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

NCT02321475 | Completed

• 1 other identifier: A-38-00240-138
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Cognitive Disorders

Keywords

Psycho-emotional symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline of total medium FAM test score.

  3 months

• Change from baseline of short-time verbal memory

  3 months

• Change from baseline of attention

  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

Study Arms (1)

Psycho-emotional symptoms, added to cognitive disorders

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

Drug: EGb761®

Interventions

EGb761® DRUG

Also known as: Tanakan®

Psycho-emotional symptoms, added to cognitive disorders

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ipsen: lead

Study Sites (2)

Russian National Research Medical University

Moscow, 117152, Russia

Location

First Moscow State Medical University

Moscow, 119435, Russia

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Ginkgo biloba extract

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 22, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

RU (2)