Comparing ketamine-assisted psychotherapy to ketamine alone for treating depression
A Randomized-Controlled Trial of Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression
PHASE2 · Icahn School of Medicine at Mount Sinai · NCT06559826
This study is testing whether combining ketamine with therapy can help adults with depression feel better compared to just using ketamine alone.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06559826 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled trial that aims to compare the effectiveness of ketamine-assisted psychotherapy (KAP) with standard ketamine treatment without psychotherapy (KET) in adults suffering from major depressive disorder (MDD). Participants will be randomly assigned to either KAP or KET and will undergo treatment over a four-week period. The study will assess various outcomes, including depression severity and neurocognitive functioning, at baseline, immediately after treatment, and during an eight-week follow-up. The goal is to determine if the addition of psychotherapy enhances the therapeutic effects of ketamine.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-90 who are diagnosed with major depressive disorder and are in good physical health.
Not a fit: Patients who are pregnant, breastfeeding, or have unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with major depressive disorder by combining psychotherapy with ketamine.
How similar studies have performed: Other studies have shown promising results with ketamine-assisted psychotherapy, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study. * Age 18-90 years * Participant in good physical health * Participants may be on medications for depression as long as they remain on a stable dose. * A score of at least 20 on the 10 item Montgomery-Asberg Depression Scale at screening, corresponding to at least moderate current depression severity. * Meets criteria for major depressive disorder (MDD) in current major depressive episode (MDE) according to DSM-5 * Women of child-bearing potential must have a negative pregnancy test at screening and prior to ketamine infusion Exclusion Criteria * Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. * Any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease and uncontrolled hypertension); endocrinologic, neurologic, immunologic, or hematologic disease * Clinically significant abnormalities of laboratories, physical examination, or ECG * Substance drug or alcohol use disorder in the prior 12 months * History of hypersensitivity to ketamine or esketamine * Lifetime history of schizophrenia, schizoaffective disorder, bipolar I or II disorder * Presence of psychotic symptoms in the current MDE, or lifetime psychotic disorder * Recreational ketamine or phencyclidine use in the last year * Previous non-response to clinical or research ketamine or esketamine administration * Concurrent treatment with ECT, TMS, or VNS in the current MDE * BMI \> 35 * Significant suicidal ideation as determined by a C-SSRS score \>2 in past 30 days * History of suicide attempt or self harm in the prior 2 years * SBP \> 165 or DBP \> 95 on infusion day * MoCA score \< 23
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: James Murrough, MD, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Rachel Fremont, MD, PhD
- Email: rachel.fremont@mssm.edu
- Phone: 212-241-6539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Disorder, Ketamine, Ketamine Assisted Psychotherapy