Cognitive Disorders
Conditions
Keywords
Psycho-emotional symptoms
Brief summary
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.
Interventions
DRUGEGb761®
Sponsors
Ipsen
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with increase of total medium FAM test score ≥1 after 3 months treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of total medium FAM test score. | 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. |
| Change from baseline of short-time verbal memory | 3 months | Investigator to assess short-time verbal memory using a set 10-words recall test. |
| Change from baseline of attention | 3 months | Attention assessed using a digit-symbol coding test. The digit symbol score is the percentage of correct symbols completed in 90 seconds. |
| 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 | — |
Countries
Russia
Outcome results
None listed