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BDNFBDNFmNCT04955457

BDNF Promoter Methylation: Effects on Cognition, Stress and Anxiety and Depression Symptom in Healthy Women.

An observational study of BDNF and Memory Impairment, run by Ana Flávia Marçal Pessoa at 1 site in Brazil.

Completed

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

Official record
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Trial summary

The purpose of this study is to explore the association between BDNF methylation and neurocognitive performance, perceived stress, and well-being in healthy women. Read more about this study

Who is it for?
Ages 23 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
BDNF, Memory Impairment, Stress
What is being tested?
Healthy women active teachers
How many people
100 participants
Where
1 siteBrazil
Study dates
1 Sep 2018to 1 Jun 2019
Phase
Observational
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 23 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Female participants will be recruited from public schools linked to the "Diretoria Regional de Educação de Santo Amaro - DRESA" - a southern section of the São Paulo City Hall public education secretaryship.

Who may be able to join

None listed.

Who cannot join

  • diagnosis of depression
  • diagnosis of anxiety disorder
  • diagnosis of squizofrenia
  • report of an infectious condition in the last 15 days before collecting a blood sample;

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Universidade Federal de Sao Paulo

    São Paulo, WI, 53703

Other trials in Brazil

About this study

The purpose of this study is to explore the association between BDNF methylation and neurocognitive performance, perceived stress, and well-being in healthy women.

Being tested
Healthy women active teachers
Keywords
BDNF methylation, Memory, women, Stress
Medical subject headings
Memory Disorders

What participants receive

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

  • Healthy women active teachersOther

    The neuropsychological testing data, psychometric measure, demographic, clinical and lifestyle information and blood samples were collected at similar time points. This group not received any intervention.

What is being measured

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

  1. Explore BDNF methylation level in healthy women active teachers

    Venous blood was obtained from all participants to DNA extraction and BDNF methylation analyses.

    Measured: baseline

  2. Explore episodic memory in healthy women active teachers

    The RAVLT is a validated neuropsychologic test to evaluate learning and memory (episodic memory)an assessment of verbal learning over 5 trials and 30-minute delayed free recall

    Measured: Baseline

  3. Explore working memory in healthy women active teachers

    Investigates the capacity of working memory (auditory) and attention. It consists of two tables with different numbers, one with a direct order and another with a reverse order. The sequence of numbers is read aloud to the participant, one by one, where he must immediately repeat them to the examiner. The same happens with numbers in reverse order, but the participant must repeat the numbers backwards (reverse order). The maximum possible score to be reached in the forward order is 16 points, and in the reverse order 14 points totaling 30 points in the total score. For evaluation, the result must be compared with the standardization according to age.

    Measured: Baseline

  4. Explore attention in healthy women active teachers

    Trail Making Test (TMT): is used to assess divided attention, consisting of two parts (A and B). It also assesses motor function, mental flexibility, visual processing speed and aspects of sustained and alternating attention. In both parts, the participant must draw a path marked by numbers in the shortest time possible and without taking the pencil off the paper. In part A, you must draw a path marked by numbers in ascending order, from 1 to 25. Part B has a higher degree of difficulty, requiring greater cognitive demand from the participant, who must draw the path, now marked with numbers ranging from 1 to 13, alternating with letters, ranging from A to L, thus: 1-A-2-B-3-C... And so on. The score is measured by the total time the participant took to perform each task and compared with the standardization for their age group.

    Measured: Baseline

  5. Explore selective attention in healthy women active teachers

    • Stroop Test: Allows you to detect neurological and brain problems and is also used to check and measure levels of concentration and cognitive functions, selective attention and speed of processing information. The test must be applied to adults over 25 years of age and consists of three tasks: the first in reading words, the second in naming colors, and the third in identifying and naming the color of each word that is written in distinct colors from its nomenclature, which is called the interference effect (or stroop effect). The score is obtained by scoring total correct answers in each of these tasks, and compared with the current standardization.

    Measured: Baseline

  6. Explore perceived stress in healthy women active teachers

    Perceived Stress Scale (PSS): is used to assess the individual's perception of stress (subjective stress assessment), where it should be noted how uncontrollable and unpredictable the events of their life experienced in the last month seem to be. The test consists of 10 items, 6 of positive aspects and 4 of negative aspects, and must be answered within a Likert-type frequency scale (ranging from 0 - Never to 4-Always). For its evaluation, all the answers must be added together to obtain a total perceived stress score, which must be compared with the standardization of the test for the equivalent population

    Measured: Baseline

  7. Explore resilience in healthy women active teachers

    • Connor-Davidson Resilience Scale (CD-RISC): a 25-item scale divided into 5 factors, namely: personal competence, confidence in one's instincts, positive acceptance of change, tolerance in the face of adversity, control and spirituality. The scale is self-applicable and the participant must mark answers ranging from 0 (never true) to 4 (always true). The result is obtained through the sum of the total score, which can range from 0 to 40 points, where the higher the score, the greater the participant's degree of resilience.

    Measured: Baseline

  8. Explore psychological well-being in healthy women active teachers

    • Psychological Well-Being Scale (PWBS): the scale consists of 84 items, subdivided into 6 scales that assess the dimensions of psychological well-being, with 14 items each. The answers are obtained through a Likert-type scale, ranging from 0 (totally disagree) to 6 (totally agree). The subscales are divided as follows: Self-acceptance, Positive relationship with others, autonomy, mastery of the environment, purpose in life and personal growth. The result is obtained through the sum of the items of each subscale, and the higher the score, the better the levels of psychological well-being according to each subscale.

    Measured: Baseline

  9. Explore positive and negative affect in healthy women active teachers

    • Positive and negative affect scale (PANAS): Aims to identify the dimensions of affect of subjective well-being, through 20 items provided, where participants must indicate how they have been feeling lately. These items are distributed into 10 of subjective emotions that comprise negative affects, and 10 items that comprise positive affects, being issued on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely).

    Measured: Baseline

  10. Explore anxiety and depression symptoms in healthy women active teachers

    • Hospital Anxiety and Depression Scale (HADS): It was developed to identify probable and possible levels and cases of Anxiety and Depression in clinical and non-clinical populations. It consists of 14 items divided into two subscales of 7 items each, where one comprises questions to identify signs of anxiety disorders, and the other of depression. The answers range from 0 to 3 points, ranging from absent to very frequent, with a maximum score of 21 points. The cutoff point obtained in the literature for both subscales is ≥ 9 points

    Measured: Baseline

Timeline

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

  1. First posted8 Jul 2021
  2. Study start1 Sep 2018
  3. Primary completion1 Jun 2019
  4. Study completion1 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04955457
Sponsor's protocol ID
3.159.669/2018
Acronym
BDNFm
Status last verified
Jul 2021
First submitted
21 Jun 2021
Last updated
13 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of BDNF and Memory Impairment, run by Ana Flávia Marçal Pessoa at 1 site in Brazil.

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 0 inclusion and 4 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 13 Jul 2021. 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 Brazil. 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.

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?

Explore BDNF methylation level in healthy women active teachers (time frame: baseline). The study lists 10 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 NCT04955457.

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 13 Jul 2021.

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