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Passiflora Extract for Benzodiazepine Withdrawal

NCT ID: NCT03780595

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-27

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Benzodiazepine Withdrawal (Disorder)

Keywords

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Benzodiazepine Withdrawal passiflora

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Passiflora

Group Type EXPERIMENTAL

Passiflora incarnata

Intervention Type DRUG

Passiflora pills administration up to 6 pills per day

Control

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

Control pills administration up to 6 pills per day

Interventions

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Passiflora incarnata

Passiflora pills administration up to 6 pills per day

Intervention Type DRUG

Control

Control pills administration up to 6 pills per day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nutricion Medica S.L.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis Fernando Agüera

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 de Octubre

Locations

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Residencia Albertia Moratalaz

Madrid, , Spain

Site Status RECRUITING

Residencia Amavir Ciudad Lineal

Madrid, , Spain

Site Status RECRUITING

Residencia Nogales Imperial

Madrid, , Spain

Site Status RECRUITING

Residencia Nogales Pontones

Madrid, , Spain

Site Status RECRUITING

Residencia Nogales Puerta de Hierro

Madrid, , Spain

Site Status RECRUITING

Residencia Albertia Valle de la Oliva

Majadahonda, , Spain

Site Status RECRUITING

Residencia Amavir San Agustín

San Agustín del Guadalix, , Spain

Site Status RECRUITING

Residencia Amavir Torrejón

Torrejón de Ardoz, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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María de Andres

Role: CONTACT

Phone: +34 913 14 92 71

Email: [email protected]

Facility Contacts

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Macarena Maroto Algarra, MD

Role: primary

Carmen Figueroa Linki, MD

Role: primary

Silvia Mallón Redondo, MD

Role: primary

Carmela Mañas Martínez, MD

Role: primary

Adriá León García, MD

Role: primary

Liliana González Espinosa, MD

Role: primary

Jorge Luis Cañón, MD

Role: primary

Sara González Blazquez, MD

Role: primary

Other Identifiers

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SEDISTRESS

Identifier Type: -

Identifier Source: org_study_id