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melatonin for Disorders of Consciousness

N/A
Waitlist Available
Led By Nicholas Schiff, MD
Research Sponsored by Rockefeller University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months
Awards & highlights

Study Summary

This trial will study whether melatonin can help improve the sleep of patients with severe brain injuries.

Eligible Conditions
  • Disorders of Consciousness

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in in sleep/wake architecture following melatonin administration as assessed by time domain analysis of sleep EEG
Secondary outcome measures
Medical Devices
Changes in wakeful behavior level
quantitative measures of EEG spectral content

Side effects data

From 2017 Phase 3 trial • 709 Patients • NCT00668707
16%
Fatgiue
11%
Insomnia
10%
Death
9%
Nausea
9%
Dyspnea
8%
Diarrhea
5%
Postoperative Pain
4%
Constipation
4%
Cough
3%
Vomiting
3%
Headache
3%
Peripheral Neuropathy
3%
Neutropenia
2%
Appetite changes
2%
Air Leak
2%
Dizziness
2%
Chest pain
2%
Cold/Flu Symptoms
1%
dry mouth
1%
Back pain
1%
Pneumothorax
1%
Flatulence
1%
Anemia
1%
Pneumonia
1%
New Neoplasm - Lung Cancer
1%
Weight loss
1%
Vertigo
1%
Anorexia
1%
Erythema
1%
Bonchitis
1%
Pulmonary embolism
1%
Gall bladder attack
1%
GERD
1%
Anxiety
1%
Tinnitus
1%
Depression
1%
Syncope
1%
Acid reflux
1%
Epistaxis
1%
Pruritis
1%
Rash
1%
Prolonged Air Leak
1%
Hyperglycemia
1%
Thrush (mouth)
1%
Hip replacement surgery
1%
Subcutaneous Emphysema
1%
Atrial fibrillation
1%
Indigestion
1%
Peripheral Edema
1%
C-Difficile
1%
Surgical site infection
1%
Fall
1%
Pain
1%
Radiation pneumonitis
1%
Surgical Site Pain
1%
Dry Cough
1%
Pleural effusion
1%
New Neoplasm
1%
Hypertension
1%
Tachycardia
1%
Dysphagia
1%
Sinus infection
1%
Myalgia
1%
Hearing loss
1%
Hemoptysis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: Melatonin, brain injured patientsExperimental Treatment1 Intervention
Melatonin 3mg, orally, at 8pm, daily for 3 months
Group II: Healthy volunteersExperimental Treatment1 Intervention
Melatonin 3mg, orally, at 8pm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
melatonin
2013
Completed Phase 3
~2260

Find a Location

Who is running the clinical trial?

Rockefeller UniversityLead Sponsor
158 Previous Clinical Trials
16,356 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,054 Previous Clinical Trials
1,316,615 Total Patients Enrolled
1 Trials studying Disorders of Consciousness
30 Patients Enrolled for Disorders of Consciousness
Nicholas Schiff, MDPrincipal InvestigatorWeill Cornell Medical College/ Rockefeller University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is age a deciding factor for enrolment into this research endeavor?

"This medical trial is seeking participants of age 18 or older yet younger than 65."

Answered by AI

Is it possible for me to join this research endeavor?

"To be eligible for inclusion, individuals must have semi-lucid cognizance and a chronological age between 18 to 65 years old. This trial is open to a total of 20 subjects."

Answered by AI

Is there still availability for prospective individuals to join this experiment?

"The trial in question is no longer recruiting, according to the clinicaltrials.gov page which was last updated on April 26th 2022. Despite this, there are still 333 other studies actively looking for participants at present."

Answered by AI
Recent research and studies
Annals of NeurologyJournal
Preservation of Electroencephalographic Organization in Patients with Impaired Consciousness and Imaging-based Evidence of Command-following
Forgacs, Peter B., Mary M. Conte, Esteban A. Fridman, Henning U. Voss, Jonathan D. Victor, and Nicholas D. Schiff. 2014. “Preservation of Electroencephalographic Organization in Patients with Impaired Consciousness and Imaging-based Evidence of Command-following”. Annals of Neurology. Wiley. doi:10.1002/ana.24283.
BrainJournal
Power and Coherence of Sleep Spindle Frequency Activity Following Hemispheric Stroke
Gottselig, J. M., C. L. Bassetti, and P. Achermann. 2002. “Power and Coherence of Sleep Spindle Frequency Activity Following Hemispheric Stroke”. Brain. Oxford University Press (OUP). doi:10.1093/brain/awf021.
Trends in NeurosciencesJournal
Coherent Oscillations and Short-term Plasticity in Corticothalamic Networks
Steriade, Mircea. 1999. “Coherent Oscillations and Short-term Plasticity in Corticothalamic Networks”. Trends in Neurosciences. Elsevier BV. doi:10.1016/s0166-2236(99)01407-1.
Behavioural Brain ResearchJournal
Phase Shifting the Human Circadian Clock Using Melatonin
Lewy, Alfred J., Saeeduddin Ahmed, and Robert L. Sack. 1995. “Phase Shifting the Human Circadian Clock Using Melatonin”. Behavioural Brain Research. Elsevier BV. doi:10.1016/0166-4328(96)00084-8.
~0 spots leftby Apr 2025
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