DeliriumPhase 3NCT02028260
Modafinil Versus Placebo for Hypoactive Delirium in the Critically Ill
A Phase 3 study testing Modafinil in people with Delirium and Respiratory Failure, run by Brigham and Women's Hospital at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Delirium, Respiratory Failure
- What is being tested?
- Modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Oct 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Pregnancy
- Alcohol withdrawal
- History of end stage liver disease (Childs-Pugh class B or worse)
- Prognosis considered hopeless (CMO)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Modafinil vs. Placebo for Hypoactive Delirium in the Critically Ill: A Randomized, Controlled Trial
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.
Read the detailed 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)
- Conditions
- Delirium, Respiratory Failure
- Being tested
- Modafinil, Placebo
- Medical subject headings
- Delirium, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
Also called provigil
200 mg daily
PlaceboDrug
similar appearing inert tablet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Modafinil |
| Placebo | Placebo comparator | normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased CAM positive days in the ICU
Measured: Up to 14 days of ICU stay
Secondary outcomes (1)
Length of stay in the ICU
Measured: Up to 14 days of ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2015 (estimated)
- Study completionOct 2015
Why it stopped: unable to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerald L. Weinhouse, Brigham and Women's Hospital
- Investigators
- Gerald L Weinhouse, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028260
- Sponsor's protocol ID
- 2013P002105
- Status last verified
- Nov 2016
- First submitted
- 19 Dec 2013
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modafinil vs. Placebo for Hypoactive Delirium in the Critically Ill: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02028260
- Acronym / sponsor ID
- 2013P002105
- Conditions
- Delirium, Respiratory Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modafinil | Active comparator | Drug: ModafinilModafinil 200 mg qAM enterally for the duration the patient is confirmed to be in a hypoactive delirium to a maximum of 14 days. |
| Placebo | Placebo comparator | Drug: Placebonormal saline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ModafinilAlso: provigil200 mg daily | Drug | Modafinil |
| Placebosimilar appearing inert tablet | Drug | Placebo |
Primary outcome
Decreased CAM positive days in the ICU
Time frame: Up to 14 days of ICU stay
1 secondary outcome
Length of stay in the ICU
Time frame: Up to 14 days of ICU stay
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald L Weinhouse, MD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modafinil in people with Delirium and Respiratory Failure, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased CAM positive days in the ICU (time frame: Up to 14 days of ICU stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016.