Benzodiazepine Withdrawal (Disorder)Phase 4SEDISTRESSNCT03780595
Passiflora Extract for Benzodiazepine Withdrawal
A Phase 4 study testing Passiflora incarnata in people with Benzodiazepine Withdrawal (Disorder), run by Nutricion Medica S.L. at 8 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Benzodiazepine Withdrawal (Disorder)
- What is being tested?
- Passiflora incarnata
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 8 sitesSpain
- Study dates
- 27 Sep 2018to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of dementia moderate or severe (Test Minimental ≤ 20).
- Acute confusional syndrome at the inclusion
- Panic disorder
- Obsesive-compulsive disorder
- Any type of psycosis or bipolar disorder
- Severe Parkison disease diagnosed
Show all 15Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites, 8 recruiting
- Recruiting
Residencia Albertia Moratalaz
Madrid
Macarena Maroto Algarra, MD
- Recruiting
Residencia Amavir Ciudad Lineal
Madrid
Carmen Figueroa Linki, MD
- Recruiting
Residencia Nogales Imperial
Madrid
Silvia Mallón Redondo, MD
- Recruiting
Residencia Nogales Pontones
Madrid
Carmela Mañas Martínez, MD
- Recruiting
Residencia Nogales Puerta de Hierro
Madrid
Adriá León García, MD
- Recruiting
Residencia Albertia Valle de la Oliva
Majadahonda
Liliana González Espinosa, MD
- Recruiting
Residencia Amavir San Agustín
San Agustín del Guadalix
Jorge Luis Cañón, MD
- Recruiting
Residencia Amavir Torrejón
Torrejón de Ardoz
Sara González Blazquez, MD
May Ling Carmiña Rodríguez, MD
About this study
Official title: 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.
- Conditions
- Benzodiazepine Withdrawal (Disorder)
- Being tested
- Passiflora incarnata, Control
- Keywords
- Benzodiazepine, Withdrawal, passiflora
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passiflora incarnataDrug
Passiflora pills administration up to 6 pills per day
ControlDrug
Control pills administration up to 6 pills per day
| Study group | Role | What they receive |
|---|---|---|
| Passiflora | Experimental | Not described Receives: Drug: Passiflora incarnata |
| Control | Placebo comparator | Not described Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the percentage of patients who achieve to reduce the dose of benzodiazepines equal or more than 50% Reduction of the benzodiazepine dose
Measured: 10 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start27 Sep 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benzodiazepine Withdrawal (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricion Medica S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis Fernando Agüera, Principal investigator, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780595
- Sponsor's protocol ID
- SEDISTRESS
- Acronym
- SEDISTRESS
- Status last verified
- Dec 2018
- First submitted
- 18 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Administration of the Passiflora Extract for Benzodiazepine Withdrawal in Institutionalized Older Adults: Clinical Trial Phase III
- ClinicalTrials.gov ID
- NCT03780595
- Acronym / sponsor ID
- SEDISTRESS / SEDISTRESS
- Conditions
- Benzodiazepine Withdrawal (Disorder)
- Keywords
- Benzodiazepine, Withdrawal, passiflora
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Nutricion Medica S.L.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passiflora | Experimental | Drug: Passiflora incarnata |
| Control | Placebo comparator | Drug: Control |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- Diagnosis of dementia moderate or severe (Test Minimental ≤ 20).
- Acute confusional syndrome at the inclusion
- Panic disorder
- Obsesive-compulsive disorder
- Any type of psycosis or bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passiflora incarnataPassiflora pills administration up to 6 pills per day | Drug | Passiflora |
| ControlControl pills administration up to 6 pills per day | Drug | Control |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
Related trials for Benzodiazepine Withdrawal (Disorder)
Recruiting
Brief Motivational Intervention (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users
Benzodiazepine Withdrawal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Fernando Agüera principal investigator
Hospital Universitario 12 de Octubre
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Passiflora incarnata in people with Benzodiazepine Withdrawal (Disorder), run by Nutricion Medica S.L. at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María de Andres (+34 913 14 92 71, mariade.andres@nutricionmedica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018; AzTrials last refreshed its copy on 26 Oct 2026.