Benzodiazepine Withdrawal (Disorder)
Conditions
Keywords
Benzodiazepine, Withdrawal, passiflora
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.
Interventions
Passiflora pills administration up to 6 pills per day
DRUGControl
Control pills administration up to 6 pills per day
Sponsors
Nutricion Medica S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the percentage of patients who achieve to reduce the dose of benzodiazepines equal or more than 50% Reduction of the benzodiazepine dose | 10 weeks of treatment |
Countries
Spain
Contacts
Primary ContactMaría de Andres
Outcome results
None listed