Stress, PsychologicalPhase 2NCT04125810
A Study to Assess the Safety and Efficacy of Probiotic to Modulate Psychological Stress
A Phase 2 study testing Probiotic in people with Stress, Psychological and Healthy, run by Danisco at 7 sites in 2 countries.
Trial summary
The purpose of this clinical trial is to determine whether Probiotic can modulate the psychological stress experienced by healthy medical, dental and health science students preparing for university/institute of technology semester examination (s), measured by self-report scales and hypothalamic pituitary adrenal axis… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Healthy
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 2 Sep 2019to 7 Feb 2020
- Phase
- Phase 2
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary, written, informed consent to participate in the study
- Currently enrolled in medical, dental or health science university/institute of technology course with intention to sit semester examination(s)
- Male or female aged between 18-40 years (inclusive)
- Body mass index (BMI) between 18.5 - 29.9 Kg/m2
- Blood, urine and gastrointestinal safety parameters and blood pressure measurement at baseline indicate they are healthy in the opinion of the Principal Investigator
- In good general health as estimated by the Principal Investigator, based on medical history (self-reported)
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- Ability of the participant (in the Principal Investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
- Ability of the participant (in the Principal Investigator's opinion) to fully comprehend and self-complete all participant reported outcomes (in UK English language)
- Participant is willing to maintain habitual diet (including caffeine and alcohol), physical activity patterns and smoking habits throughout the intervention period
- Agreement to comply with the protocol and study restrictions
- Available for all study visits
- Females of child-bearing potential required to provide a negative urine pregnancy test and be using effective contraception (e.g. surgically sterilized (tubal ligation or hysterectomy or partner is post-vasectomy, with sterility confirmed) or use an intrauterine device (IUD), a diaphragm or condom combined with contraceptive sponge, foam or jelly, or be using an oral contraceptive for at least 2 cycles before the screening visit (Visit 2). Women who are in same sex relationships or abstaining from sex are not required to take a pregnancy test or be using effective contraception
- Male participants must agree to use a condom during sexual intercourse from Visit 3 onwards
- Covered by health insurance system and / or in compliance with the recommendations of National Law in force relating to biomedical research
Who cannot join
- Suspected diagnosis of one or more DSM-IV axis 1 disorder(s), including but not limited to: current major depression, anxiety disorder, bipolar spectrum disorder or schizophrenia, as determined by MINI International Neuropsychiatric Interview (MINI) and/or currently diagnosed with one or more DSM-IV axis 1 disorder(s), per Diagnostic and Statistical Manual of Mental Disorders, 4th Edition.
- Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD)), immunological, metabolic (including diabetes and cardiovascular disease), neurodevelopmental or any condition which contraindicates, in the Principal Investigator's judgement, entry to the study
- Currently taking (from Visit 1 onwards) or have previously taken (last 4 weeks prior to Visit 1) psychoactive medication (anxiolytics, sedatives, hypnotics, anti-psychotics, anti-depressants, anti-convulsants, centrally acting corticosteroids, opioid pain relievers)
- Currently taking (from Visit 1 onwards) medication or dietary supplements that the Principal Investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results (e.g. melatonin, St. John's Wort, Rescue® products including Rescue Remedy®, Rescue® Energy, Rescue® Pastilles, Rescue® Pearls, Rescue Sleep® Rescue PlusTM, omega-3 dietary supplements (including fish oil), Cannabidiol (CBD), non-steroidal anti-inflammatory drugs (NSAIDS), over-the-counter sleep medication (not categorized as sedatives, hypnotics or anti-depressants), anti-coagulants, anti-cholinergic drugs or acetylcholinesterase inhibitors, proton pump inhibitors, anti-histamines that cause drowsiness, pseudoephedrine)
- Recent (within last 4 weeks prior to Visit 1) or ongoing antibiotic therapy
- Currently taking (from Visit 1 onwards) concentrated sources of probiotics and/or prebiotics other than the provided study products (e.g., probiotic/prebiotic tablets, capsules, drops or powders), including yoghurt / yoghurt drinks
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- Pregnant or lactating female, or pregnancy planned during the intervention period
- Have self-reported dyslexia
- History of or current alcohol, drug, or medication abuse (self-reported)
- Self-declared illicit drug users (including cannabis and cocaine) in the past 1 month prior to Visit 1
- Excessive alcohol consumption (consuming > 8 units of alcohol for men and > 6 units of alcohol for women in a single session) > 3 times per week for 3 weeks prior to Visit 1
- Significant change in tobacco, snuff, nicotine or e-cigarette usage habits in the past 1 month before Visit 1 or planned cessation of the use of these products during the intervention period
- Contraindication to any substance in the investigational product
- Participation in another study with any investigational product or drug within 60 days of Visit 1
- Principal Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study
- Participant under administrative or legal supervision
- Previous participation in the ChillEx study
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United Kingdom6 sites
MediNova Warwickshire Dedicated Research Centre
Kenilworth
MediNova North London Dedicated Research Centre
Northwood
MediNova Research East London Clinical Studies Centre
Romford
MediNova Yorkshire Dedicated Research Centre
Shipley
MediNova South London Dedicated Research Centre, Queen Mary's Hospital
Sidcup
MediNova West London Dedicated Research Centre
Wokingham
About this study
Official title: A Randomized, Triple-blind, Placebo-controlled, Parallel-groups Clinical Trial to Assess the Safety and Efficacy of Lactobacillus Paracasei (Lpc-37) to Modulate Psychological Stress
The purpose of this clinical trial is to determine whether Probiotic can modulate the psychological stress experienced by healthy medical, dental and health science students preparing for university/institute of technology semester examination (s), measured by self-report scales and hypothalamic pituitary adrenal axis activity, compared with placebo.
Read the detailed description
The purpose of this clinical trial is to determine whether Probiotic can modulate the psychological stress experienced by healthy medical, dental and health science students preparing for university/institute of technology semester examination (s), measured by self-report scales and hypothalamic pituitary adrenal axis activity, compared with placebo.
The target group of the proposed study will consist of stress vulnerable / sensitive, healthy male and female adult participants currently enrolled in medical, dental or health science university course that are experiencing psychological stress induced by preparation for university/institute of technology semester examination (s).
- Conditions
- Stress, Psychological, Healthy
- Being tested
- Probiotic, Placebo
- Keywords
- Probiotic, Stress, Gut-brain axis
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticBiological
Probiotic
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Probiotic Receives: Biological: Probiotic |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Trait Anxiety Inventory (STAI)-state total score
Absolute change in STAI-state total score between the active versus placebo group
Measured: from baseline to 8 weeks
Secondary outcomes (20)
Change in Cortisol awakening response (CAR)
The absolute changes in the CAR will be analyzed in the same fashion as described for the primary variable.
Measured: from baseline to 8 weeks
Change in perceived stress (Visual Analog Scale (VAS)-stress)
The absolute change in VAS-stress score will be analyzed in the same fashion as described for the primary variable.
- Visual Analog Scale (VAS)-stress.
- Participants indicate on a 100mm line how stressed they perceived themselves to be over the last week. The scale is anchored from 0 = felt not stressed at all to 100 = felt highly stressed. Scores are determined by measuring from the left end to the mark using a ruler.
Measured: from baseline to 8 weeks
Change in DASS-21, depression scale score from baseline (Visit 3) to 8 weeks (Visit 5)
The absolute changes in DASS-21, depression scale score will be analyzed in the same fashion as described for the primary variable.
- Depression, anxiety, stress scale (21 items).
- The DASS gives information about negative emotional states of depression, anxiety and stress. The questionnaire includes 3 scales (depression, anxiety and stress) of which each scale includes 7 items that are divided into subscales of 2-5 items of similar content.
Measured: from baseline to 8 weeks
Change in DASS-21, anxiety scale score from baseline (Visit 3) to 8 weeks (Visit 5)
The absolute changes in DASS-21, anxiety scale score will be analyzed in the same fashion as described for the primary variable.
- Depression, anxiety, stress scale (21 items).
- The DASS gives information about negative emotional states of depression, anxiety and stress. The questionnaire includes 3 scales (depression, anxiety and stress) of which each scale includes 7 items that are divided into subscales of 2-5 items of similar content.
Measured: from baseline to 8 weeks
Change in DASS-21, stress scale score from baseline (Visit 3) to 8 weeks (Visit 5)
The absolute changes in DASS-21, stress scale score will be analyzed in the same fashion as described for the primary variable.
- Depression, anxiety, stress scale (21 items).
- The DASS gives information about negative emotional states of depression, anxiety and stress. The questionnaire includes 3 scales (depression, anxiety and stress) of which each scale includes 7 items that are divided into subscales of 2-5 items of similar content.
Measured: from baseline to 8 weeks
Change in HADS, depression score from baseline (Visit 3) to 8 weeks (Visit 5)
The absolute changes in HADS, depression score will be analyzed in the same fashion as described for the primary variable.
- Hospital anxiety and depression scale.
- The HADS is a 14 item self-report screening tool which is widely used in the clinic to assess levels of depression and anxiety.
Measured: from baseline to 8 weeks
Change in HADS, anxiety score from baseline (Visit 3) to 8 weeks (Visit 5)
The absolute changes in HADS, anxiety score will be analyzed in the same fashion as described for the primary variable.
- Hospital anxiety and depression scale.
- The HADS is a 14 item self-report screening tool which is widely used in the clinic to assess levels of depression and anxiety.
Measured: from baseline to 8 weeks
Change in PSS, total score from baseline (Visit 3) to 8 weeks (Visit 5)
The absolute changes in PSS, total score will be analyzed in the same fashion as described for the primary variable.
- Cohen's perceived stress scale.
- The PSS is a self-report measure in which participants rate, on a 5-point scale ranging from 0 (never) to 4 (very often), how often they have particular thoughts or feelings described by each of the 10 items.
- Scores range from 0-40, with higher scores indicating greater stress over the previous month.
Measured: from baseline to 8 weeks
Change in BL-VAS, alertness score from baseline (Visit 3) to 8 weeks (Visit 5)
The absolute changes in BL-VAS, alertness score will be analyzed in the same fashion as described for the primary variable.
- Bond-Lader visual analogue scale.
- The Bond-Lader VAS consist of 16 scales with anchors of related mood/ arousal dimensions (e.g. calm-excited; strong-feeble).
- Participants indicate on a 100mm line how they feel along each mood dimension at that specific time, and scores from the 16 scales are converted into three composite mood/ arousal dimensions; alertness, calmness and contentedness.
Measured: from baseline to 8 weeks
Change in BL-VAS, contentment score
The absolute changes in BL-VAS, contentment score will be analyzed in the same fashion as described for the primary variable.
Measured: from baseline to 8 weeks
Change in BL-VAS, calmness score
The absolute changes in BL-VAS, calmness score will be analyzed in the same fashion as described for the primary variable.
Measured: from baseline to 8 weeks
Change in Pittsburgh Sleep Quality Index (PSQI), total score
The absolute changes in the PSQI, total score will be analyzed in the same fashion as described for the primary variable.
Measured: from baseline to 8 weeks
Change in PSQI, duration of sleep score
The absolute changes in the PSQI, duration of sleep score will be analyzed in the same fashion as described for the primary variable.
Measured: from baseline to 8 weeks
Change in PSQI, sleep disturbance score
The absolute changes in the PSQI, sleep disturbance score will be analyzed in the same fashion as described for the primary variable.
Measured: from baseline to 8 weeks
Change in PSQI, sleep latency score
The absolute changes in the PSQI, sleep latency score will be analyzed in the same fashion as described for the primary variable.
Measured: from baseline to 8 weeks
Change in PSQI, daytime dysfunction due to sleepiness score
The absolute changes in the PSQI, daytime dysfunction due to sleepiness score will be analyzed in the same fashion as described for the primary variable.
Measured: from baseline to 8 weeks
Change in PSQI, sleep efficiency score
The absolute changes in the PSQI, sleep efficiency score will be analyzed in the same fashion as described for the primary variable.
Measured: from baseline to 8 weeks
Change in PSQI, subjective sleep quality score
The absolute changes in the PSQI, subjective sleep quality score will be analyzed in the same fashion as described for the primary variable.
Measured: from baseline to 8 weeks
Change in PSQI, use of medication sleep score
The absolute changes in the PSQI, use of medication sleep score will be analyzed in the same fashion as described for the primary variable.
Measured: from baseline to 8 weeks
Change in evening cortisol
Evening cortisol: Participants will provide x1 saliva sample each evening during two consecutive working days at approximately 8pm prior to Visit 3, Visit 4, Visit 5 and Visit 6.
Concentrations of cortisol will be assayed in saliva supernatants using ELISA kits specifically designed for cortisol quantification, following manufacturer's instructions.
Measured: from baseline 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 posted14 Oct 2019
- Study start2 Sep 2019
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
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 Stress, PsychologicalStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc, Daacro, 4Pharma Ltd.
- Responsible party
- Sponsor
- Investigators
- Balgit Chhokar, Study director, Medinova East London Dedicated Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125810
- Sponsor's protocol ID
- NH03821
- Status last verified
- Mar 2020
- First submitted
- 30 Aug 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Makela SM, Griffin SM, Reimari J, Evans KC, Hibberd AA, Yeung N, Ibarra A, Junnila J, Turunen J, Beboso R, Chhokar B, Dinan TG, Cryan J, Patterson E. Efficacy and safety of Lacticaseibacillus paracasei Lpc-37(R) in students facing examination stress: A randomized, triple-blind, placebo-controlled clinical trial (the ChillEx study). Brain Behav Immun Health. 2023 Aug 1;32:100673. doi: 10.1016/j.bbih.2023.100673. eCollection 2023 Oct.
PubMed 37662485
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-blind, Placebo-controlled, Parallel-groups Clinical Trial to Assess the Safety and Efficacy of Lactobacillus Paracasei (Lpc-37) to Modulate Psychological Stress
- ClinicalTrials.gov ID
- NCT04125810
- Acronym / sponsor ID
- NH03821
- Conditions
- Stress, Psychological, Healthy
- Keywords
- Probiotic, Stress, Gut-brain axis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc, Daacro, 4Pharma Ltd.
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 14 Oct 2019 (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 clinical trial is to determine whether Probiotic can modulate the psychological stress experienced by healthy medical, dental and health science students preparing for university/institute of technology semester examination (s), measured by self-report scales and hypothalamic pituitary adrenal axis activity, compared with placebo.
Detailed description
The purpose of this clinical trial is to determine whether Probiotic can modulate the psychological stress experienced by healthy medical, dental and health science students preparing for university/institute of technology semester examination (s), measured by self-report scales and hypothalamic pituitary adrenal axis activity, compared with placebo.
The target group of the proposed study will consist of stress vulnerable / sensitive, healthy male and female adult participants currently enrolled in medical, dental or health science university course that are experiencing psychological stress induced by preparation for university/institute of technology semester examination (s).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Biological: ProbioticProbiotic |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Voluntary, written, informed consent to participate in the study
- Currently enrolled in medical, dental or health science university/institute of technology course with intention to sit semester examination(s)
- Male or female aged between 18-40 years (inclusive)
- Body mass index (BMI) between 18.5 - 29.9 Kg/m2
- Blood, urine and gastrointestinal safety parameters and blood pressure measurement at baseline indicate they are healthy in the opinion of the Principal Investigator
Key exclusion criteria (17 listed)
- Suspected diagnosis of one or more DSM-IV axis 1 disorder(s), including but not limited to: current major depression, anxiety disorder, bipolar spectrum disorder or schizophrenia, as determined by MINI International Neuropsychiatric Interview (MINI) and/or currently diagnosed with one or more DSM-IV axis 1 disorder(s), per Diagnostic and Statistical Manual of Mental Disorders, 4th Edition.
- Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD)), immunological, metabolic (including diabetes and cardiovascular disease), neurodevelopmental or any condition which contraindicates, in the Principal Investigator's judgement, entry to the study
- Currently taking (from Visit 1 onwards) or have previously taken (last 4 weeks prior to Visit 1) psychoactive medication (anxiolytics, sedatives, hypnotics, anti-psychotics, anti-depressants, anti-convulsants, centrally acting corticosteroids, opioid pain relievers)
- Currently taking (from Visit 1 onwards) medication or dietary supplements that the Principal Investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results (e.g. melatonin, St. John's Wort, Rescue® products including Rescue Remedy®, Rescue® Energy, Rescue® Pastilles, Rescue® Pearls, Rescue Sleep® Rescue PlusTM, omega-3 dietary supplements (including fish oil), Cannabidiol (CBD), non-steroidal anti-inflammatory drugs (NSAIDS), over-the-counter sleep medication (not categorized as sedatives, hypnotics or anti-depressants), anti-coagulants, anti-cholinergic drugs or acetylcholinesterase inhibitors, proton pump inhibitors, anti-histamines that cause drowsiness, pseudoephedrine)
- Recent (within last 4 weeks prior to Visit 1) or ongoing antibiotic therapy
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 |
|---|---|---|
| ProbioticProbiotic | Biological | Probiotic |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
State Trait Anxiety Inventory (STAI)-state total score
Time frame: from baseline to 8 weeks
Absolute change in STAI-state total score between the active versus placebo group
20 secondary outcomes
Change in Cortisol awakening response (CAR)
Time frame: from baseline to 8 weeks
Change in perceived stress (Visual Analog Scale (VAS)-stress)
Time frame: from baseline to 8 weeks
Change in DASS-21, depression scale score from baseline (Visit 3) to 8 weeks (Visit 5)
Time frame: from baseline to 8 weeks
Change in DASS-21, anxiety scale score from baseline (Visit 3) to 8 weeks (Visit 5)
Time frame: from baseline to 8 weeks
Change in DASS-21, stress scale score from baseline (Visit 3) to 8 weeks (Visit 5)
Time frame: from baseline to 8 weeks
Change in HADS, depression score from baseline (Visit 3) to 8 weeks (Visit 5)
Time frame: from baseline to 8 weeks
Change in HADS, anxiety score from baseline (Visit 3) to 8 weeks (Visit 5)
Time frame: from baseline to 8 weeks
Change in PSS, total score from baseline (Visit 3) to 8 weeks (Visit 5)
Time frame: from baseline to 8 weeks
Change in BL-VAS, alertness score from baseline (Visit 3) to 8 weeks (Visit 5)
Time frame: from baseline to 8 weeks
Change in BL-VAS, contentment score
Time frame: from baseline to 8 weeks
Change in BL-VAS, calmness score
Time frame: from baseline to 8 weeks
Change in Pittsburgh Sleep Quality Index (PSQI), total score
Time frame: from baseline to 8 weeks
Change in PSQI, duration of sleep score
Time frame: from baseline to 8 weeks
Change in PSQI, sleep disturbance score
Time frame: from baseline to 8 weeks
Change in PSQI, sleep latency score
Time frame: from baseline to 8 weeks
Change in PSQI, daytime dysfunction due to sleepiness score
Time frame: from baseline to 8 weeks
Change in PSQI, sleep efficiency score
Time frame: from baseline to 8 weeks
Change in PSQI, subjective sleep quality score
Time frame: from baseline to 8 weeks
Change in PSQI, use of medication sleep score
Time frame: from baseline to 8 weeks
Change in evening cortisol
Time frame: from baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 37662485Makela SM, Griffin SM, Reimari J, Evans KC, Hibberd AA, Yeung N, Ibarra A, Junnila J, Turunen J, Beboso R, Chhokar B, Dinan TG, Cryan J, Patterson E. Efficacy and safety of Lacticaseibacillus paracasei Lpc-37(R) in students facing examination stress: A randomized, triple-blind, placebo-controlled clinical trial (the ChillEx study). Brain Behav Immun Health. 2023 Aug 1;32:100673. doi: 10.1016/j.bbih.2023.100673. eCollection 2023 Oct.
- 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. This study is not recruiting at the moment.
Balgit Chhokar study director
Medinova East London Dedicated Research Center
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Stress, Psychological and Healthy, run by Danisco at 7 sites in 2 countries.
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 14 inclusion and 17 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 25 Mar 2020. 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 United Kingdom, Ireland. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
State Trait Anxiety Inventory (STAI)-state total score (time frame: from baseline to 8 weeks). 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 NCT04125810, 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 25 Mar 2020.