Passiflora Extract for Benzodiazepine Withdrawal

Benzodiazepine Withdrawal (Disorder) Clinical Trial

— SEDISTRESS  

Official title:

Efficacy and Safety of the Administration of the Passiflora Extract for Benzodiazepine Withdrawal in Institutionalized Older Adults: Clinical Trial Phase III

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03780595
• Other study ID #: SEDISTRESS
• Status: Recruiting
• Phase: Phase 4
• Start date: September 27, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2018
• Source: Nutricion Medica S.L.
• Contact: María de Andres
• Phone: +34 913 14 92 71
• Email: mariade.andres[@]nutricionmedica.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benzodiazepine Withdrawal (Disorder)

Intervention

Drug:
• Passiflora incarnata
Passiflora pills administration up to 6 pills per day
• Control
Control pills administration up to 6 pills per day

Locations

Country	Name	City	State
Spain	Residencia Albertia Moratalaz	Madrid
Spain	Residencia Amavir Ciudad Lineal	Madrid
Spain	Residencia Nogales Imperial	Madrid
Spain	Residencia Nogales Pontones	Madrid
Spain	Residencia Nogales Puerta de Hierro	Madrid
Spain	Residencia Albertia Valle de la Oliva	Majadahonda
Spain	Residencia Amavir San Agustín	San Agustín del Guadalix
Spain	Residencia Amavir Torrejón	Torrejón De Ardoz

Sponsors (1)

Lead Sponsor	Collaborator
Nutricion Medica S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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