ADMINISTRATION OF THE PASSIFLORA EXTRACT FOR BENZODIAZEPINE WITHDRAWAL IN INSTITUTIONALIZED OLDER ADULTS

EFFICACY AND SAFETY OF THE ADMINISTRATION OF THE PASSIFLORA EXTRACT FOR BENZODIAZEPINE WITHDRAWAL IN INSTITUTIONALIZED OLDER ADULTS : CLINICAL TRIAL PHASE III. - SEDISTRESS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004514-25-ES

Enrollment

108

Registered

2018-06-20

Start date

2018-08-17

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

benzodiazepines withdrawn MedDRA version: 20.1 Level: LLT Classification code 10004477 Term: Benzodiazepine dependent System Organ Class: 100000004873 MedDRA version: 20.0 Level: LLT Classification code 10048013 Term: Withdrawn System Organ Class: 100000004873

Interventions

Trade Name: Sedistress Product Name: Sedistress Pharmaceutical Form: Tablet INN or Proposed INN: Passiflora CAS Number: 8000041-61-4

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

Exclusion 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
Main Objective: To compare the percentage of patients who achieve to reduce the dose of benzodiazepines equal or more than 50% after 10 weeks of treatment;Primary end point(s): Dose of benzodiazepines; Secondary Objective: ? To compare the anxiety according to Hamilton Scale between both group after 5,10 weeks and 6 months of treatment ? To analyse the quality of life according to Euroqol 5D between both group after 5,10 weeks and 6 months of treatment ? To evaluate the cognitive state according to minimental test between both group after 5,10 weeks and 6 months of treatment ? To compare the sleep quality according to Pittsburgh questionnaire between both group after 5,10 weeks and 6 months of treatment ? To evaluate the funtional state according to Barthel Index between both group after 10 weeks and 6 months of treatment ? To compare the number of falls between both groups ? To analyse the side effect detected between both groups ;Timepoint(s) of evaluation of this end point: After 10 weeks of treatment	—

Measure

Time frame

Main Objective: To compare the percentage of patients who achieve to reduce the dose of benzodiazepines equal or more than 50% after 10 weeks of treatment;Primary end point(s): Dose of benzodiazepines; Secondary Objective: ? To compare the anxiety according to Hamilton Scale between both group after 5,10 weeks and 6 months of treatment ? To analyse the quality of life according to Euroqol 5D between both group after 5,10 weeks and 6 months of treatment ? To evaluate the cognitive state according to minimental test between both group after 5,10 weeks and 6 months of treatment ? To compare the sleep quality according to Pittsburgh questionnaire between both group after 5,10 weeks and 6 months of treatment ? To evaluate the funtional state according to Barthel Index between both group after 10 weeks and 6 months of treatment ? To compare the number of falls between both groups ? To analyse the side effect detected between both groups ;Timepoint(s) of evaluation of this end point: After 10 weeks of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Hamilton Rating Scale for Depression Euroqol-5D (EQ-5D) Mini-Mental State Examination Falls Pittsburg questionnaire Barthel index Adverse events ;Timepoint(s) of evaluation of this end point: 5 and 10 weeks and 6 months after the begining of the treatment	—

Countries

Spain

Contacts

Public ContactMarisa Marquez

Nutrición Medica S.L.

marisa.marquez@nutricion.medica.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026