ADMINISTRATION OF THE PASSIFLORA EXTRACT FOR BENZODIAZEPINE WITHDRAWAL IN INSTITUTIONALIZED OLDER ADULTS
- Conditions
- benzodiazepines withdrawnMedDRA version: 20.1 Level: LLT Classification code 10004477 Term: Benzodiazepine dependent System Organ Class: 100000004873MedDRA version: 20.0 Level: LLT Classification code 10048013 Term: Withdrawn System Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2017-004514-25-ES
- Lead Sponsor
- utrición Medica S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 108
1. Age > 65 years old
2. Stable dose of benzodiazepines during last 3 months ( 4mg loracepam per day or equivalent)
3. Capable of giving consent and to answer the questionnaires according to researcher criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 108
1. Diagnosis of dementia moderate or severe (Test Minimental = 20).
2. Acute confusional syndrome at the inclusion
3- Panic disorder
4. Obsesive-compulsive disorder
5. Any type of psycosis or bipolar disorder
6. Severe Parkison disease diagnosed
7. Current or past diagnosis of epilepsia
8. Recent stroke (last month)
9. Thyroid disorders not controlled or uncompensated
10. Alteration of deglutition
11. Previous drugs or alcohol abuse
12. Hospitalization (more than 24 hours) during the last month
13. Complex priority treatment (dialisis, chemotherapy...)
14. Life expectation less than 1 year
15. Benzodiazepines therapeutic uses not for anxiety or insomnio
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method