Passiflora Extract for Benzodiazepine Withdrawal

Phase 4

• Conditions: Benzodiazepine Withdrawal (Disorder)
• Interventions: Drug: Passiflora incarnata; Drug: Control

• Registration Number: NCT03780595
• Lead Sponsor: Nutricion Medica S.L.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-27
• Status Verified: 2018-12
• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-18
• Last Update Submitted: 2018-12-18
• Study First Posted: 2018-12-19
• Last Update Posted: 2018-12-19
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Passiflora	Passiflora incarnata	-
Control	Control	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Residencia Albertia Moratalaz; 🇪🇸 Madrid, Spain

Residencia Nogales Imperial; 🇪🇸 Madrid, Spain

Residencia Nogales Pontones; 🇪🇸 Madrid, Spain

Residencia Amavir Ciudad Lineal; 🇪🇸 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, Spain

Residencia Nogales Puerta de Hierro; 🇪🇸 Madrid, Spain