← Back to Search

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).
Timeline
Screening 14 days
Treatment 6 weeks
Follow Up 6 weeks
Awards & highlights

AFSP 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.Check my eligibility
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.See study design
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.

AFSP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old.
Select...
I have been diagnosed with major depression and currently have depression that has lasted for at least 8 weeks.
Select...
I am between 18 and 70 years old.
Select...
I have been diagnosed with major depression and have been feeling depressed for at least 8 weeks.
Select...
My condition is considered moderately resistant to treatment according to the Maudsley method.
Select...
I have been on stable sleep medication for at least 4 weeks.

AFSP Trial Timeline

Screening ~ 14 days
Treatment ~ 6 weeks
Follow Up ~6 weeks
This trial's timeline: 14 days for screening, 6 weeks for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Beck Suicidal Ideation Scale total scores will be analyzed as the measure using analysis of variance model for repeated measures.
Secondary outcome measures
The investigators will assess opioid activity of ketamine as well as buprenorphine
Other outcome measures
Pupillometry
Serum prolactin level

AFSP 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
2,379 Previous Clinical Trials
17,333,333 Total Patients Enrolled
106 Trials studying Depression
93,734 Patients Enrolled for Depression
Alan F. SchatzbergStudy DirectorStanford University

Media Library

Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04116528 — Phase 3
Depression Research Study Groups: Ketamine, Buprenorphine or Placebo
Depression Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT04116528 — Phase 3
Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04116528 — Phase 3
Depression Patient Testimony for trial: Trial Name: NCT04116528 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Stanford University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
0
3+

Why did patients apply to this trial?

Lexapro, bupoprian, aderall, TMS. Nothing works more than a little bit. Have tried more than 10.
PatientReceived 1 prior treatment
I have tried multiple drugs and none have treated my depressive symptoms sufficiently.
PatientReceived no prior treatments
Fought with depression for many years. Extreme suicide ideation at times. Currently in and out of that extreme.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How many screenings in the trial? How long can I expect to be at your facility for screening?
PatientReceived 1 prior treatment
I am HIV+ and I would like to ask and double check if I still qualify for this trial ?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Stanford University School of Medicine: < 48 hours
~13 spots leftby Mar 2025