- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02321475
EGb 761® (Tanakan®) Effectiveness in the Treatment of Patients of Middle Age and Younger With Psycho-emotional Symptoms, Added to Cognitive Disorders (TAYPES)
March 30, 2020 updated by: Ipsen
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
Study Type
Observational
Enrollment (Actual)
54
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Moscow, Russian Federation, 119435
- First Moscow State Medical University
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Moscow, Russian Federation, 117152
- Russian National Research Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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.
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Other Names:
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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
Time Frame: 3 months
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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.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
Change from baseline of short-time verbal memory
Time Frame: 3 months
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Investigator to assess short-time verbal memory using a set 10-words recall test.
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3 months
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Change from baseline of attention
Time Frame: 3 months
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Attention assessed using a digit-symbol coding test.
The digit symbol score is the percentage of correct symbols completed in 90 seconds.
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3 months
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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
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-38-00240-138
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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