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Completed

NCT Number: NCT02321475

EGb 761® (Tanakan®) Effectiveness in the Treatment of Patients of Middle Age and Younger With Psycho-emotional Symptoms, Added to Cognitive Disorders

The purpose of this study is to determine the effectiveness of EGb 761® (Tanakan®) in Russian patients of middle age and younger, suffering from psycho-emotional symptoms added to cognitive disorders based on the improvement of FAM test (feeling-healthy, activity, mood test) score.

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Key information

Conditions

Cognitive Disorders Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Moscow State Medical University, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who signed the Informed Consent for participation in the observational study before collection of any information
  • Patients who complain of psycho-emotional disturbance (of any intensity)
  • Men and women aged 18-45 years, who prescribed to receive Tanakan® for cognitive disorders

Exclusion criteria

  • Presence of any contraindications listed in the Tanakan® local SmPC (hypersensitivity to any of the components of Tanakan®, pregnancy, lactation, erosive gastritis in acute phase, gastric ulcer and duodenum ulcer in acute phase, acute cerebrovascular accident, acute myocardial infarction, congenital galactosemia, lactase deficiency, glucose-galactose malabsorption, haemolysis)
  • Presence of dementia (according to Diagnostic and Statistical Manual of Mental Disorders [DSM IV])
  • Disturbance of usual activities of daily living (e.g. self-care)
  • Patients taking antipsychotic drugs, antidepressants, tranquillisers and nootropic agents
  • Presence of any severe disease or condition which could affect cognitive function (e.g. Parkinson disease, epilepsy, brain inflammatory disease, major depression, recent post-stroke condition, recent brain-trauma etc.);
  • Presence of anxiety or depression according to the Hospital Anxiety and Depression Scale (11 points and more).

Treatment and study plan

EGb761®

Drug

Other names: Tanakan®

Primary outcomes

  1. Percentage of patients with increase of total medium FAM test score ≥1 after 3 months treatment

    Time frame: 3 months

    The FAM test is a questionnaire using three subscales (i.e. General health, Activity, and Mood). Scores for each subscale range from 3 to -3 (where -3 is bad and 3 is good). The total for each subscale and arithmetical mean is calculated.

Secondary outcomes

  1. Change from baseline of total medium FAM test score.

    Time frame: 3 months

    The FAM test is a questionnaire using three subscales (i.e. General health, Activity, and Mood). Scores for each subscale range from 3 to -3 (where -3 is bad and 3 is good). The total for each subscale and arithmetical mean is calculated.

  2. Change from baseline of short-time verbal memory

    Time frame: 3 months

    Investigator to assess short-time verbal memory using a set 10-words recall test.

  3. Change from baseline of attention

    Time frame: 3 months

    Attention assessed using a digit-symbol coding test. The digit symbol score is the percentage of correct symbols completed in 90 seconds.

  4. Percentage of patients who answered "Completely satisfied", "Rather satisfied", "Neither satisfied nor dissatisfied", "Rather dissatisfied" or "Completely dissatisfied", when assessing their satisfaction with Tanakan®

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Non-interventional Prospective Observational Study to Describe EGB 761® (Tanakan®) Effectiveness in the Treatment of Patients of Middle Age and Younger With Psycho-emotional Symptoms, Added to Cognitive Disorders.

Acronym: TAYPES

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 22, 2014
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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