Treatment for Cognitive Impairment in Depression

NCT04317001 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: 46217
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Major Depressive Disorder

Keywords

cognition

Outcome Measures

Primary Outcomes (1)

• Change in Depression, Anxiety and Stress Scale (DASS)

  A 42-item self report scale that can be considered in the context of depression using the DASS depression scale.

  Day 1, Day 14 and Day 28

Study Arms (2)

Active treatment with modafinil

ACTIVE COMPARATOR

active intervention

Drug: Modafinil

Placebo

PLACEBO COMPARATOR

placebo intervention

Drug: Placebo

Interventions

Modafinil DRUG

Treatment will be with 100mg of modafinil for the two week primary phase of the study

Also known as: Provigil

Active treatment with modafinil

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

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

Model Details: Randomized double-blinded placebo control

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 20, 2020
• Study Start: December 1, 2018
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2024
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share