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Study Summary
This trial is to study the safety and tolerability of a new drug for people with Bipolar I Depression. It is a year-long study being conducted at 90 centers worldwide.
- Bipolar Depression
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Group 1: SEP-4199 CR
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this experiment only use elderly test subjects?
"The age range for participants in this trial are those aged 18 to 65."
What is the SEP-4199 CR FDA approval status?
"There is some evidence from prior clinical trials to support the efficacy of SEP-4199 CR, and it has thus been given a safety rating of 3."
Are there still places available for participants in this experiment?
"This particular clinical trial, which was first made public on March 17th 2022 is not recruiting patients at this moment. The last update to the study's page on clinicaltrials.gov occurred on November 1st of the same year. Although this specific study isn't looking for volunteers presently, there are many other trials (1,350 in total) that are actively searching for candidates right now."
Is this research project being conducted at multiple sites within the United States?
"There are a total of 13 different clinical trial sites recruiting patients for this study, with locations inJacksonville, Orlando, Lincoln and 10 other cities. To minimize travel requirements, it is best to select the nearest location to you."
Who would be an ideal candidate for this clinical trial?
"This clinical trial is looking for 355 participants who have melancholia and meet the following additional inclusion criteria: between 18-65 years old, female subjects must be willing to use contraception throughout the study and for 30 days after taking the last dose of medication, agree to comply with the protocol, completed 6 weeks of double-blind treatment from Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR, appropriate for long-term open-label treatment with SEP-4199 CR, male subjects agree to avoid fathering a child and use birth control methods throughout the study until 90 days after taking"
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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