Melatonin for Prevention of Post Stroke Delirium

October 9, 2019 updated by: University Hospital Tuebingen
Post stroke delirium is prevalent in 10-30% of all stroke patients. We aimed to investigate wether Melatonin 2mg may prevent post stroke delirium.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Melatonin versus standard care
Melatonin is tested versus standard care
Drug: Melatonin
Melatonin for prevent post stroke delirium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of delir prevalence
Time Frame: 3months
3months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of hospital stay
Time Frame: 3months
3months
Change of antipsychotic drug administration
Time Frame: 3 months
3 months
Changed stay on stroke unit and/or intermediate care
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

May 29, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 9, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 752/2018BO2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Stroke Delirium

Clinical Trials on Melatonin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe