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

Cognitive Disorders Clinical Trial

— TAYPES  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321475
• Other study ID #: A-38-00240-138
• Status: Completed
• Start date: June 2014
• Est. completion date: April 2015

Study information

• Verified date: March 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Disorders

Intervention

Drug:
• EGb761®

Locations

Country	Name	City	State
Russian Federation	First Moscow State Medical University	Moscow
Russian Federation	Russian National Research Medical University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change from baseline of short-time verbal memory	Investigator to assess short-time verbal memory using a set 10-words recall test.	3 months
Secondary	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
Secondary	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