Antidepressants for Depression
Palo Alto (17 mi)Overseen byDiego A. Pizzagalli, PhD
Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Mclean Hospital
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The main goal of this research is to use behavioral, brain, and clinical data to determine which type of antidepressant might be optimal before people with depression start treatment.
Eligibility Criteria
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.Inclusion Criteria
I have been diagnosed with Major Depressive Disorder.
My vision and hearing are normal, or corrected to be normal.
I am between 18 and 64 years old.
Exclusion Criteria
I do not have serious heart problems as confirmed by an ECG.
I do not have any serious or unstable illnesses.
I have tried sertraline and bupropion without improvement.
I am receiving or have received electroconvulsive therapy for my current health condition.
I used marijuana regularly before I turned 15.
I have had bad reactions or am considered unsafe to take bupropion or sertraline.
I have tried at least two antidepressants without improvement.
I am pregnant or might be pregnant.
I have hemophilia, poorly controlled diabetes, chronic migraines, or a history of dementia.
I have had a severe head injury or concussion with significant aftereffects.
I haven't taken any blood flow or pressure medication in the last 3 weeks.
I have a history of seizures.
I have taken Metformin in the last 6 months.
Treatment Details
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.
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.
Bupropion is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Wellbutrin for:
- Major depressive disorder
- Seasonal affective disorder
- Smoking cessation
🇪🇺 Approved in European Union as Wellbutrin for:
- Major depressive disorder
- Seasonal affective disorder
- Smoking cessation
🇨🇦 Approved in Canada as Zyban for:
- Smoking cessation
🇦🇺 Approved in Australia as Wellbutrin for:
- Major depressive disorder
- Seasonal affective disorder
- Smoking cessation
Find a clinic near you
Research locations nearbySelect from list below to view details:
McLean HospitalBelmont, MA
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Who is running the clinical trial?
Mclean HospitalLead Sponsor