EGb 761® (Tanakan®) Effectiveness in the Treatment of Patients of Middle Age and Younger With Psycho-emotional Symptoms, Added to Cognitive Disorders
- Conditions
- Cognitive Disorders
- Interventions
- Drug: EGb761®
- Registration Number
- NCT02321475
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Psycho-emotional symptoms, added to cognitive disorders EGb761® Patients of middle age and younger with psycho-emotional symptoms, added to cognitive disorders.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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.
Trial Locations
- Locations (2)
Russian National Research Medical University
🇷🇺Moscow, Russian Federation
First Moscow State Medical University
🇷🇺Moscow, Russian Federation