Passiflora Extract for Benzodiazepine Withdrawal (SEDISTRESS)

Nutricion Medica

Status and phase: Unknown; Phase 4

Conditions: Benzodiazepine Withdrawal (Disorder)

Treatments: Drug: Control; Drug: Passiflora incarnata

Study type: Interventional

Funder types: Industry

Identifiers

NCT03780595

SEDISTRESS

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups, including a placebo group

Passiflora

Experimental group

Treatment:

Drug: Passiflora incarnata

Control

Placebo Comparator group

Treatment:

Drug: Control