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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Cognitive Disorders

Intervention / Treatment
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* Drug: EGb761®


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psycho-emotional symptoms, added to cognitive disorders<br>Patients of middle age and younger with psycho-emotional symptoms, added to cognitive disorders. | Drug: EGb761®<br> <br> * Other names: Tanakan®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with increase of total medium FAM test score ≥1 after 3 months treatment | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of total medium FAM test score. | 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. | 3 months | 
| Change from baseline of short-time verbal memory | Investigator to assess short-time verbal memory using a set 10-words recall test. | 3 months | 
| Change from baseline of attention | Attention assessed using a digit-symbol coding test. The digit symbol score is the percentage of correct symbols completed in 90 seconds. | 3 months | 
| Percentage of patients who answered Completely satisfied, Rather satisfied, Neither satisfied nor dissatisfied, Rather dissatisfied or Completely dissatisfied, when assessing their satisfaction with Tanakan® |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psycho-emotional symptoms