Ketamine-assisted Psychotherapy for Depression

Overseen By Juliana Zambrano, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Massachusetts General Hospital

Disqualifiers: Psychotic disorder, Bipolar I, PTSD, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 week

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of ketamine-assisted group therapy for Spanish-speaking adults with depression. It investigates whether combining ketamine, an anesthetic, with therapy sessions can improve depression symptoms. The study is open to Latinx adults fluent in Spanish who have been diagnosed with major depressive disorder. Participants must already be seeing a psychiatrist and primary care provider. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to pioneering mental health solutions.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that ketamine-assisted psychotherapy is likely to be safe for humans?

Research has shown that ketamine is generally safe and well-tolerated for treating depression. In studies involving patients with treatment-resistant depression, ketamine proved safe. For instance, detailed research indicates that patients handle it well, with no major safety concerns reported.

Another review found that the FDA approved a type of ketamine, called esketamine, for treating severe depression. This approval suggests that ketamine is considered safe for similar conditions.

In everyday use, patients receiving ketamine did not show signs of suicidal behavior or addiction. This suggests that, even outside of strict studies, ketamine is relatively safe.

Overall, the safety information on ketamine indicates that it is well-tolerated in people with depression. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ketamine-assisted psychotherapy for depression because it offers a rapid-acting alternative to traditional antidepressants, which often take weeks to show effects. Unlike most treatments that primarily target serotonin levels, ketamine works differently by acting on the brain's glutamate system, potentially leading to faster relief from depressive symptoms. This unique mechanism may also help individuals who haven't responded well to standard therapies like SSRIs or SNRIs, offering new hope for those struggling with treatment-resistant depression.

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

Research has shown that ketamine can greatly improve depression symptoms. In one study, 52% of participants experienced a complete disappearance of severe depression symptoms after just three ketamine treatments over 11 days. Another study found clear improvement in depression, anxiety, and overall illness severity after two weeks and one month of treatment. Ketamine has also proven to be at least as effective as electroconvulsive therapy (ECT), with 55% of patients reporting their symptoms were reduced by half or more. These findings suggest ketamine has strong potential to effectively treat depression. Participants in this trial will receive ketamine in an open-label, single-arm study to further evaluate its effectiveness in treating depression. ^{6 7 8 9 10}

Who Is on the Research Team?

Juliana Zambrano, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for self-identifying Latinx, Spanish-speaking adults who have been clinically diagnosed with major depression. Participants must be under the care of an MGB psychiatrist and primary care provider to join.

Inclusion Criteria

I identify as Latinx and speak Spanish.

I have both a psychiatrist and a primary care provider at MGB.

I have been diagnosed with major depression by a doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ketamine-assisted group therapy sessions

1 week

Multiple sessions within 1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person) at 1 week, 1 visit (in-person) at 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine

Trial Overview The study is testing ketamine-assisted group therapy to see if it's safe and effective for treating depression in Spanish-speaking adults. It's a pilot trial, which means it's an early-stage study to gather initial data.

How Is the Trial Designed?

Group I: Open label Experimental Treatment 1 Intervention

Open label, single arm study

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Juliana Zambrano, MD, MPH

Lead Sponsor

Trials

1

Recruited

10+

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. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2840552

Serial Ketamine Infusions as Adjunctive Therapy to ... Secondary efficacy outcomes were change in self-rated depressive symptoms from baseline to end of treatment on the 16-item Quick Inventory ...

3. michiganmedicine.org michiganmedicine.org/health-lab/ketamines-promise-severe-depression-grows-major-questions-remain

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.

4. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/press-releases/study-finds-ketamine-effective-as-ect-for-major-depression

Study Finds Ketamine is at Least as Effective as ECT ... The researchers found that 55 percent of those receiving ketamine and 41 percent of those receiving ECT reported at least a 50 percent ...

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00304-8/fulltext

Ketamine for the treatment of major depression Higher doses reduced depressive symptoms and increased response rates at all stages in a treatment course (initial, ongoing, and lasting effects) ...

6. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-022-04268-5

Real-world depression, anxiety and safety outcomes of ... Patients receiving IM ketamine treatment had a mean of 2.8 (SD 1.4) psychiatric diagnoses. 420 (93%) patients had a diagnosis of major ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32539491/

Safety and tolerability of IV ketamine in adults with major ... Rigorous clinical trials suggest ketamine is safe and well-tolerated in patients with treatment-resistant depression (TRD).

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9010394/

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 ...

9. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2797209

Efficacy and Safety of Ketamine vs Electroconvulsive ... This systematic review and meta-analysis of 6 trials with 340 patients suggests that ECT may be superior to ketamine in improving depression severity.

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178125003397

Real World Effectiveness of Maintenance Ketamine ... Ketamine was determined to be relatively safe, with zero cases of suicidal behaviour and addiction behaviour throughout treatment. One patient ( ...