Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Aug 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to treat Major Depressive Disorder (MDD) using ketamine, a medication known for its rapid antidepressant effects. One group of participants will receive ketamine along with psychotherapy, which is a type of talk therapy designed to help with mental health issues. The other group will receive ketamine alone, without psychotherapy. The goal is to see which method is more effective in improving depression symptoms. This study is open to adults aged 18 to 90 who are experiencing moderate to severe depression and are in good physical health.

Participants in this trial can expect to undergo treatment for four weeks, during which their depression severity, overall wellness, and cognitive functioning will be measured at different points. To be eligible, participants must be willing to provide consent, have a certain level of depression severity, and can be on stable medications for depression. However, individuals with certain medical conditions, pregnant or breastfeeding women, and those with a history of severe mental health issues may not qualify. This study is currently recruiting participants, and it aims to provide valuable insights into how ketamine can be used more effectively in treating depression.

Gender

ALL

Eligibility 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