Ketamine for Depression

Overseen By Elizabeth A Bartlett, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: New York State Psychiatric Institute

Must not be taking: Antidepressants, Benzodiazepines, NSAIDs, others

Disqualifiers: Schizophrenia, Bipolar, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how ketamine reduces suicidal thoughts in people with major depressive disorder by affecting stress-related brain systems. Researchers will use smartphone tracking and PET scans to observe patient responses to stress and ketamine's influence on brain pathways. Ideal participants have a diagnosis of major depressive disorder and no history of ketamine-related issues, such as abuse or side effects. As a Phase 4 trial, this research explores how an FDA-approved and effective treatment can benefit more patients.

Do I need to stop taking my current medications to join the trial?

Yes, you will need to stop taking certain medications to join the trial. Specifically, you must not use antidepressants within 14 days, benzodiazepines within 1 day, fluoxetine or other long-acting antidepressants within 6 weeks, and any medications that affect brain biology of interest within 1 month before participating.

What is the safety track record for this treatment?

Research has shown that ketamine appears safe for treating depression. Some studies have found that repeated doses of ketamine are safe for individuals with major depressive disorder (MDD) that hasn't responded to other treatments. Additional research supports that ketamine does not impair cognitive abilities.

However, ketamine is not specifically approved by the FDA for any mental health condition, indicating that more research is needed to confirm its safety and effectiveness. Despite this, ketamine infusions have quickly and effectively reduced depression symptoms for many individuals.

Overall, previous patients have tolerated ketamine well, with few serious side effects. Prospective trial participants should consult a healthcare provider to understand the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about ketamine for treating depression because it offers a rapid onset of relief compared to traditional antidepressants like SSRIs or SNRIs, which can take weeks to become effective. Ketamine works differently by targeting the NMDA receptors in the brain, which is a new mechanism of action compared to the usual focus on serotonin or norepinephrine pathways. This unique approach has the potential to provide quick and effective relief for those who haven't responded well to conventional treatments.

What is the effectiveness track record for ketamine in treating depression?

Research has shown that ketamine, the treatment under study in this trial, can effectively treat depression. Studies have found that patients often feel much better within 72 hours after receiving a ketamine infusion compared to those who received a placebo. Another study discovered that ketamine can help with depression, anxiety, and overall illness severity as soon as two weeks after treatment. The effects of ketamine on depression can be felt quickly, sometimes within just four hours, with the most significant benefits seen at 24 hours. For people with depression that hasn't improved with other treatments, ketamine provided fast relief in 64% of cases. Overall, ketamine is a strong option for managing depression symptoms. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with major depressive disorder who may have suicidal thoughts. Participants must use birth control if applicable and cannot have a history of head injury, aggressive behavior, uncontrolled hypertension, certain medical conditions or MRI contraindications. They should not be using specific medications that affect brain biology.

Inclusion Criteria

I have been diagnosed with major depression.

Persons of child-bearing potential must agree to use an acceptable method of birth control throughout the study.

Exclusion Criteria

Previous head injury with evidence of cognitive impairment. Subjects who endorse a history of prior head trauma and score 1.5 standard deviations below the mean on Trail-making A or B will be excluded from study participation

Aggressive behavior that is a significant threat to others such as physically assaultive behavior (in the last month)

Any condition or material in the body that is a contraindication for MRI procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single infusion of racemic ketamine hydrochloride 0.5 mg/kg

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including smartphone tracking and PET brain scans

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine

Trial Overview The study tests how ketamine hydrochloride infusion affects stress-related brain pathways in individuals with depression. It involves smartphone tracking for real-time stress responses and PET scans to observe the impact on the brain.

How Is the Trial Designed?

Group I: Ketamine Experimental Treatment 1 Intervention

single racemic ketamine hydrochloride 0.5 mg/kg infusion

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

American Foundation for Suicide Prevention

Collaborator

Trials

36

Recruited

10,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6767816/

Efficacy of ketamine therapy in the treatment of depression Results: There was a significant improvement in depression, anxiety, and the severity of illness after 2 weeks and 1 month of the last dose of ketamine.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165032725019081

Oral ketamine for the treatment of major depressive and ... Oral ketamine is safe and shows promising efficacy in treating depression. •. Meta-analysis estimated a number needed to treat of 5 for ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10686270/

Antidepressant effects of ketamine in depressed patients Subjects with depression evidenced significant improvement in depressive symptoms within 72 hours after ketamine but not placebo infusion.

4. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2013.13030392

Antidepressant Efficacy of Ketamine in Treatment-Resistant ... Intravenous ketamine demonstrated rapid antidepressant effects in an optimized study design, improving depression severity in 64% of treatment-resistant ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2021.710338/full

An Integrative Approach to Ketamine Therapy May ... Results indicated that ketamine had an effect on depressive symptoms within 4 h following a single infusion, with peak efficacy at 24 h.

6. fda.gov fda.gov/drugs/human-drug-compounding/fda-warns-patients-and-health-care-providers-about-potential-risks-associated-compounded-ketamine

FDA warns about compounded ketamine for psychiatric ... Ketamine is not FDA approved for the treatment of any psychiatric disorder, and additional clinical studies are needed to adequately investigate ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0165032724003616

Cognitive outcomes from the randomised, active-controlled ... The findings support the cognitive safety of repeated fixed and escalating doses at least in the short-term in people with treatment resistant MDD.

8. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.992624/full

Safety, effectiveness and tolerability of sublingual ketamine ... This study demonstrates that SL ketamine is a novel, safe, and effective treatment for TRD and treatment-resistant anxiety.

9. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2018.18070834

Single, Repeated, and Maintenance Ketamine Infusions for ... Repeated ketamine infusions have cumulative and sustained antidepressant effects. Reductions in depressive symptoms were maintained among responders through ...