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

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.

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Disorders
• Intervention / Treatment: Drug: EGb761®

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119435
    • First Moscow State Medical University
  • Moscow, Russian Federation, 117152
    • Russian National Research Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Middle-age or younger patients with cognitive disorders and psycho-emotional symptoms (principal diagnosis).

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Psycho-emotional symptoms, added to cognitive disorders; Patients of middle age and younger with psycho-emotional symptoms, added to cognitive disorders.	Drug: EGb761®; Other Names: Tanakan®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change from baseline of short-time verbal memory	Investigator to assess short-time verbal memory using a set 10-words recall test.	3 months
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
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

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 22, 2014

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Psycho-emotional symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders
• Other Study ID Numbers: A-38-00240-138