Treatment for Cognitive Impairment in Depression

• Status: Withdrawn
• Trial end date: 2024-11-30
• Target enrollment: 0
• Participant gender: All

Summary

The proposed study seeks to investigate the effects of modafinil on cognitive function in depression, which holds promise for better treating cognitive impairment in depression, as well as better understand cognitive dysfunction in MDD from a neural rather than diagnostic point of view to better classify and treat these disabling symptoms.

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

Details

• Lead Sponsor: Stanford University
• Treatments: Modafinil

Criteria

Inclusion Criteria:

• 18-50 years of age (inclusive)

• Fluent and literate in English, and show non-impaired intellectual abilities to ensure adequate comprehension of the task instructions

• Meet diagnostic criteria for major depressive disorder

• Experiencing cognitive impairment attributed to depression that perform less than 0.5 standard deviations below the norm on a minimum of two cognitive domains on baseline cognitive testing

• Medication naïve to Modafinil. (Subjects can previously have been treated on antidepressants. If their usual treating physician is supportive, participants who are currently on an antidepressant can be tapered off the antidepressant to participate.)

• Written, informed consent

• MRI scanning eligibility, including no evidence of any form of metal embedded in the body (e.g., metal wires, nuts, bolts, screws, plates, sutures), as these produce artifacts when brain imaging. All potential subjects will need to successfully complete the screening forms at the Stanford Center for Cognitive and Neurobiological Imaging (CNI).

Exclusion Criteria:

• Current Axis 1 psychiatric disorder other than major depressive disorder

• Concurrent participation in other intervention or treatment studies

• Severe impediment to vision, hearing and/or hand movement, likely to interfere with ability to complete the assessments, or are unable and/or unlikely to follow the study protocols

• Impaired decision-making capacity

• Medical/neurological illness that result in cognitive impairment

• Current or prior use of psychotropic medications

• Body Mass Index outside healthy range (18-30).

• Magnetic resonance contraindication

• History of alcohol or substance (e.g., sedative-hypnotics, cannabis, stimulants, opioids, cocaine, hallucinogens) abuse or dependence

• Lifetime history of medical illness that may compromise cognitive functioning (including neurological disorders such as seizures or stroke, Parkinson's disease, dementia)

• History of head injury with loss of consciousness

• History of mental retardation

• Active suicidal ideation or history of suicide attempt in past year

• Treatment-resistant hypertension or any known cardiovascular disease

• Women who are pregnant or breastfeeding

• Kidney or liver function impairment

• Taking any medication contraindicated with modafinil including hormonal contraceptives, anticonvulsants (e.g. diazepam, phenytoin), propranolol, warfarin, drugs that are metabolized by CYPC19 or CYP3A enzymes.