← Back to Search

Norepinephrine-Dopamine Reuptake Inhibitor

Antidepressants for Depression

Phase 4
Recruiting
Led By Diego A. Pizzagalli, PhD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Elevated anhedonia symptoms
Diagnosis of Major Depressive Disorder (MDD) via the Structured Clinical Interview for DSM-5 (SCID-5)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8-10 weeks
Awards & highlights

Study Summary

This trial will help researchers understand how different types of antidepressants affect people with depression before treatment begins.

Who is the study for?
Adults aged 18-64 with Major Depressive Disorder and high anhedonia symptoms, fluent in English, with good vision/hearing. Must be right-handed and able to consent to the study. Excludes pregnant women, those with metal implants or severe medical conditions, substance abuse issues, certain mental health disorders, history of adverse reactions to trial drugs (Sertraline/Bupropion), treatment-resistant depression or specific medication use.Check my eligibility
What is being tested?
The SMART Trial is testing whether Sertraline or Bupropion is more effective for treating anhedonia in depression. It uses behavioral assessments and brain imaging to predict which antidepressant will work best before starting treatment.See study design
What are the potential side effects?
Possible side effects include nausea, headaches, dry mouth for Sertraline; seizures risk (rare), dry mouth, insomnia for Bupropion. Both can cause changes in weight/appetite and mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I feel a lack of pleasure in activities I used to enjoy.
Select...
I have been diagnosed with Major Depressive Disorder.
Select...
My vision and hearing are normal, or corrected to be normal.
Select...
I am between 18 and 64 years old.
Select...
My gender or ethnic background does not limit my participation.
Select...
I am experiencing severe depression.
Select...
My vision and hearing are normal, or corrected to be normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8-10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mental Depression
Secondary outcome measures
Cortico-insular activation during an effort-based task
Effort-based decision making during an effort-based task
Resting state functional connectivity between the NAc and mPFC during an fMRI scan
+2 more

Side effects data

From 2002 Phase 4 trial • 110 Patients • NCT00000378
3%
orthostatic hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sertaline
Nortriptyline

Trial Design

2Treatment groups
Experimental Treatment
Group I: MDD with SERT+ Response MarkerExperimental Treatment2 Interventions
Participants with MDD who have been classified as high sertraline responders based on behavioral and brain data.
Group II: MDD with BUP+ Response MarkerExperimental Treatment2 Interventions
Participants with MDD who have been classified as high bupropion responders based on behavioral and brain data.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sertraline
2002
Completed Phase 4
~5470
Bupropion
2011
Completed Phase 4
~3310

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor
212 Previous Clinical Trials
21,417 Total Patients Enrolled
46 Trials studying Depression
3,531 Patients Enrolled for Depression
Diego A. Pizzagalli, PhDPrincipal InvestigatorMclean Hospital
2 Previous Clinical Trials
187 Total Patients Enrolled
2 Trials studying Depression
187 Patients Enrolled for Depression

Media Library

Bupropion (Norepinephrine-Dopamine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05537584 — Phase 4
Depression Research Study Groups: MDD with BUP+ Response Marker, MDD with SERT+ Response Marker
Depression Clinical Trial 2023: Bupropion Highlights & Side Effects. Trial Name: NCT05537584 — Phase 4
Bupropion (Norepinephrine-Dopamine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05537584 — Phase 4
Depression Patient Testimony for trial: Trial Name: NCT05537584 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Sertraline earned market authorization from the FDA?

"Sertraline has been approved by the appropriate authorities and is thus rated with a 3 on our scale. This signifies that it can be used in Phase 4 trials with confidence as regards safety."

Answered by AI

What qualifications must be met for potential participants of this research?

"To meet the requirements for this medical study, prospective patients must be suffering from major depressive disorder (mdd) and aged between 18-64. The current recruitment target is 183 participants."

Answered by AI

Does this study include octogenarians as participants?

"The age range for participants of this trial is delineated in the inclusion criteria; with a minimum age requirement of 18 and an upper limit at 64."

Answered by AI

Are there any vacancies left to join this clinical experiment?

"This trial, which was initially posted on September 30th 2022 and last updated a month later on the 8th of September, is not actively seeking new participants. Nevertheless, there are 840 other clinical trials that still require enrolment at this moment in time."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What site did they apply to?
McLean Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Earn $$. Get relief from depression.
PatientReceived 1 prior treatment
~51 spots leftby Nov 2024