10 Participants NeededMy employer runs this trial

Ketamine for Depression

HB
JR
Overseen ByJennifer R Goldschmied, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how ketamine, a medication, can assist individuals with Major Depressive Disorder (MDD) by examining changes in brain activity. Researchers believe ketamine may strengthen brain connections and use a special imaging technique to observe these changes. The goal is to determine if these brain changes can lead to better and longer-lasting mood improvements. The trial seeks participants whose depression has not responded to at least two other treatments. As an Early Phase 1 trial, this research aims to understand how ketamine works in people, offering participants an opportunity to contribute to groundbreaking insights into depression treatment.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that ketamine can be effective and generally well-tolerated for treating depression. Studies have found that ketamine, especially when administered intravenously, can quickly reduce symptoms of depression and even thoughts of suicide. Some individuals experience improvement after just a few treatments.

Regarding safety, the FDA (Food and Drug Administration) has approved ketamine for certain types of depression, indicating its safety for those conditions. However, like any treatment, it can have side effects. Common side effects include temporary feelings of disconnection from reality, high blood pressure, and drowsiness.

Overall, ketamine has shown promise for treating depression safely, but individual experiences may vary. It is always important to discuss potential risks and benefits with a healthcare provider.12345

Why do researchers think this study treatment might be promising for depression?

Unlike the standard treatments for Major Depressive Disorder, such as SSRIs or SNRIs that often take weeks to show effects, ketamine has the potential to provide rapid relief from depressive symptoms, sometimes within hours. Ketamine works uniquely by targeting the NMDA receptors in the brain, which is a different mechanism of action compared to traditional antidepressants that primarily affect serotonin levels. Researchers are excited about ketamine because of its fast-acting properties and its potential to help patients who have not responded well to other medications.

What evidence suggests that ketamine might be an effective treatment for depression?

Research has shown that ketamine can quickly alleviate depression. In one study, over half of the participants experienced a significant decrease in depression symptoms within 24 hours. Another study found that 55% of people had lasting improvement in their symptoms after ketamine treatment. After just three treatments, 52% of participants saw their severe depression symptoms ease significantly, reaching remission. This trial will further investigate ketamine's effectiveness for rapidly treating major depression, although its long-term effects remain under study.678910

Who Is on the Research Team?

JR

Jennifer R Goldschmied, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

Inclusion Criteria

Ability to provide informed consent
Current depression as assessed on the SCID
Able to comprehend English, as all questionnaires are in this language
See 3 more

Exclusion Criteria

History of bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia, and other psychotic disorders as assessed on the SCID
Alcohol or drug abuse in the past year based upon the SCID or urine toxicology screen
Current smoker
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 virtual visit

At-home Sleep Recording

Participants complete a 7-day at-home sleep diary to assess sleep patterns prior to ketamine infusion

1 week

Treatment

Participants undergo baseline MRI, mood assessments, and receive a 40-minute ketamine infusion followed by post-infusion assessments

1 day
1 in-person visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Ketamine

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Major Depressive DisorderExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Citations

Efficacy of ketamine therapy in the treatment of depression

Ketamine has a robust and rapid effect on depression, which was seen immediately after the administration of ketamine and sustained at the end of 1 month.

Ketamine's promise for severe depression grows, but major ...

After just three infusions of ketamine over 11 days, 52% of participants saw their severe depression ease so much they achieved remission.

Ketamine versus ECT for Nonpsychotic Treatment ...

These trials showed that remission with ketamine was inferior to that with ECT. Our trial differs from these reports in that it included only ...

Ketamine found effective in treatment-resistant depression

55 percent of those who received ketamine treatment experienced a sustained improvement in depressive symptoms without major side effects.

The effects of ketamine and esketamine on functional ...

Conclusion. Esketamine alleviates depressive symptoms and improves functioning, notably in workplace domains. Future studies should include functional outcomes ...

Ketamine treatment for depression: a review - PMC

The FDA approved intranasally-administered esketamine for treatment-resistant depression (TRD) in adults in 2019 and for the treatment of major depressive ...

IV Ketamine Shows Rapid Benefits for Suicide Risk ...

A meta-analysis of 26 trials found that IV ketamine rapidly reduced suicidal and depressive symptoms in patients with major depressive episodes.

First study to compare ketamine therapies for patients with ...

Both groups showed significant overall decreases in depression severity after the final treatment compared to pretreatment baseline. IV ketamine ...

Ketamine for Depression in Serious Illness: Evidence, Safety ...

Though data are less robust in the serious illness context, ketamine appears to be safe among individuals with comorbid serious illnesses (particularly cancer) ...

Comparative safety and tolerability of ketamine ...

Ketamine and esketamine have demonstrated rapid, short-term antidepressant effects in major depressive disorder (MDD), but their relative safety ...