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Passiflora Extract for Benzodiazepine Withdrawal (SEDISTRESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780595
Recruitment Status : Unknown
Verified December 2018 by Nutricion Medica S.L..
Recruitment status was:  Recruiting
First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Nutricion Medica S.L.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Benzodiazepine Withdrawal (Disorder) Drug: Passiflora incarnata Drug: Control Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of the Administration of the Passiflora Extract for Benzodiazepine Withdrawal in Institutionalized Older Adults: Clinical Trial Phase III
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Passiflora

Arms and Interventions
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Arm Intervention/treatment
Experimental: Passiflora Drug: Passiflora incarnata
Passiflora pills administration up to 6 pills per day
Placebo Comparator: Control Drug: Control
Control pills administration up to 6 pills per day


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780595


Contacts
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Contact: María de Andres +34 913 14 92 71 mariade.andres@nutricionmedica.com

Locations
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Spain
Residencia Albertia Moratalaz Recruiting
Madrid, Spain
Contact: Macarena Maroto Algarra, MD         
Residencia Amavir Ciudad Lineal Recruiting
Madrid, Spain
Contact: Carmen Figueroa Linki, MD         
Residencia Nogales Imperial Recruiting
Madrid, Spain
Contact: Silvia Mallón Redondo, MD         
Residencia Nogales Pontones Recruiting
Madrid, Spain
Contact: Carmela Mañas Martínez, MD         
Residencia Nogales Puerta de Hierro Recruiting
Madrid, Spain
Contact: Adriá León García, MD         
Residencia Albertia Valle de la Oliva Recruiting
Majadahonda, Spain
Contact: Liliana González Espinosa, MD         
Residencia Amavir San Agustín Recruiting
San Agustín del Guadalix, Spain
Contact: Jorge Luis Cañón, MD         
Residencia Amavir Torrejón Recruiting
Torrejón De Ardoz, Spain
Contact: Sara González Blazquez, MD         
Sub-Investigator: May Ling Carmiña Rodríguez, MD         
Sponsors and Collaborators
Nutricion Medica S.L.
Investigators
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Principal Investigator: Luis Fernando Agüera Hospital Universitario 12 de Octubre
More Information
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Responsible Party: Nutricion Medica S.L.
ClinicalTrials.gov Identifier: NCT03780595    
Other Study ID Numbers: SEDISTRESS
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nutricion Medica S.L.:
Benzodiazepine
Withdrawal
passiflora