UnknownPhase 4

Passiflora Extract for Benzodiazepine Withdrawal

Spain108 participantsStarted 2018-09-27

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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
. Current or past diagnosis of epilepsia
. Recent stroke (last month)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To compare the percentage of patients who achieve to reduce the dose of benzodiazepines equal or more than 50% Reduction of the benzodiazepine dose

Timeframe: 10 weeks of treatment

Trial details

NCT IDNCT03780595

SponsorNutricion Medica S.L.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06-30

Contact for this trial

María de Andres

+34 913 14 92 71 mariade.andres@nutricionmedica.com

View on ClinicalTrials.gov More Benzodiazepine Withdrawal (Disorder) trials