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NRX-101 for Depression, Bipolar Disorder (SBD-ASIB Trial)
SBD-ASIB Trial Summary
This trial will test whether a new drug is better than another drug at reducing symptoms of depression and suicidal ideation over a six-week period.
SBD-ASIB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSBD-ASIB Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SBD-ASIB Trial Design
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Who is running the clinical trial?
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- Those who are willing and able to continuously use one of the following methods of birth control during the course of the study, defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly: implants, injectable or patch hormonal contraception, oral contraceptives, IUD, double-barrier contraception, sexual abstinence will have their form of birth control documented at screening and pre-ketamine baseline.Your body weight is within a healthy range for your height.My screening exam showed a significant health issue.I have been in stable psychotherapy for at least 3 months.I have been on a stable dose of sleep medication for at least 4 weeks.I have been diagnosed with bipolar disorder by a psychiatrist.I am in good health based on recent medical exams and tests.I am either not able to have children or am using reliable birth control.Resides in a stable living situation, in the opinion of the investigator
Has an identified reliable informant, in the opinion of the investigator
The individual meets the diagnostic criteria for bipolar disorder (BD) as defined in the DSM-5, based on information from a psychiatrist and the MINI 7.0.2.I have a major psychiatric condition more prominent than bipolar disorder.I have been diagnosed with bipolar disorder.I am not willing to use birth control as required.I have been on stable sleep or anxiety medication for at least 4 weeks.I am currently pregnant or breastfeeding.I have taken two pregnancy tests, both negative, before starting the study treatment.Individuals who are not childbearing potential or who meet the childbearing potential criteria listed above are eligible for screening.I have been in stable psychotherapy for at least 3 months.I agree to follow the study rules and report any health changes.I am between 18 and 65 years old and can understand and sign a consent form.I am not able to have children or I am using reliable birth control.I am between 18 and 65 years old.
- Group 1: Lurasidone comparator
- Group 2: NRX-101
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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
Would I be eligible to help with this research?
"The team conducting this clinical trial is currently recruiting around 72 participants that have a manic disorder and are between 18-65 years old."
Has NRX-101 undergone the necessary testing to be approved by the FDA?
"There is both prior clinical data to support the efficacy of NRX-101 as well as multiple rounds of safety testing, so it received a score of 3."
Would you happen to know if this research is still enrolling participants?
"Presently, this study is not looking for new participants. The earliest date this information was made available was December 1st, 2019 with the most recent update on August 9th, 20212. There are 1508 other studies enrolling patients with manic disorder and 6 for NRX-101 that are actively searching for participants."
How many people are signed up to participate in this clinical trial?
"This clinical trial is not searching for patients right now, however it was last updated on 8/9/2022. If you're looking for other active studies, there are 1508 trials currently enrolling participants with manic disorder and 6 for NRX-101."
Are people of all ages being accepted for this medical study?
"Eligibility for this particular clinical trial is restricted to patients aged 18-65. There are 238 other trials that younger individuals can enroll in and 1099 for seniors."
What other similar trials exist for this medication?
"There are currently 6 different ongoing trials for NRX-101 across 46 locations in 5 countries. The first trial was completed in 2014 and, since then, 57 more have been completed. This initial study, which had 200 participants, was sponsored by Otsuka America Pharmaceutical and reached Phase 4 approval."
Is this trial popular in the United States?
"JP Smith Hospital in Fort Worth, Research Site, Houston in Houston, and Research Centers of America in Hollywood are a few of the 4 main locations running this clinical trial."
What other drugs have been studied in combination with NRX-101?
"UT Southwestern Medical Center first conducted a clinical trial on NRX-101 in 2014. Since then, there have been 57 completed trials with 6 more active ones. The majority of these ongoing studies are based in Fort Worth, Texas."
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What portion of applicants met pre-screening criteria?
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