Major Depressive Disorder
Conditions
Keywords
Ketamine, Major Depressive Disorder, Ketamine Assisted Psychotherapy
Brief summary
The proposed study is a single-site, randomized, controlled clinical trial (RCT) comparing ketamine-assisted psychotherapy (KAP) to a standard evidence-based regimen of ketamine administered in a medical model without psychotherapy (KET). Eligible study participants will be adults with major depressive disorder (MDD). Adults with MDD will be randomized to KAP or KET in a 1:1 allocation. Each treatment group will receive KAP or KET over a period of four weeks. Measurement of depression severity, wellness, neurocognitive functioning and other parameters will occur at baseline prior to treatment, immediately following the end of the acute treatment period, and over an 8-week (two month) treatment follow-up period.
Interventions
DRUGKetamine
Following screening and baseline assessments, individuals randomized to KAP will undergo a preparatory session prior to the first day of dosing. Participants will complete a sequence of four to five intramuscular (IM) ketamine assisted therapy sessions.
BEHAVIORALPsychotherapy
Each week following KAP, there will be a separate 60-minute integration session 1-6 days afterwards. Integration sessions will focus on processing experiences and material that emerged in KAP sessions (such as assimilating challenging experiences, making meaning of experiences and imagery, working through memories and emotions, and exploring emerging relational patterns) as well as strengthening insights. Within one week of the completion of all KAP sessions, there will be one additional integration session focused on consolidating the insights and improvements gained from KAP treatment.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | 9 weeks from baseline assessment | MADRS: The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points, with higher scores indicating more severe depressive symptoms. |
Countries
United States
Contacts
Primary ContactRachel Fremont, MD, PhD
Backup ContactMackenzie Brown, MPH
Outcome results
None listed