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NMDA Receptor Antagonist
Low-Dose IV Ketamine for Adolescent Depression
Phase < 1
Recruiting
Research Sponsored by Rady Children's Hospital, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour, 3 hours, 1 day, 3 days, 7 days after treatment
Awards & highlights
Study Summary
This trial will test if a low dose of ketamine given to teens with resistant depression and suicidal thoughts can reduce those symptoms better than placebo.
Who is the study for?
This trial is for adolescents with treatment-resistant depression and suicidal thoughts who need psychiatric admission but no further medical treatment. They must have tried at least two antidepressants without success, and a parent or guardian must consent. Those pregnant, breastfeeding, on certain medications like lamotrigine, or with conditions like psychosis or substance abuse disorder can't join.Check my eligibility
What is being tested?
The study tests if a single low-dose of IV ketamine helps reduce symptoms of depression and suicidal ideation in the emergency department compared to saline (placebo). Participants' depression levels are measured several times from one hour up to seven days after treatment.See study design
What are the potential side effects?
Ketamine may cause side effects such as changes in blood pressure, disorientation, altered perception, nausea, vomiting, dizziness, sedation or euphoria. Long-term effects are not being studied here.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 hour, 3 hours, 1 day, 3 days, 7 days after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour, 3 hours, 1 day, 3 days, 7 days after treatment
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 Depression Inventory Depression sub-scale Score
Secondary outcome measures
Change in Beck Depression Inventory anxiety sub-scale score
Change in Beck Depression Inventory self-concept sub-scale score
Change in Suicidal Ideation Questionnaire score
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
This group will be given ketamine 0.2mg/kg
Group II: PlaceboPlacebo Group1 Intervention
This group will be given normal saline in matched syringe
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
Find a Location
Who is running the clinical trial?
Rady Children's Hospital, San DiegoLead Sponsor
38 Previous Clinical Trials
13,476 Total Patients Enrolled
University of California, San DiegoOTHER
1,120 Previous Clinical Trials
1,521,605 Total Patients Enrolled
29 Trials studying Depression
56,148 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with a primary psychotic disorder (such as schizophrenia), autism spectrum disorder, developmental delay or intellectual disability, or substance abuse disorder within the past 6 months.You have changes in your mental abilities or behavior.You have a history of violent behavior or thoughts of hurting others.You cannot participate if you have had a bad or allergic reaction to ketamine in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Treatment
Awards:
This trial has 2 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical trial extend to individuals beyond the age of thirty?
"This clinical trial necessitates that applicants between the ages of 12 and 18 take part. There are 247 trials for minors, while 1155 studies invite seniors to participate."
Answered by AI
How many people are enrolling in this clinical endeavor?
"Yes, according to the information on clinicaltrials.gov, this research trial is currently recruiting patients. It was initially posted on March 1st 2022 and last modified on March 7th of the same year. This study requires 30 participants across a single site."
Answered by AI
Are there still vacancies in this trial for participants?
"Affirmative. Per the details provided on clinicaltrials.gov, this medical experiment is presently recruiting patients - it was published to the platform on March 1st 2022 and its most recent update occurred July 3rd of that same year. 30 individuals are needed in total at one research centre."
Answered by AI
For whom is this research project open to participation?
"This trial is currently welcoming 30 minors aged 12 to 18 with suicidal thoughts. Additionally, the participants must have undergone psychiatric evaluation and been diagnosed as needing inpatient treatment for their depression, which has not responded to two prior courses of antidepressants each lasting a minimum of 4 weeks; lastly, parental/guardian consent needs to be obtained (in person or by phone)."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
Colorado
New Mexico
Other
How old are they?
< 18
18 - 65
What site did they apply to?
Rady Children's Hospital San Diego
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I am Sarah Thompson, mother of Grace Thompson. My daughter has been on three different medications successfully to treat her major depressive disorder, invasive thoughts, suicidal ideations and anxiety without success.
My daughter and I escaped domestic abuse in 2017 and have not been able to fully recover from our experience. I personally have been undergoing ketamine treatments with great success. My doctor administering the treatments, Dr. Eric Tepper suggested that I look into clinical trials for ketamine for adolescents for Grace as he believes her to be a good candidate.
Thank you for considering my daughter for this clinical trial. I hope she will be selected.
Kindly,
Sarah Thompson
916-202-7080.
PatientReceived 2+ prior treatments
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