Passiflora Extract for Benzodiazepine Withdrawal
SEDISTRESS
Efficacy and Safety of the Administration of the Passiflora Extract for Benzodiazepine Withdrawal in Institutionalized Older Adults: Clinical Trial Phase III
1 other identifier
interventional
108
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2018
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 27, 2018
CompletedFirst Submitted
Initial submission to the registry
December 18, 2018
CompletedFirst Posted
Study publicly available on registry
December 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedDecember 19, 2018
December 1, 2018
9 months
December 18, 2018
December 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
10 weeks of treatment
Study Arms (2)
Passiflora
EXPERIMENTALControl
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age \> 65 years old
- Stable dose of benzodiazepines during last 3 months ( 4mg loracepam per day or equivalent)
- Capable of giving consent and to answer the questionnaires according to researcher criteria
You may not qualify if:
- Diagnosis of dementia moderate or severe (Test Minimental ≤ 20).
- Panic disorder
- Obsesive-compulsive disorder
- Any type of psycosis or bipolar disorder
- Severe Parkison disease diagnosed
- Current or past diagnosis of epilepsia
- Recent stroke (last month)
- Thyroid disorders not controlled or uncompensated
- Alteration of deglutition
- Previous drugs or alcohol abuse
- Hospitalization (more than 24 hours) during the last month
- Complex priority treatment (dialisis, chemotherapy...)
- Life expectation less than 1 year
- Benzodiazepines therapeutic uses not for anxiety or insomnio
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
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, Spain
Study Officials
- PRINCIPAL INVESTIGATOR
Luis Fernando Agüera
Hospital Universitario 12 de Octubre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2018
First Posted
December 19, 2018
Study Start
September 27, 2018
Primary Completion
June 30, 2019
Study Completion
December 31, 2019
Last Updated
December 19, 2018
Record last verified: 2018-12