Modafinil Versus Placebo for Hypoactive Delirium in the Critically Ill

Delirium Clinical Trial

Official title:

Modafinil vs. Placebo for Hypoactive Delirium in the Critically Ill: A Randomized, Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02028260
• Other study ID #: 2013P002105
• Status: Withdrawn
• Phase: Phase 3
• First received: December 19, 2013
• Last updated: November 2, 2016
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: November 2016
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo controlled study of 30 patients. Patients who qualify, as per the inclusion criteria (RASS greater than -3, less then +1, CAM positive, present gastric access) will either be given 200mg of modafinil or an identical, indistinguishable placebo. The placebo and study drug will be distributed by the hospital pharmacy. Once enrolled, each patient will be reassessed every morning to determine appropriateness for drug administration. If the RASS is less than -3 (i.e. comatose) or greater then 0 modafinil will not be given. He/she will then be assessed each morning thereafter. Due to the stimulant-like actions of modafinil, the drug will be administered only in the morning. Patients will be assessed for delirium at least twice a day; trained personnel using the Confusion Assessment Method (CAM) will do the assessment. Qualification for a delirium free day will be no positive CAM screens for 24 hours following drug administration. Additional data such as days on mechanical ventilation and progression to tracheotomy will also be collected hypothesizing that patients who take modafinil will have a shorter time to extubation therefore avoiding the need for a tracheotomy. Post-discharge from the unit, but within 48 hours, patients will be asked to participate in a survey (The Richards-Campbell Sleep Questionnaire (RCSQ) assessing their perception of daytime and nighttime sleepiness in the intensive care unit as well as their overall perception of rest. Their functional capacity will also be evaluated at this time and compared to their pre-morbid baseline. The hypothesis tested is that Modafinil restores sleep cycle synchrony in the ICU therefore increasing delirium free days and improving ICU outcomes.

Description:

Eligibility Criteria

Inclusion Criteria To be eligible for study entry, subjects must satisfy these main criteria

Inclusion criteria:

3.1 Inclusion Criteria

• Adult patients ≥ 18 yrs of age, < 76 yrs of age

• Admitted to MICU (3B and 3C) or SICU (8C, 8D, 11C)

• Surrogate present to provide informed consent when patient is not able

• RASS score of >-3, < +1

• CAM positive

• Enteral access

3.2 Exclusion Criteria:

• Recent MI (within past 2 weeks)

• High risk of dysrhythmias (i.e. bundle branch block, QT prolongation, class IV HF, implanted device)

• Unable to tolerate enteral medication

• History of stimulant induced mania/psychosis

• Pre-existing neurologic disease

• Patients transferred from outside hospital

• Pregnancy

• Alcohol withdrawal

• History of end stage liver disease (Childs-Pugh class B or worse)

• Prognosis considered hopeless (CMO)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria

• Adult patients = 18 yrs of age, < 76 yrs of age

• Admitted to MICU (3B and 3C) or SICU (8C, 8D, 11C)

• Surrogate present to provide informed consent when patient is not able

• RASS score of >-3, < +1

• CAM positive

• Enteral access

Exclusion Criteria:

• Recent MI (within past 2 weeks)

• High risk of dysrhythmias (i.e. bundle branch block, QT prolongation, class IV HF, implanted device)

• Unable to tolerate enteric medication

• History of stimulant induced mania/psychosis

• Pre-existing neurologic disease

• Patients transferred from outside hospital

• Pregnancy

• Alcohol withdrawal

• History of end stage liver disease (Childs-Pugh class B or worse)

• Prognosis considered hopeless (CMO)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Delirium
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Drug:
• Modafinil
200 mg daily
• Placebo
similar appearing inert tablet

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients perception of their sleep pattern in the ICU		Up to 14 days of ICU stay	No
Other	Return to baseline activities of daily living (ADL's)		Up to 14 days of ICU stay	No
Other	Amount of psychotropic medication co-administered		Up to 14 days of ICU stay	No
Primary	Decreased CAM positive days in the ICU		Up to 14 days of ICU stay	No
Secondary	Length of stay in the ICU		Up to 14 days of ICU stay	No