NCT04122599

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2018

Enrollment Period

2.3 years

First QC Date

May 29, 2019

Last Update Submit

October 9, 2019

Conditions

Post Stroke Delirium

Keywords

Melatonin

Outcome Measures

Primary Outcomes (1)

  • Change of delir prevalence

    3months

Secondary Outcomes (3)

  • Change of hospital stay

    3months

  • Change of antipsychotic drug administration

    3 months

  • Changed stay on stroke unit and/or intermediate care

    3 months

Study Arms (1)

Melatonin versus standard care

OTHER

Melatonin is tested versus standard care

Drug: Melatonin

Interventions

MelatoninDRUG

Melatonin for prevent post stroke delirium

Melatonin versus standard care

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • RASS \<=4
  • severe dementia, psychosis or depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Neurologie

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Annerose Mengel, MD

CONTACT

004970712985354annerose.mengel@med.uni-tuebingen.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2019

First Posted

October 10, 2019

Study Start

July 1, 2017

Primary Completion

November 1, 2019

Study Completion

December 31, 2019

Last Updated

October 10, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)