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

Overview

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.

Full Title of Study: “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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2015

Interventions

  • Drug: EGb761®

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of patients with increase of total medium FAM test score ≥1 after 3 months treatment
    • Time Frame: 3 months
    • 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.

Secondary Measures

  • Change from baseline of total medium FAM test score.
    • Time Frame: 3 months
    • 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.
  • Change from baseline of short-time verbal memory
    • Time Frame: 3 months
    • Investigator to assess short-time verbal memory using a set 10-words recall test.
  • Change from baseline of attention
    • Time Frame: 3 months
    • Attention assessed using a digit-symbol coding test. The digit symbol score is the percentage of correct symbols completed in 90 seconds.
  • Percentage of patients who answered “Completely satisfied”, “Rather satisfied”, “Neither satisfied nor dissatisfied”, “Rather dissatisfied” or “Completely dissatisfied”, when assessing their satisfaction with Tanakan®
    • Time Frame: 3 months

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ipsen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ipsen Medical Director, Study Director, Ipsen

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