Modafinil's Effects on Cognition in Remitted MDD

• Status: Terminated
• Trial end date: 2019-08-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Michael's Hospital, Toronto; Unity Health Toronto
• Collaborators: Ontario Ministry of Health and Long Term Care; The Canadian Biomarker Integration Network in Depression
• Treatments: Armodafinil; Modafinil

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