Subclinical Anxious AdultsPhase 4NCT02862236
The Acute Effect of Hypericum Perforatum on Short-Term Memory in Healthy Adults
A Phase 4 study testing Hypericum perforatum extract in people with Subclinical Anxious Adults and Nootropic Potential of Hypericum and Alprazolam, run by Prof. Eldad Yechiam at 1 site in Israel.
Trial summary
Rationale Over-the-counter drugs containing hypericum perforatum (H. perforatum), have been argued to improve memory and sustained attention. So far, these claims have not been supported in human studies. However, previous studies used rather high dosages, and little is known about the acute effect of small dosages. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Subclinical Anxious Adults, Nootropic Potential of Hypericum and Alprazolam, Healthy Adults
- What is being tested?
- Hypericum perforatum extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Feb 2017to 2 Feb 2018
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adults 18 to 40 years old.
Who cannot join
- 1. Demographics: Under 18 years of age or older than 40; pregnant or nursing women; non-fluent Hebrew speakers.
- 2. Body weight: less than 50 kg and more than 90 kg (to ensure effective drug dosage).
- 3. Mental health: Diagnosed with any DSM-V disorder (including ADHD, learning disabilities). These DSM-V disorders may be included in the research: sexual dysfunctions, sleeping disorders and mild-moderate anxiety disorders.
- 4. Any motor disability hampering a participant's ability to perform the experimental task.
- 5. Consumption of any psychoactive substance within the last 72 hours. 6. Ongoing medical problems or use of any substances (e.g., other prescribed medications) which may interact negatively with any of the three drugs used in the experiment.
Trial locations and contacts
1 site in 1 country.
About this study
Rationale Over-the-counter drugs containing hypericum perforatum (H. perforatum), have been argued to improve memory and sustained attention. So far, these claims have not been supported in human studies. However, previous studies used rather high dosages, and little is known about the acute effect of small dosages.
Objective We evaluated whether an acute treatment with Remotiv 500 and Remotiv 250 (500 or 250 mg of H. perforatum quantified to either 1 or 0.5 mg of hypericin) improved memory, sustained attention, as well as mood and state anxiety in healthy adults.
Method A single dosage, randomized, double blind, placebo-controlled trial was conducted with 82 student participants (33 women). Each participant received placebo in one session and one of two dosages in the other session. Order of the sessions and dosage conditions were randomized between subjects. Participants completed a battery of tasks assessing short-term memory capacity and sustained attention.
- Conditions
- Subclinical Anxious Adults, Nootropic Potential of Hypericum and Alprazolam, Healthy Adults
- Being tested
- Hypericum perforatum extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypericum perforatum extractDrug
250 or 500 mg Remotiv capsules of hypericum perforatum extract, p.o.
| Study group | Role | What they receive |
|---|---|---|
| Hypericum perforatum (Remotiv, 250 mg) | Experimental | Not described Receives: Drug: Hypericum perforatum extract |
| Hypericum perforatum (Remotiv, 500 mg) | Experimental | Not described Receives: Drug: Hypericum perforatum extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Go/no-go task
A computerized cognitive task: aimed to measure attention and impulsivity: errors of omission and commission
Measured: one-two hours after drug administration
Digit span task
A computerized cognitive task; accuracy of recalling
Measured: one-two hours after drug administration
Symmetry span task
A computerized cognitive task; accuracy of responses
Measured: one-two hours after drug administration
Operation span task
A computerized cognitive task; accuracy of responses
Measured: one-two hours after drug administration
Groton's Maze task
A computerized task
Measured: one-two hours after drug administration
Secondary outcomes (3)
DASS-21
A self-report questionnaire; scoring of relevant state anxiety items
Measured: one-two hours after drug administration
PANAS
A self-report questionnaire
Measured: one-two hours after drug administration
STAI
A self-report questionnaire; scoring of relevant state anxiety items
Measured: one-two hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start21 Feb 2017
- Primary completion2 Feb 2018
- Study completion2 Feb 2018
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 Subclinical Anxious AdultsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Eldad Yechiam
- Sponsor type
- University, hospital or other
- Collaborators
- Beer Yaakov - Ness Ziona Mental Health Center
- Responsible party
- Sponsor-investigator, Prof. Eldad Yechiam, Technion, Israel Institute of Technology
- Investigators
- Mili Bar-Shaked, MD, Principal investigator, Beer Yaakov - Ness Ziona Mental Health CenterEldad Yechiam, PhD, Study director, Technion, Israel Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862236
- Sponsor's protocol ID
- 10-2016
- Status last verified
- Sep 2018
- First submitted
- 25 Jul 2016
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yechiam E, Ben-Eliezer D, Ashby NJS, Bar-Shaked M. The acute effect of Hypericum perforatum on short-term memory in healthy adults. Psychopharmacology (Berl). 2019 Feb;236(2):613-623. doi: 10.1007/s00213-018-5088-0. Epub 2018 Oct 31.
PubMed 30382352
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Hypericum Perforatum on Short-Term Memory in Healthy Adults
- ClinicalTrials.gov ID
- NCT02862236
- Acronym / sponsor ID
- 10-2016
- Conditions
- Subclinical Anxious Adults, Nootropic Potential of Hypericum and Alprazolam, Healthy Adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Prof. Eldad YechiamUniversity, hospital or other
- Collaborators
- Beer Yaakov - Ness Ziona Mental Health Center
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 10 Aug 2016 (estimated)
- 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.
Rationale Over-the-counter drugs containing hypericum perforatum (H. perforatum), have been argued to improve memory and sustained attention. So far, these claims have not been supported in human studies. However, previous studies used rather high dosages, and little is known about the acute effect of small dosages.
Objective We evaluated whether an acute treatment with Remotiv 500 and Remotiv 250 (500 or 250 mg of H. perforatum quantified to either 1 or 0.5 mg of hypericin) improved memory, sustained attention, as well as mood and state anxiety in healthy adults.
Method A single dosage, randomized, double blind, placebo-controlled trial was conducted with 82 student participants (33 women). Each participant received placebo in one session and one of two dosages in the other session. Order of the sessions and dosage conditions were randomized between subjects. Participants completed a battery of tasks assessing short-term memory capacity and sustained attention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypericum perforatum (Remotiv, 250 mg) | Experimental | Drug: Hypericum perforatum extract |
| Hypericum perforatum (Remotiv, 500 mg) | Experimental | Drug: Hypericum perforatum extract |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy adults 18 to 40 years old.
Key exclusion criteria (5 listed)
- 1. Demographics: Under 18 years of age or older than 40; pregnant or nursing women; non-fluent Hebrew speakers.
- 2. Body weight: less than 50 kg and more than 90 kg (to ensure effective drug dosage).
- 3. Mental health: Diagnosed with any DSM-V disorder (including ADHD, learning disabilities). These DSM-V disorders may be included in the research: sexual dysfunctions, sleeping disorders and mild-moderate anxiety disorders.
- 4. Any motor disability hampering a participant's ability to perform the experimental task.
- 5. Consumption of any psychoactive substance within the last 72 hours. 6. Ongoing medical problems or use of any substances (e.g., other prescribed medications) which may interact negatively with any of the three drugs used in the experiment.
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 |
|---|---|---|
| Hypericum perforatum extract250 or 500 mg Remotiv capsules of hypericum perforatum extract, p.o. | Drug | Hypericum perforatum (Remotiv, 250 mg), Hypericum perforatum (Remotiv, 500 mg) |
Primary outcome
Go/no-go task
Time frame: one-two hours after drug administration
A computerized cognitive task: aimed to measure attention and impulsivity: errors of omission and commission
Digit span task
Time frame: one-two hours after drug administration
A computerized cognitive task; accuracy of recalling
Symmetry span task
Time frame: one-two hours after drug administration
A computerized cognitive task; accuracy of responses
Operation span task
Time frame: one-two hours after drug administration
A computerized cognitive task; accuracy of responses
Groton's Maze task
Time frame: one-two hours after drug administration
A computerized task
3 secondary outcomes
DASS-21
Time frame: one-two hours after drug administration
PANAS
Time frame: one-two hours after drug administration
STAI
Time frame: one-two hours after drug administration
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 14 Sep 2018.
- Derived from this study: PubMed 30382352Yechiam E, Ben-Eliezer D, Ashby NJS, Bar-Shaked M. The acute effect of Hypericum perforatum on short-term memory in healthy adults. Psychopharmacology (Berl). 2019 Feb;236(2):613-623. doi: 10.1007/s00213-018-5088-0. Epub 2018 Oct 31.
- Individual participant dataSharing planned: Undecided
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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.
Mili Bar-Shaked, MD principal investigator
Beer Yaakov - Ness Ziona Mental Health Center
Eldad Yechiam, PhD study director
Technion, Israel Institute of Technology
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 Hypericum perforatum extract in people with Subclinical Anxious Adults and Nootropic Potential of Hypericum and Alprazolam, run by Prof. Eldad Yechiam at 1 site in Israel.
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 1 inclusion and 5 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 14 Sep 2018. 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 Israel. 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 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 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?
Go/no-go task (time frame: one-two hours after drug administration). The study lists 5 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 NCT02862236, 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 14 Sep 2018.