100 Participants Needed

Ketamine + Esketamine for Depression

JO
CC
Overseen ByCristina Cusin, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

The study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls. Patients will be recruited from an inpatient psychiatric unit. Eligible patients who provided informed consent will be enrolled in the study that will include a eight IV ketamine treatments, 13 esketamine treatment visits, seven long assessment visits, five short assessment visits, and daily surveys. The study will examine the feasibility, tolerability, and efficacy of repeated IV ketamine followed by esketamine, as well as predictors of treatment response.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently receiving ECT treatment or taking frequent or high doses of certain medications like benzodiazepines, opiates, or barbiturates.

Is ketamine and esketamine safe for treating depression?

Research shows that ketamine and esketamine can be safe for treating depression, with some studies reporting only temporary side effects. Long-term safety is still being studied, but they have been approved for use in treatment-resistant depression.12345

What makes the drug Ketamine + Esketamine unique for treating depression?

Ketamine and esketamine offer a rapid antidepressant effect, with subcutaneous administration being a convenient and cost-effective option, especially in developing countries. Esketamine is also available as a nasal spray for treatment-resistant depression, providing an alternative to traditional antidepressants for those who haven't responded to other treatments.34678

What data supports the effectiveness of the drug Ketamine + Esketamine for depression?

Research shows that both ketamine and esketamine can quickly and effectively reduce depression symptoms, with studies reporting significant improvement in patients, including those with treatment-resistant depression. These drugs have been found to work rapidly, often within hours, and have shown promise in reducing severe suicidal thoughts.3491011

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with Major Depressive Disorder and suicidal thoughts, who are inpatients at a psychiatric unit. They must be in good health, not pregnant or breastfeeding, willing to use birth control if applicable, have internet access and a treating psychiatrist. Excluded are those on certain CNS depressants or with recent substance abuse issues.

Inclusion Criteria

Ability to read, understand, and provide written and dated informed consent prior to screening
I have a psychiatrist who has been treating me.
Access to a mobile phone or computer with internet connection
See 5 more

Exclusion Criteria

Current diagnosis of a moderate to severe substance use disorder, within the last six months prior to screening based on DSM-5 criteria
A status of childbearing potential and is not willing to use birth control during the study
Inability to comply with study safety procedures, including having reliable escorts to and from visits
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous (IV) ketamine and intranasal (IN) esketamine treatments

24 weeks
8 IV ketamine treatments, 13 esketamine treatment visits, 7 long assessment visits, 5 short assessment visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Esketamine
  • Ketamine
Trial Overview The study tests the effects of IV ketamine followed by IN esketamine over 24 weeks against historical controls for reducing suicide risk in depression patients. It includes multiple treatment sessions, assessments visits, and daily surveys to evaluate feasibility, tolerability and predictors of response.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Ketamine and Esketamine TreatmentExperimental Treatment2 Interventions

Esketamine is already approved in United States for the following indications:

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Approved in United States as Spravato for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

American Foundation for Suicide Prevention

Collaborator

Trials
36
Recruited
10,500+

Published Research Related to This Trial

Ketamine and esketamine demonstrate rapid antidepressant effects, with improvements in clinical response observed within 40 minutes to 1 week for ketamine and 2 hours to 4 weeks for esketamine, along with reductions in depression scores and suicidality.
Despite their effectiveness, the long-term safety and efficacy of ketamine and esketamine remain uncertain, and the overall quality of the studies reviewed was critically low, highlighting the need for more rigorous research in this area.
Use of ketamine and esketamine for depression: an overview of systematic reviews with meta-analyses.Lima, TM., Visacri, MB., Aguiar, PM.[2022]
Subcutaneous (SC) administration of racemic ketamine and esketamine has shown rapid and robust antidepressant effects in both unipolar and bipolar patients, with response and remission rates ranging from 50% to 100% after single or multiple doses.
The studies indicated that SC ketamine is generally well-tolerated, with only transitory side effects, making it a promising and cost-effective treatment option for depression, especially in developing countries.
Subcutaneous Ketamine in Depression: A Systematic Review.Cavenaghi, VB., da Costa, LP., Lacerda, ALT., et al.[2021]
In a European clinical trial, a 55-year-old male with treatment-resistant depression and substance use disorder showed significant improvement in depression symptoms after a single intravenous infusion of ketamine, with reductions in Hamilton Depression Rating Scale (HDRS) scores from 36 to 16 and Beck Depression Inventory (BDI) scores from 26 to 9.
The antidepressant effects of ketamine were rapid, with the patient reporting improvements just 25 minutes into the infusion, and these effects lasted for at least 7 days, demonstrating ketamine's potential as a fast-acting treatment for depression even in patients with co-occurring substance use disorders.
Intravenous ketamine therapy in a patient with a treatment-resistant major depression.Liebrenz, M., Borgeat, A., Leisinger, R., et al.[2022]

Citations

Use of ketamine and esketamine for depression: an overview of systematic reviews with meta-analyses. [2022]
Subcutaneous Ketamine in Depression: A Systematic Review. [2021]
Intravenous ketamine therapy in a patient with a treatment-resistant major depression. [2022]
Intravenous ketamine infusion for a patient with treatment-resistant major depression: a 10-month follow-up. [2018]
Ketamine for the acute treatment of severe suicidal ideation: double blind, randomised placebo controlled trial. [2022]
The Ketamine Side Effect Tool (KSET): A comprehensive measurement-based safety tool for ketamine treatment in psychiatry. [2023]
Efficacy and safety of racemic ketamine and esketamine for depression: a systematic review and meta-analysis. [2023]
Long-term safety of ketamine and esketamine in treatment of depression. [2022]
Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression. [2022]
Repeated subcutaneous esketamine administration for depressive symptoms and pain relief in a terminally ill cancer patient: A case report. [2021]
Esketamine for treatment-resistant depression. [2021]
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