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Norepinephrine-Dopamine Reuptake Inhibitor

Antidepressants for Depression (NBOLD Trial)

Phase 4
Recruiting
Led By David Steffens, M.D., M.H.S.
Research Sponsored by David Steffens
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Major depression, single episode or recurrent
Be older than 18 years old
Must not have
Conditions associated with brain abnormalities such as hydrocephalus, benign and cancerous brain tumors, epilepsy, Parkinson's disease, Huntington's chorea, dementia, demyelinating diseases, etc.
Untreated endocrine disorder other than diabetes mellitus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three years
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 10 Other Conditions
Drug Has Already Been Approved

Summary

This trial will focus on stress' effect on long-term mood and cognitive outcomes in adults with late-life depression.

Who is the study for?
This trial is for older adults who can read and write English, have a score above 25 on the Mini-Mental State Examination, and are experiencing major depression. It's not suitable for those with lifetime alcohol/drug dependence, untreated endocrine disorders (except diabetes), dementia, or significant brain abnormalities.
What is being tested?
The study examines how stress affects mood and cognitive outcomes in late-life depression using medications like Sertraline, bupropion, desvenlafaxine. It includes brain imaging to understand the neural basis of these changes.
What are the potential side effects?
Potential side effects from medications such as Sertraline may include nausea, sleepiness or insomnia, headache and sexual dysfunction; bupropion might cause dry mouth, headaches or weight loss; desvenlafaxine could lead to dizziness, insomnia or abnormal sweating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with major depression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition related to brain abnormalities like epilepsy or Parkinson's.
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I have an untreated hormone-related condition, but it's not diabetes.
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I have been diagnosed with dementia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three years
This trial's timeline: 3 weeks for screening, Varies for treatment, and three years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cognitive clinical diagnosis
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Neuropsychological Battery Total Score
Montgomery-Asberg Depression Rating Scale (MADRAS)
Secondary study objectives
Functional brain magnetic resonance imaging (fMRI) scan changes in resting state functional connectivity.
Functional brain magnetic resonance imaging (fMRI) scan structural imaging changes
Other study objectives
Neuroticism subtest score on NEO Personality Inventory

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DepressedExperimental Treatment1 Intervention
Subjects receive FDA-approved antidepressants

Find a Location

Who is running the clinical trial?

David SteffensLead Sponsor
National Institute of Mental Health (NIMH)NIH
2,913 Previous Clinical Trials
2,738,460 Total Patients Enrolled
699 Trials studying Depression
260,856 Patients Enrolled for Depression
David Steffens, M.D., M.H.S.Principal InvestigatorUConn Health

Media Library

Bupropion (Norepinephrine-Dopamine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05273996 — Phase 4
Depression Research Study Groups: Depressed
Depression Clinical Trial 2023: Bupropion Highlights & Side Effects. Trial Name: NCT05273996 — Phase 4
Bupropion (Norepinephrine-Dopamine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05273996 — Phase 4
~25 spots leftby Jun 2026
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