Status:
UNKNOWN
Passiflora Extract for Benzodiazepine Withdrawal
Lead Sponsor:
Nutricion Medica S.L.
Conditions:
Benzodiazepine Withdrawal (Disorder)
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
The aim of this clinical trials is compare the percentage of patient who achieve a reduction equal to or greater than 50% in the dose of benzodiazepines at 10 weeks of treatment.
Eligibility Criteria
Inclusion
- Age \> 65 years old
- Stable dose of benzodiazepines during last 3 months ( 4mg loracepam per day or equivalent)
- Capable of giving consent and to answer the questionnaires according to researcher criteria
Exclusion
- Diagnosis of dementia moderate or severe (Test Minimental ≤ 20).
- Acute confusional syndrome at the inclusion
- Panic disorder
- Obsesive-compulsive disorder
- Any type of psycosis or bipolar disorder
- Severe Parkison disease diagnosed
- Current or past diagnosis of epilepsia
- Recent stroke (last month)
- Thyroid disorders not controlled or uncompensated
- Alteration of deglutition
- Previous drugs or alcohol abuse
- Hospitalization (more than 24 hours) during the last month
- Complex priority treatment (dialisis, chemotherapy...)
- Life expectation less than 1 year
- Benzodiazepines therapeutic uses not for anxiety or insomnio
Key Trial Info
Start Date :
September 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT03780595
Start Date
September 27 2018
End Date
December 31 2019
Last Update
December 19 2018
Active Locations (8)
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1
Residencia Albertia Moratalaz
Madrid, Spain
2
Residencia Amavir Ciudad Lineal
Madrid, Spain
3
Residencia Nogales Imperial
Madrid, Spain
4
Residencia Nogales Pontones
Madrid, Spain