BridgeMD
A 6-Week, Multicenter, Open-Label, Monotherapy, Extension Study of SPT-300 in Adults with Major Depressive Disorder, With or Without Anxious Distress
EU CTIS ID: 2025-522347-18-00
What this study is testing
To evaluate the safety and tolerability of oral doses of SPT 300 in participants with MDD, with or without anxious distress
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant who completed treatment in Study SPT-300-2024-203-OUS (ie, participant who competed Visit 6 [Day 42] of Study SPT-300-2024-203-OUS)
- Participant must be able, willing, and have capacity to provide written informed consent prior to any study procedures and should agree to comply with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP must agree to use at least an acceptable form of highly effective contraception during participation in the study and for 30 days after receiving the last dose of study treatment.
- Male participants and their female partners should agree to use at least an acceptable method of effective contraception for the duration of study and for at least 30 days after receiving the last dose of the study treatment.
- Participant is willing and able to refrain from the use of drugs of abuse (including recreational cannabinoids/medical cannabinoids) and alcohol for the duration of the study.
- Willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures and requirements.
You likely can't join if
- Participants who, in the opinion of the Investigator, medical monitor, or Sponsor, should not participate in the study.
- Participants who, in the judgment of the Investigator, were noncompliant with trial procedures or with study treatment administration during the double-blind study.
- Female participants with a positive urine pregnancy test result. Female participants may be enrolled without a negative urine test if they are surgically sterile or at least 2 years post-menopause.
The study team makes the final eligibility decision.
Where it's taking place
- United States
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 - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.