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NMDA Receptor Antagonist
Ketamine + Buprenorphine for Depression (AFSP Trial)
Phase 3
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female, 18 to 70 years of age, inclusive, at screen.
Diagnosed with Major Depressive Disorder (MDD), single or recurrent, and currently experiencing a Major Depressive Episode (MDE) of at least eight weeks in duration, prior to screening, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(DSM-IV-TR™). The diagnosis of MDD will be made by a site psychiatrist and supported by the Structured Clinical Interview for DSM-IV-TR™ (SCID-I/P).
Must not have
Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
Female that is pregnant or breastfeeding.
Timeline
Screening 14 days
Treatment 6 weeks
Follow Up 6 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
Summary
This trial will test whether ketamine followed by buprenorphine is more effective than ketamine followed by placebo in reducing suicidal thoughts.
Who is the study for?
Adults aged 18-70 with Major Depressive Disorder currently in a depressive episode of at least 8 weeks, who haven't responded well to two different antidepressants for this episode. They must be generally healthy and women must use effective birth control or be non-childbearing. People with certain physical conditions, drug abuse history, or other mental health disorders are excluded.
What is being tested?
The study is testing if ketamine followed by buprenorphine is more effective than ketamine followed by a placebo in reducing suicidal thoughts quickly and for an extended period. Participants will receive intravenous infusions over approximately 2.5 years.
What are the potential side effects?
Ketamine may cause disorientation, dizziness, nausea, increased blood pressure and heart rate changes shortly after administration. Buprenorphine can lead to symptoms like constipation, headache, nausea, sleepiness and potential dependency.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
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I have been diagnosed with major depression and currently have depression that has lasted for at least 8 weeks.
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I am between 18 and 70 years old.
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I have been diagnosed with major depression and have been feeling depressed for at least 8 weeks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not willing to use specified birth control methods during the study.
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I am currently pregnant or breastfeeding.
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I am not pregnant, as confirmed by a test.
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I have a history of schizophrenia, schizoaffective disorders, or psychosis during depression.
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I have a long-term lung condition.
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I have never had brain surgery, serious brain infections, major brain disorders, or significant head trauma in the last 2 years.
Timeline
Screening ~ 14 days1 visit
Treatment ~ 6 weeks8 visits
Follow Up ~ 6 weeks7 visits
Screening ~ 14 days
Treatment ~ 6 weeks
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Beck Suicidal Ideation Scale total scores will be analyzed as the measure using analysis of variance model for repeated measures.
Secondary study objectives
The investigators will assess opioid activity of ketamine as well as buprenorphine
Other study objectives
Pupillometry
Serum prolactin level
Awards & Highlights
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.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: KetamineExperimental Treatment1 Intervention
Every eligible participant will receive 0.5mg/kg IV given over 40 minutes
Group II: Buprenorphine or PlaceboActive Control2 Interventions
Buprenorphine or placebo once daily for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,474 Previous Clinical Trials
17,501,880 Total Patients Enrolled
109 Trials studying Depression
93,866 Patients Enrolled for Depression
Alan F. SchatzbergStudy DirectorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine
- Group 2: Buprenorphine or Placebo
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
Depression Patient Testimony for trial: Trial Name: NCT04116528 — Phase 3
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