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The Acute Effect of Hypericum Perforatum on Short-Term Memory in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02862236
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
Beer Yaakov – Ness Ziona Mental Health Center
Information provided by (Responsible Party):
Prof. Eldad Yechiam, Technion, Israel Institute of Technology

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Subclinical Anxious Adults Nootropic Potential of Hypericum and Alprazolam Healthy Adults Drug: Hypericum perforatum extract Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Acute Effect of Hypericum Perforatum on Short-Term Memory in Healthy Adults
Actual Study Start Date : February 21, 2017
Actual Primary Completion Date : February 2, 2018
Actual Study Completion Date : February 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Hypericum perforatum (Remotiv, 250 mg) Drug: Hypericum perforatum extract
250 or 500 mg Remotiv capsules of hypericum perforatum extract, p.o.

Experimental: Hypericum perforatum (Remotiv, 500 mg) Drug: Hypericum perforatum extract
250 or 500 mg Remotiv capsules of hypericum perforatum extract, p.o.




Primary Outcome Measures :
  1. 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

  2. Digit span task [ Time Frame: one-two hours after drug administration ]
    A computerized cognitive task; accuracy of recalling

  3. Symmetry span task [ Time Frame: one-two hours after drug administration ]
    A computerized cognitive task; accuracy of responses

  4. Operation span task [ Time Frame: one-two hours after drug administration ]
    A computerized cognitive task; accuracy of responses

  5. Groton's Maze task [ Time Frame: one-two hours after drug administration ]
    A computerized task


Secondary Outcome Measures :
  1. DASS-21 [ Time Frame: one-two hours after drug administration ]
    A self-report questionnaire; scoring of relevant state anxiety items

  2. PANAS [ Time Frame: one-two hours after drug administration ]
    A self-report questionnaire

  3. STAI [ Time Frame: one-two hours after drug administration ]
    A self-report questionnaire; scoring of relevant state anxiety items



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adults 18 to 40 years old.

Exclusion Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862236


Locations
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Israel
Technion, Israel Institute of Technology
Haifa, Israel
Sponsors and Collaborators
Prof. Eldad Yechiam
Beer Yaakov – Ness Ziona Mental Health Center
Investigators
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Principal Investigator: Mili Bar-Shaked, MD Beer Yaakov – Ness Ziona Mental Health Center
Study Director: Eldad Yechiam, PhD Technion, Israel Institute of Technology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Eldad Yechiam, Associate Professor, Behavioral Science, Technion, Israel Institute of Technology
ClinicalTrials.gov Identifier: NCT02862236    
Other Study ID Numbers: 10-2016
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No