Modafinil Versus Placebo for Hypoactive Delirium in the Critically Ill

NCT02028260 | Withdrawn Phase 3 DMC

• 1 other identifier: 2013P002105
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Delirium; Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Decreased CAM positive days in the ICU

  Up to 14 days of ICU stay

Secondary Outcomes (1)

• Length of stay in the ICU

  Up to 14 days of ICU stay

Other Outcomes (3)

• Patients perception of their sleep pattern in the ICU

  Up to 14 days of ICU stay

• Return to baseline activities of daily living (ADL's)

  Up to 14 days of ICU stay

• Amount of psychotropic medication co-administered

  Up to 14 days of ICU stay

Study Arms (2)

Modafinil

ACTIVE COMPARATOR

Modafinil 200 mg qAM enterally for the duration the patient is confirmed to be in a hypoactive delirium to a maximum of 14 days.

Drug: Modafinil

Placebo

PLACEBO COMPARATOR

normal saline

Drug: Placebo

Interventions

Modafinil DRUG

200 mg daily

Also known as: provigil

Modafinil

Placebo DRUG

similar appearing inert tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (2)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Delirium; Respiratory Insufficiency

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gerald L Weinhouse, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BWPO PHYSICIAN

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 7, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 3, 2016

Record last verified: 2016-11

Locations

US (2)