Depression study: Antidepressant medication
Official title Treatment Interrupts Depression Early
ClinicalTrials.gov ID: NCT05002309
What this study is testing
What is Antidepressant medication (ADM)?
An investigational antidepressant medication being studied for the treatment of depression in adolescents and young adults.
Also referred to as fluoxetine, sertraline, escitalopram.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see which treatment, talk therapy or antidepressant medication, helps people with new depression more, and whether personal factors can predict the best choice.
- Who it's for
- Adolescents and young adults aged 12 to 25 who have not yet been treated for a recent episode of major depression.
- What's involved
- Participants will be randomly assigned to either individual cognitive‑behavioral therapy or an optimized antidepressant regimen. They will receive the chosen treatment for up to one year and then be followed for two more years with regular visits and assessments of mood, daily functioning, and life milestones.
- Time commitment
- The study lasts up to three years: up to one year of treatment plus two years of follow‑up, with scheduled visits and tests throughout.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 25
You may be able to join if
- Age 12-25 years
- Diagnosis of major depressive disorder, onset of the major depressive disorder within the last 12 months.
- An additional inclusion criterion for entering Stage 1 (active intervention) is a minimum moderate depression severity (CDRS-R≥40
- Verbal ability sufficient to participate in psychological treatment.
You likely can't join if
- Personal history of a manic or hypomanic episode, diagnosis of a psychotic disorder, pervasive developmental disorder or autism spectrum disorder...
- Previous trial of any treatment for major depressive disorder lasting 4 weeks or longer, current use of antipsychotic, antidepressant or...
- Recent (past 6 weeks) change in any psychotropic medication (including stimulants, hypnotics, anxiolytics) or receipt of 4 of more sessions of...
- Pregnancy or breastfeeding. If participants become pregnant or learn of pregnancies during the study, we will consult with Dr.
- No one will be excluded based on sex, gender, race, ethnicity, or living arrangements.
The study team makes the final eligibility decision.
Where it is enrolling
- Halifax, Nova Scotia, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Halifax, Nova Scotia, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.