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Ketamine + Buprenorphine for Depression (AFSP Trial)
AFSP Trial Summary
This trial will test whether ketamine followed by buprenorphine is more effective than ketamine followed by placebo in reducing suicidal thoughts.
AFSP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAFSP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AFSP Trial Design
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Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
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- You meet the threshold on the total SSI score of >/=11 at both screening and baseline visits.You have a condition that affects your memory or thinking, such as dementia or delirium.I am either not able to have children or am using effective birth control.You have had an eating disorder such as anorexia, bulimia, or other similar disorders within the past five years.You cannot participate in this study if you have taken part in another research study that involves a new drug or device in the past month or at the same time as this study.I have never had brain surgery, serious brain infections, major brain disorders, or significant head trauma in the last 2 years.You are currently taking or have been taking opioid medications for a long time.Your body mass index (BMI), which is a measure of your body fat based on your weight and height, should be between 17 and 35.My condition is considered moderately resistant to treatment according to the Maudsley method.You are not pregnant, are not using hormonal birth control, are not on hormone replacement therapy, are not in a monogamous relationship with a partner who has had a vasectomy, or are sexually abstinent.I have depression that didn't improve after trying two different treatments.I am not willing to use specified birth control methods during the study.I have a history of schizophrenia, schizoaffective disorders, or psychosis during depression.The investigator thinks you might be at risk of hurting yourself while participating in the study.I have been diagnosed with major depression and have been feeling depressed for at least 8 weeks.I have been diagnosed with a stable mental health condition like anxiety or phobia.I am in good health overall, confirmed by recent medical exams and tests.I agree to use effective birth control or remain abstinent during the study.I have been diagnosed with major depression and currently have depression that has lasted for at least 8 weeks.I have been on a stable thyroid medication dose for 6 months or more.I have depression that didn't improve after trying two different treatments.I have been in stable psychotherapy for at least 3 months and will continue it during the study.I am between 18 and 70 years old.I have been on stable sleep medication for at least 4 weeks.I have a health issue that could affect my safety or the study results.I am currently pregnant or breastfeeding.I have a long-term lung condition.You do not have any mental health disorders that are more severe than your depression, and you have not had any mental health issues that were more severe than your depression within the past six months. However, if you have borderline personality disorder, you cannot participate.I am between 18 and 70 years old.I am not pregnant, as confirmed by a test.I was treated for an overactive thyroid less than 6 months ago.You have a medical condition that could be risky or make it difficult to interpret the study results, according to the investigator's opinion.
- Group 1: Ketamine
- Group 2: Buprenorphine or Placebo
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 14 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Weeks after you stop receiving the treatment.
Frequently Asked Questions
How can I get involved in this clinical trial?
"This study is looking for 60 participants, all of whom must meet the following criteria: - Aged 18-70 - Male or female - Has a history of treatment resistant depression (TRD) during the current major depressive episode (MDE), as assessed by the investigator. TRD is defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms), as perceived by the participant, to at least two "treatment courses" of a therapeutic dose of an antidepressant therapy of at least 8 weeks duration. The adequacy of dose and duration of the antidepressant therapy"
Does the FDA greenlight this therapy?
"This trial is classified as a Phase 3, so there is some evidence of the treatment's efficacy and multiple rounds of data which support its safety. Consequently, our team at Power has given it a score of 3 for safety."
Could you tell me the status of recruitment for this research project?
"Yes, that is accurate. The clinicaltrials.gov website contains information revealing that this study is looking for 60 patients from 1 site. This trial was posted on August 1st 2020 and updated November 2nd 2022."
Are elderly people able to participate in this clinical trial?
"Eligibility requirements for this study state that participants must be between 18-70 years old."
What are some conditions that this therapy is used to manage?
"The treatment being studied is effective for managing pain, general anesthesia, and the induction and maintenance of general anesthesia."
How many people are being asked to participate in this test?
"That is correct, the latest information from clinicaltrials.gov suggests that this study is still recruiting patients. This research project was originally posted on August 1st 2020 and updated as recently as November 2nd 2022. The goal is to have 60 people participating at one site."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Typically responds via
Average response time
- < 2 Days
Most responsive sites:
- Stanford University School of Medicine: < 48 hours
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