Ketamine for Mental Illness

Overseen By Arjay Cordero

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Stanford University

Disqualifiers: Psychotic disorder, Pregnant, Ketamine use, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to understand how ketamine brings about dissociative symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug Ketamine Hydrochloride for mental illness?

Research shows that ketamine hydrochloride can quickly and effectively reduce symptoms in people with mood and anxiety disorders that haven't improved with other treatments. It has also shown promise in treating depression, bipolar disorder, PTSD, and reducing suicidal thoughts, although more long-term studies are needed to fully understand its effects. ^{1 2 3 4 5}

Is ketamine safe for use in treating mental illness?

Ketamine is generally considered safe when used as a treatment for mental disorders, with no reported cases of overdose or death in therapeutic settings. However, some adverse events like apnea (temporary stopping of breathing) have been noted, so careful monitoring is recommended during treatment. ^{1 6 7 8 9}

How is the drug ketamine unique in treating mental illness?

Ketamine is unique because it can produce rapid and strong antidepressant effects in patients whose mood and anxiety disorders have not responded to other treatments. Unlike traditional antidepressants, ketamine works quickly, often within hours, and is administered as an injection, which is different from the typical oral medications. ^{1 3 9 10 11}

Research Team

Karl Deisseroth, MD, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults over 18 who are inpatients at Stanford Medical Center's clinical neuro units. Women must use effective birth control during the study, including hormonal methods, barrier methods with spermicide, IUDs, or abstinence.

Inclusion Criteria

I am older than 18 years.

I am using or will use effective birth control during the study.

You are an inpatient at Stanford Medical Center's clinical neuro units.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

1 day

1 visit (in-person)

Follow-up

Participants are monitored for dissociative symptoms and other effects of ketamine

1 week

Treatment Details

Interventions

• Ketamine Hydrochloride

Trial Overview The study aims to understand how ketamine hydrochloride affects brain function related to dissociative symptoms often seen in mental illness and disruptive behaviors.

Participant Groups

Group I: Ketamine Experimental Treatment 1 Intervention

Study participants will receive 0.5mg/kg of ketamine - one single infusion

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Ketamine hydrochloride has shown rapid and significant antidepressant effects in patients with treatment-resistant mood and anxiety disorders, although the studies supporting this have small sample sizes and limited long-term data.

While ketamine may offer benefits for some patients, there are important safety concerns and limitations in the existing research that must be considered when using it as an off-label treatment for psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Consensus Statement on the Use of Ketamine in the Treatment of Mood Disorders. Sanacora, G., Frye, MA., McDonald, W., et al.[2022]

In a study of 85 patients with treatment-resistant depression receiving intravenous ketamine, only 18.3% responded positively during the initial treatment phase, but nearly half of the patients chose to continue with maintenance therapy, indicating perceived benefits despite low response rates.

The study found that 32.9% of patients continued on maintenance ketamine, suggesting that even with limited efficacy, many patients felt significant improvement in their symptoms, highlighting the potential for ketamine as a treatment option for those with difficult-to-treat depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome in outpatients with depression treated with acute and maintenance intravenous ketamine: A retrospective chart review. Sakurai, H., Jain, F., Foster, S., et al.[2021]

Ketamine has shown potential benefits in treating psychiatric conditions like major depression and in supporting abstinence from alcohol and opiates, based on a literature review of studies from 2003 to 2013.

Despite its promising therapeutic effects, ketamine poses a risk of abuse and dependence, leading to various somatic, psychiatric, and cognitive complications, highlighting the need for careful consideration in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ketamine: psychiatric indications and misuses]. Delimbeuf, N., Petit, A., Karila, L., et al.[2015]

Ketamine has shown significant promise as a rapidly acting antidepressant for treatment-resistant major depressive disorder (MDD), with potential efficacy also noted in bipolar depression and post-traumatic stress disorder.

While most side effects of ketamine, such as neuropsychiatric and cardiovascular disturbances, are short-lived, the long-term safety profile remains uncertain, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine for treatment-resistant depression: recent developments and clinical applications. Schwartz, J., Murrough, JW., Iosifescu, DV.[2019]

Low-dose ketamine infusion has shown rapid effects in reducing suicidal thoughts, making it a potentially valuable treatment in general hospital settings for patients at risk of suicide.

The treatment was reported to be efficient and well-tolerated in a patient who had recently attempted suicide, suggesting a favorable benefit-risk ratio for its use in acute care situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine Use for Suicidal Ideation in the General Hospital: Case Report and Short Review. Vulser, H., Vulser, C., Rieutord, M., et al.[2022]

In a systematic review of 93 studies involving 3756 participants receiving sub-anesthetic doses of ketamine for psychiatric disorders, only four serious adverse medical events (MSAEs) were reported, resulting in an incidence of approximately 0.1%, indicating a very low risk of serious complications.

No serious cardiac events or deaths were observed, and most studies effectively screened out high-risk patients, suggesting that with proper medical screening, ketamine can be administered safely for psychiatric treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the incidence of medical serious adverse events in sub-anesthetic ketamine treatment of psychiatric disorders. Hovda, N., Gerrish, W., Frizzell, W., et al.[2023]

Ketamine shows promise as a treatment for treatment-resistant depression (TRD), but its use can lead to common adverse events, which are usually temporary.

A case of apnea during a slow sub-anesthetic infusion of ketamine highlights a rare but serious potential side effect, emphasizing the need for careful monitoring and management during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apnea during slow sub-anaesthetic infusion of intravenous ketamine for treatment-resistant depression. Gómez-Revuelta, M., Fernández-Rodríguez, M., Boada-Antón, L., et al.[2021]

A review of 34 articles revealed 312 cases of overdose and 138 deaths related to ketamine use, primarily in recreational settings and often involving polydrug use, highlighting significant risks associated with misuse.

Despite concerns about ketamine's safety in non-medical contexts, no overdoses or deaths were reported from its use as an antidepressant in therapeutic settings, suggesting it can be safely prescribed when used appropriately.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overdoses and deaths related to the use of ketamine and its analogues: a systematic review. Chaves, TV., Wilffert, B., Sanchez, ZM.[2023]

Ketamine hydrochloride (50mg/ml) remains chemically stable for up to 180 days when stored in polypropylene syringes at room temperature, making it suitable for advance preparation.

The study confirmed that the concentration of ketamine does not fall below 90% of its initial value during this period, ensuring its efficacy for use as an anesthetic agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term stability of ketamine hydrochloride 50mg/ml injection in 3ml syringes. Huvelle, S., Godet, M., Hecq, JD., et al.[2022]

A meta-analysis of 36 studies involving 725 healthy volunteers found that acute administration of ketamine significantly increases transient schizophrenia-like symptoms, with a large effect size for both total (SMD = 1.50) and positive symptoms (SMD = 1.55) compared to placebo.

The study suggests that using a bolus followed by a constant infusion of ketamine is associated with a greater increase in positive symptoms, indicating that bolus doses should be avoided in therapeutic settings to reduce the risk of inducing psychotic symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Ketamine With Psychiatric Symptoms and Implications for Its Therapeutic Use and for Understanding Schizophrenia: A Systematic Review and Meta-analysis. Beck, K., Hindley, G., Borgan, F., et al.[2021]

A case series of 9 daily ketamine users revealed severe urinary symptoms, including dysuria and hematuria, linked to chronic ketamine use, with all patients diagnosed with severe ulcerative cystitis.

Investigations showed bladder wall thickening and inflammation, and cessation of ketamine use along with treatment provided some relief, highlighting the potential for serious bladder issues associated with recreational ketamine use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine-associated ulcerative cystitis: a new clinical entity. Shahani, R., Streutker, C., Dickson, B., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Consensus Statement on the Use of Ketamine in the Treatment of Mood Disorders. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term outcome in outpatients with depression treated with acute and maintenance intravenous ketamine: A retrospective chart review. [2021]

3. Belgium pubmed.ncbi.nlm.nih.gov

[Ketamine: psychiatric indications and misuses]. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Ketamine for treatment-resistant depression: recent developments and clinical applications. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Ketamine Use for Suicidal Ideation in the General Hospital: Case Report and Short Review. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review of the incidence of medical serious adverse events in sub-anesthetic ketamine treatment of psychiatric disorders. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Apnea during slow sub-anaesthetic infusion of intravenous ketamine for treatment-resistant depression. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Overdoses and deaths related to the use of ketamine and its analogues: a systematic review. [2023]

9. France pubmed.ncbi.nlm.nih.gov

Long-term stability of ketamine hydrochloride 50mg/ml injection in 3ml syringes. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Association of Ketamine With Psychiatric Symptoms and Implications for Its Therapeutic Use and for Understanding Schizophrenia: A Systematic Review and Meta-analysis. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Ketamine-associated ulcerative cystitis: a new clinical entity. [2022]