Passiflora Extract for Benzodiazepine Withdrawal (SEDISTRESS)

December 18, 2018 updated by: Nutricion Medica S.L.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Recruiting
        • Residencia Albertia Moratalaz
        • Contact:
          • Macarena Maroto Algarra, MD
      • Madrid, Spain
        • Recruiting
        • Residencia Amavir Ciudad Lineal
        • Contact:
          • Carmen Figueroa Linki, MD
      • Madrid, Spain
        • Recruiting
        • Residencia Nogales Imperial
        • Contact:
          • Silvia Mallón Redondo, MD
      • Madrid, Spain
        • Recruiting
        • Residencia Nogales Pontones
        • Contact:
          • Carmela Mañas Martínez, MD
      • Madrid, Spain
        • Recruiting
        • Residencia Nogales Puerta de Hierro
        • Contact:
          • Adriá León García, MD
      • Majadahonda, Spain
        • Recruiting
        • Residencia Albertia Valle de la Oliva
        • Contact:
          • Liliana González Espinosa, MD
      • San Agustín del Guadalix, Spain
        • Recruiting
        • Residencia Amavir San Agustín
        • Contact:
          • Jorge Luis Cañón, MD
      • Torrejón De Ardoz, Spain
        • Recruiting
        • Residencia Amavir Torrejón
        • Contact:
          • Sara González Blazquez, MD
        • Sub-Investigator:
          • May Ling Carmiña Rodríguez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Drug: Control
Control pills administration up to 6 pills per day
Experimental: Passiflora
Drug: Passiflora incarnata
Passiflora pills administration up to 6 pills per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the percentage of patients who achieve to reduce the dose of benzodiazepines equal or more than 50% Reduction of the benzodiazepine dose
Time Frame: 10 weeks of treatment
10 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutricion Medica S.L.

Investigators

  • Principal Investigator: Luis Fernando Agüera, Hospital Universitario 12 de Octubre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2018

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

December 18, 2018

First Submitted That Met QC Criteria

December 18, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SEDISTRESS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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