Clinical trial NCT02321475: EGb 761® (Tanakan®) Effectiveness in the Treatment of Patients of Middle Age and Younger With Psycho-emotional Symptoms, Added to Cognitive Disorders
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Disorders
Keywords: Psycho-emotional symptoms
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2014-12-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Middle-age or younger patients with cognitive disorders and psycho-emotional symptoms (principal diagnosis).

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of patients with increase of total medium FAM test score ≥1 after 3 months treatment
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline of total medium FAM test score.
timeFrame: 3 months
measure: Change from baseline of short-time verbal memory
timeFrame: 3 months
measure: Change from baseline of attention
timeFrame: 3 months
measure: Percentage of patients who answered "Completely satisfied", "Rather satisfied", "Neither satisfied nor dissatisfied", "Rather dissatisfied" or "Completely dissatisfied", when assessing their satisfaction with Tanakan®
timeFrame: 3 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russian National Research Medical University
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: