[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06559826":3,"trial-entities:NCT06559826":111,"trial-summary:NCT06559826":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":51,"eligibility_criteria":52,"std_ages":79,"locations":82,"central_contacts":102,"overall_officials":107,"references":109,"see_also_links":110},"NCT06559826","STUDY-23-00661","Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression","A Randomized-Controlled Trial of Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression","RECRUITING","2027-08","2025-07","2025-07-15","2025-01-10","Icahn School of Medicine at Mount Sinai","OTHER",true,"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.",null,[19],"Major Depressive Disorder",[21,19,22],"Ketamine","Ketamine Assisted Psychotherapy","INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},70,"ESTIMATED",[31,37],{"type":32,"name":21,"description":33,"armGroupLabels":34},"DRUG","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.",[35,36],"Ketamine (KET)","Ketamine Assisted Psychotherapy (KAP)",{"type":38,"name":39,"description":40,"armGroupLabels":41},"BEHAVIORAL","Psychotherapy","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.",[36],[43],{"measure":44,"description":45,"timeFrame":46},"Montgomery-Asberg Depression Rating Scale (MADRS)","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.","9 weeks from baseline assessment",[],"ALL","18 Years","90 Years",false,{"inclusion":53,"exclusion":61,"raw_text":78},[54,55,56,57,58,59,60],"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",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77],"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 \\\u003C 23","Inclusion Criteria\n\n* Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study.\n* Age 18-90 years\n* Participant in good physical health\n* Participants may be on medications for depression as long as they remain on a stable dose.\n* A score of at least 20 on the 10 item Montgomery-Asberg Depression Scale at screening, corresponding to at least moderate current depression severity.\n* Meets criteria for major depressive disorder (MDD) in current major depressive episode (MDE) according to DSM-5\n* Women of child-bearing potential must have a negative pregnancy test at screening and prior to ketamine infusion\n\nExclusion Criteria\n\n* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.\n* 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.\n* Any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease and uncontrolled hypertension); endocrinologic, neurologic, immunologic, or hematologic disease\n* Clinically significant abnormalities of laboratories, physical examination, or ECG\n* Substance drug or alcohol use disorder in the prior 12 months\n* History of hypersensitivity to ketamine or esketamine\n* Lifetime history of schizophrenia, schizoaffective disorder, bipolar I or II disorder\n* Presence of psychotic symptoms in the current MDE, or lifetime psychotic disorder\n* Recreational ketamine or phencyclidine use in the last year\n* Previous non-response to clinical or research ketamine or esketamine administration\n* Concurrent treatment with ECT, TMS, or VNS in the current MDE\n* BMI \\> 35\n* Significant suicidal ideation as determined by a C-SSRS score \\>2 in past 30 days\n* History of suicide attempt or self harm in the prior 2 years\n* SBP \\> 165 or DBP \\> 95 on infusion day\n* MoCA score \\\u003C 23",[80,81],"ADULT","OLDER_ADULT",[83],{"facility":13,"status":8,"city":84,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":99},"New York","10029","United States",[88,93,96],{"name":89,"role":90,"phone":91,"email":92},"James Murrough, MD, PhD","CONTACT","212-241-6539","james.murrough@mssm.edu",{"name":94,"role":90,"phone":91,"email":95},"Rachel Fremont, MD, PhD","rachel.fremont@mssm.edu",{"name":97,"role":98},"James Murrough","PRINCIPAL_INVESTIGATOR",{"lat":100,"lon":101},40.71427,-74.00597,[103,104],{"name":94,"role":90,"phone":91,"email":95},{"name":105,"role":90,"phone":91,"email":106},"Mackenzie Brown, MPH","mackenzie.brown@mssm.edu",[108],{"name":89,"affiliation":13,"role":98},[],[],{"nct_id":4,"conditions":112,"biomarkers":114},[113],"Unipolar Depression",[],{"nct_id":4,"found":15,"summary":116,"prompt_version":126},{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is a randomized controlled trial, meaning participants will be randomly assigned to receive either ketamine-assisted psychotherapy or ketamine alone. It is a single-site study.","completed","Ketamine-Assisted Psychotherapy for Depression","This study is comparing two approaches for treating Major Depressive Disorder (MDD): ketamine-assisted psychotherapy (KAP) and ketamine alone. You could be eligible if you are an adult between 18 and 90 years old, in good physical health, and potentially already taking stable depression medication. The study aims to see if KAP is more effective than ketamine alone by measuring changes in depression severity using a scale called the Montgomery-Asberg Depression Rating Scale (MADRS) after 9 weeks. The study plans to enroll 70 participants, but its current status is unclear.","Your depression severity and other measures will be tracked for an 8-week (two-month) period after the main treatment ends.",89,"Participants will receive treatment over four weeks, which includes four to five ketamine sessions. Those in the KAP group will also have preparatory and weekly integration sessions.","Not stated in the trial record.",[21,39],"v2"]