDD and DLB - Active	0 of 2 (0%)	2 of 2 (100%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Chief Medical Officer study director

CuraSen Therapeutics, Inc.

7 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 29 inclusion and 19 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: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Australia, United Kingdom, New Zealand. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) (time frame: Days 7 and 14 of each Treatment Period (Two 14-day periods)). The study lists 2 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 NCT04739423.

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 2 Dec 2024.