Melatonin for Prevention of Post Stroke Delirium

NCT ID: NCT04122599

Last Updated: 2019-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Post stroke delirium is prevalent in 10-30% of all stroke patients. We aimed to investigate wether Melatonin 2mg may prevent post stroke delirium.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Stroke Delirium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Melatonin versus standard care

Melatonin is tested versus standard care

Group Type OTHER

Melatonin

Intervention Type DRUG

Melatonin for prevent post stroke delirium

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Melatonin

Melatonin for prevent post stroke delirium

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* all patients with stroke, TIA or ICH admitted to our stroke unit or intemdiate care unit
* Stroke / ICH /TIA onset \<= 48h

Exclusion Criteria

* RASS \<=4
* severe dementia, psychosis or depression
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Klinik für Neurologie

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Annerose Mengel, MD

Role: CONTACT

004970712985354

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Annerose Mengel, MD

Role: primary

Christian Bosselmann, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

752/2018BO2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Melatonin in Acute Stroke
NCT03843008 WITHDRAWN NA
Modafinil and Exercise for Post Stroke Fatigue
NCT06354985 NOT_YET_RECRUITING PHASE3
Better Understanding of Fatigue After STroke
NCT06292377 NOT_YET_RECRUITING NA