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

Ipsen

Status: Completed

Conditions: Cognitive Disorders

Treatments: Drug: EGb761®

Study type: Observational

Funder types: Industry

Identifiers

NCT02321475

A-38-00240-138

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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).

Trial design

54 participants in 1 patient group

Psycho-emotional symptoms, added to cognitive disorders

Description:

Patients of middle age and younger with psycho-emotional symptoms, added to cognitive disorders.

Treatment:

Drug: EGb761®