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Trial record 20 of 239 for:    (armodafinil)

Modafinil's Effects on Cognition in Remitted MDD

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ClinicalTrials.gov Identifier: NCT03620253
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborators:
Ontario Ministry of Health and Long Term Care
The Canadian Biomarker Integration Network in Depression
Information provided by (Responsible Party):
Shane McInerney, St. Michael's Hospital, Toronto

Brief Summary:
Cognitive difficulties such as indecisiveness or inability to concentrate are core symptoms of depression with up to 90% of untreated depressed individuals experiencing these symptoms. As many as half of those who remit from a major depressive episode continue to experience residual cognitive deficits, but these symptoms are frequently overlooked in clinical practice. This leads to persistent cognitive deficits which can cause reduced level of functioning and loss of productivity. As standard antidepressants have an inadequate impact on these residual cognitive symptoms, further treatment options are required. Modafinil is a wakefulness agent with evidence that it improves some domains in cognition such as memory in those whose non-cognitive depressive symptoms have been treated over a short term period. This medication may have favourable lasting effects on cognition, such as the ability to plan and execute tasks in those who receive modafinil for a longer time period. The aim of this study is to investigate whether modafinil can enhance cognition and have additional effects on functioning and work productivity in a sample of participants who were treated for depression but who continue to experience cognitive deficits.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Cognitive Impairment Drug: Modafinil Drug: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 50 Participants (aged 18-55) who are experiencing cognitive deficits (measured as Neurocognitive Index >1 standard deviation below the mean) despite remission from depression (Montgomery-Asberg Rating Scale for Depression (MADRAS) score <7) will be eligible to receive modafinil (100-200mg daily) or two identical placebo capsules each morning for a period of 8 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 25 participants will be randomly assigned to the modafinil treatment group, and 25 to the placebo group. The drug/placebo will be randomized and dispensed by the research pharmacy at St. Michael's Hospital. A research technician who is blind to the study will prepare the capsules and break the blind at the end of the study.
Primary Purpose: Treatment
Official Title: Does Modafinil Have Pro-cognitive Effects in Those With Residual Cognitive Impairment Despite Remitted Depression?
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Modafinil
Participants will be administered 100 mg modafinil tablets, that will be over-encapsulated, for one week. If the drug is well tolerated, the dosage will be increased to 200 mg for the remaining 7 weeks of the study. Capsules are taken daily in the morning.
Drug: Modafinil
Participants randomized to the modafinil group will receive 100 mg of modafinil capsules for 1 week, followed by 200 mg for 7 weeks (as long as the drug is well tolerated), which they will take daily in the morning. During this time, participants will complete questionnaires and neurocognitive tests, and report adverse events at study visits.
Other Names:
  • Provigil
  • Alertec
  • 2-benzhydrylsulfinylacetamide

Placebo Comparator: Placebo
Participants will be administered 100 mg placebo capsule. This capsule will have all the same ingredients as the modafinil tablets, minus the active ingredient. After 1 week, participants' dosage will be increased to 200 mg for the remaining 7 weeks of the study. Capsules are taken daily in the morning.
Drug: Placebo
Participants randomized to the placebo group will receive 100 mg placebo capsules for 1 week, followed by 200 mg for 7 weeks, which they will take daily in the morning. During this time, participants will complete questionnaires and neurocognitive tests, and report adverse events at study visits.




Primary Outcome Measures :
  1. Cognition [ Time Frame: 8 weeks ]
    Cognition will be measured using a Neurocognitive Index, which will be calculated using the CNS Vital Signs Neurocognitive Battery (a computer program). The domains tested within the cognitive battery include composite memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, and processing speed. The Neurocognitive Index is based on a composite, average score of the scores on these 6 domains. From the Neurocognitive Index score, the CNS Vital Signs program classifies the participant as above, average, low average, low, or very low based on their deviation from a standard score of 85.


Secondary Outcome Measures :
  1. Composite Memory [ Time Frame: 8 weeks ]
    This is a measure of how well participants can recognize, remember, and retrieve words and images. Composite memory will be measured based on performance on a series of tests in the CNS Vital Signs Neurocognitive Battery (a computer program). Based on performance, the CNS Vital Signs program classifies the participant as above, average, low average, low, or very low based on their deviation from a standard score of 103.

  2. Psychomotor Speed [ Time Frame: 8 weeks ]
    This is a measure of how well a participant is able to perceive, attend, and respond to complex visual-perceptual information and perform simple, fine motor coordination. Psychomotor speed will be measured based on performance on a series of tests in the CNS Vital Signs Neurocognitive Battery (a computer program). Based on performance, the CNS Vital Signs program classifies the participant as above, average, low average, low, or very low based on their deviation from a standard score of 93.

  3. Reaction Time [ Time Frame: 8 weeks ]
    This is a measure of how quickly a participant can react to simple and complex direction sets. Reaction time will be measured based on performance on a series of tests in the CNS Vital Signs Neurocognitive Battery (a computer program). Based on performance, the CNS Vital Signs program classifies the participant as above, average, low average, low, or very low based on their deviation from a standard score of 107.

  4. Complex Attention [ Time Frame: 8 weeks ]
    This is a measure of a participant's ability to track and respond to multiple stimuli over long periods of time, and perform complex mental tasks quickly and accurately. Complex attention will be measured based on performance on a series of tests in the CNS Vital Signs Neurocognitive Battery (a computer program). Based on performance, the CNS Vital Signs program classifies the participant as above, average, low average, low, or very low based on their deviation from a standard score of 56.

  5. Cognitive Flexibility [ Time Frame: 8 weeks ]
    This is a measure of how well a participant can adapt to rapidly changing and complex directions, and manipulate information. Cognitive flexibility will be measured based on performance on a series of tests in the CNS Vital Signs Neurocognitive Battery (a computer program). Based on performance, the CNS Vital Signs program classifies the participant as above, average, low average, low, or very low based on their deviation from a standard score of 63.

  6. Processing Speed [ Time Frame: 8 weeks ]
    This is a measure of a participant's ability to recognize and process information. Processing speed will be measured based on performance on a series of tests in the CNS Vital Signs Neurocognitive Battery (a computer program). Based on performance, the CNS Vital Signs program classifies the participant as above, average, low average, low, or very low based on their deviation from a standard score of 79.

  7. Subjective Cognitive Improvement [ Time Frame: 8 weeks ]
    This is a measure of how well the participant feels their cognition has improved after using the study drug. This will be measured using the British Columbia Cognitive Complaints Inventory, a 6-item screening tool that assesses perceived cognitive difficulties in patients with MDD over the past 7 days. A total score between 0 and 18 is calculated based on participant self-report, where a higher score represents greater cognitive impairment.

  8. Functional Disability [ Time Frame: 8 weeks ]
    This will be assessed using the Sheehan Disability Scale, which assesses functional impairment in work/school, social life, and family life. This is scored based on a self-report scale of 0-10 in 3 domains: work/school, social life, and family life/home responsibilities. A total score between 0 and 30 is calculated based on the sum of these 3 domains. Higher values represent greater disability.

  9. Work Productivity [ Time Frame: 8 weeks ]
    This will be assessed using the Lam Employment and Productivity Scale, a brief questionnaire designed to assess occupational productivity.This is scored based on a self-report scale from 0-4 in 7 domains: low energy or motivation, poor concentration or memory, anxiety or irritability, getting less work done, doing poor quality work, making more mistakes, and having trouble getting along with people or avoiding them. A total score between 0 and 28 is calculated as a sum of all sub scores. Higher values represent greater impairment.

  10. Motivation and Energy [ Time Frame: 8 weeks ]
    This is be assessed using the Motivation and Energy Inventory, an 18-item inventory to measure changes in lassitude and energy with antidepressant treatment. Based on self-report measurements, a total score between 0-108 is determined, where a lower score corresponds to lower levels of motivation and energy.


Other Outcome Measures:
  1. Overall Quality of Life [ Time Frame: 8 weeks ]
    This will be assessed using the World Health Organization Quality of Life, Shortened Version. A score between 4 and 20 is determined for four domains: physical health, psychological health, social relationships, and environment. A total score for overall quality of life between 16 and 80 is then calculated as the sum of these four domain scores. A higher score represents greater quality of life.

  2. Life Enjoyment and Satisfaction [ Time Frame: 8 weeks ]
    This is measured using the Quality of Life Enjoyment and Satisfaction Questionnaire, a depression-specific quality of life measure. This questionnaire is scored using 8 domains: physical health/activities (possible score between 13-65), feelings (total score between 14-70), work (total score between 13-65), household duties (total score between 10-50), school/course work (total score between 10-50), leisure time activities (total score between 6-30), social relations (total score between 11-55), and overall satisfaction (total score between 12-60). Lower scores represent lower levels of enjoyment and satisfaction.

  3. Sleepiness [ Time Frame: 8 weeks ]
    This will be assessed using the Epworth Sleepiness Scale, an 8-item scale used as a subjective measure of a patient's sleepiness. A total score between 0 and 24 is calculated based on the participant's self-report, where higher scores represent greater sleepiness.

  4. Fatigue [ Time Frame: 8 weeks ]
    This will be assessed using the Fatigue Severity Scale, a 9-item questionnaire with questions related to how fatigue interferes with certain activities. A total score between 9 and 63 is calculated based on the participant's self-report, where higher scores represent greater levels of fatigue.

  5. Sleep Quality [ Time Frame: 8 weeks ]
    This will be assessed using the Pittsburgh Sleep Quality Index, which assesses night-time sleep problems, focusing on sleep experiences over the past month. A total score between 0 and 21 is assigned, where higher scores represent worse sleep quality.

  6. Depressive Symptomatology [ Time Frame: 8 weeks ]
    This will be assessed using 2 measures. The first is the Quick Inventory of Depressive Symptomatology, a 6-item measure of MDD symptom severity; a total score between 0-27 is possible for this questionnaire based on participant self-report. The second measure is the Montgomery-Asberg Depression rating scale, a clinician-administered 10-item scale that incorporates symptoms most sensitive to change; a total score of 0-60 is possible. Both of these scores will be converted to percentages (i.e. participant score divided by total possible score) and then averaged to get a final percentage representing depressive symptoms. A higher score represents a higher degree of depressive symptoms.

  7. Anxiety Symptomatology [ Time Frame: 8 weeks ]
    Th is measured using the Generalized Anxiety Disorder 7-Item, an anxiety scale used for assessing anxiety severity. A total score is calculated based on 7 questions (each of which are self-rated on a scale of 0 to 3) for a total score between 0 and 21. Higher scores represents a higher degree of anxiety symptoms.

  8. Psychiatric Symptomatology [ Time Frame: 8 weeks ]
    This will be assessed using the Brief Symptom Inventory-53, which assesses the psychological profile of an individual covering somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. A global severity index is determined as the mean score on the 53 questions on this inventory. Each question is self-rated by the participant on a scale of 0 to 4, and a total score of 0 to 4 is possible for the global severity index. A higher score represents a higher degree of psychiatric symptoms.

  9. Treatment Satisfaction (with study drug) [ Time Frame: 8 weeks ]
    This will be assessed by administering the Abbreviated Treatment Satisfaction Questionnaire for Medication, a 9-item questionnaire evaluating patient satisfaction with medication treatment in a study. A total score of 9 to 59 is possible, where higher scores represent greater treatment satisfaction.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnostic and Statistical Manual (DSM)-5 criteria for past Major Depressive Episode within MDD, confirmed through Mini-International Neuropsychiatric Interview (MINI) diagnosis
  2. Age between 18 and 55 years
  3. Montgomery-Åsberg Depression Rating Scale < 7 (in remission)
  4. Ability to read and understand English
  5. Participant has been treated with an antidepressant for ≥ 6 months prior to enrolment
  6. Participant agrees to remain on a stable antidepressant regimen for the duration of the trial (8 weeks)
  7. Participant is currently experiencing cognitive deficits, as confirmed by an NCI >1 standard deviation below the mean on CNS Vital Signs cognitive battery
  8. Women of child bearing potential must agree to use birth control for the duration of the study and 1 month following discontinuation of the study drug

Exclusion Criteria:

  1. Pregnancy/lactation
  2. Lifetime history of Bipolar I, II or psychosis; other comorbidities (e.g. Generalized Anxiety, Panic Disorder) may be allowed by clinician judgement
  3. Subject has current clinical diagnosis of autism, dementia, intellectual disability, or mild cognitive impairment
  4. Meets DSM-5 criteria for active Post-Traumatic Stress Disorder, confirmed through MINI diagnosis
  5. Subject meets criteria for current personality disorder
  6. Concomitant use of monoamine oxidase inhibitors and/or other psychotropic drugs including lithium, clomipramine, and triazolam
  7. Recent (< 6 months) stimulant use, such as medications used for attention deficit hyperactivity disorder
  8. Subject is taking antipsychotics
  9. Subject is taking herbaceuticals (i.e. natural products that have psychoactive properties, such as St. John's wort)
  10. Concomitant use of medications that may interact with modafinil, including warfarin and cyclosporine
  11. Medical condition requiring immediate investigation or treatment
  12. Recent (< 6 months)/current history of drug abuse/dependence (other than caffeine or nicotine)
  13. Previous intolerance or failure to respond to an adequate trial of modafinil
  14. Any past history of head injury or concussion, as confirmed by the Ohio State University Traumatic brain injury (TBI) Identification Short Form
  15. Current suicidal ideation (MADRS Item 10 ≤2 or by clinician judgement)
  16. History of coronary artery disease, recent (<1 year) myocardial infarction, or unstable angina
  17. History of left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, or clinically significant manifestations of mitral valve prolapse in association with use of CNS stimulants
  18. Involvement in another treatment study during the time of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620253


Contacts
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Contact: Shane McInerney, MD 416-864-6060 ext 6483 mcinerneys@smh.ca
Contact: Sophie R Vaccarino, BScH vaccarinos@smh.ca

Locations
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Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B1W8
Contact: Shane McInerney, MD    4168646060 ext 6483    mcinerneys@smh.ca   
Contact: Sophie R Vaccarino, BScH       vaccarinos@smh.ca   
Principal Investigator: Shane McInerney, MD         
Sub-Investigator: Sindey H Kennedy, MD         
Sub-Investigator: Venkat Bhat, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Ontario Ministry of Health and Long Term Care
The Canadian Biomarker Integration Network in Depression
Investigators
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Principal Investigator: Shane McInerney, MD St. Michael's Hospital, Toronto

Publications:

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Responsible Party: Shane McInerney, Staff Psychiatrist, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03620253     History of Changes
Other Study ID Numbers: MOCOG-01
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Shane McInerney, St. Michael's Hospital, Toronto:
modafinil
remitted depression
cognition

Additional relevant MeSH terms:
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Modafinil
Depressive Disorder
Depression
Depressive Disorder, Major
Cognitive Dysfunction
Mood Disorders
Mental Disorders
Behavioral Symptoms
Cognition Disorders
Neurocognitive Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action