[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06164756":3,"trial-entities:NCT06164756":94,"trial-summary:NCT06164756":98},{"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":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":45,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":15,"eligibility_criteria":70,"std_ages":74,"locations":77,"central_contacts":87,"overall_officials":88,"references":92,"see_also_links":93},"NCT06164756","2000036071","Long Term Follow Up KET-PD","Long-Term Follow-Up for Subjects Enrolled in the Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD) Trial","ENROLLING_BY_INVITATION","2025-12-21","2025-07","2025-07-11","2023-10-18","Yale University","OTHER",false,"The purpose of this study is to examine a) the longer-term effects of ketamine for treating depression in Parkinson's disease (PD) and b) the effects of CBT on maintaining the effects of ketamine.","This is a roll-out study from the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394). We will adopt an implementation science approach to have participants across ketamine and placebo groups in one of two arms: a) follow-up with treatment as usual (TAU) (at 3 and 6 months post-infusions); b) follow-up with 3 months of Cognitive Behavior Therapy (CBT) post-infusions, delivered remotely once per week, with follow-up assessments at 3 and 6 month timepoints. CBT is expected to have a superior sustained antidepressant response to the TAU follow-up group in both ketamine and placebo arms. We hypothesize that ketamine + CBT will show the most superior antidepressant response at follow-up.",[19,20],"Parkinson's Disease","Depression",[22],"Long Term Effect Ketamine Treatment","OBSERVATIONAL",null,[],{"count":27,"type":28},40,"ESTIMATED",[30,36],{"type":14,"name":31,"description":32,"armGroupLabels":33},"Cognitive Behavior Therapy (CBT)","Participants will receive 10 weeks of CBT",[34,35],"Experimental: Ketamine Infusion","Placebo Comparator: Saline Infusion",{"type":14,"name":37,"description":38,"armGroupLabels":39},"Treatment As Usual (TAU)","Participants will receive standard of care treatment",[34,35],[41],{"measure":42,"description":43,"timeFrame":44},"Long-Term Change in Depression Severity","Change in MADRS score following course of ketamine vs. placebo treatment at 3 and 6 month timepoints; and change in MADRS across treatment (ketamine\u002Fplacebo) and follow-up (CBT\u002FTAU) arms at 3 and 6 month timepoints. The scale used to measure depression severity is called The Montgomery-Åsberg Depression Rating Scale (MADRS). The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. The overall score ranges from 0 to 60, higher MADRS score indicates more severe depression.","3 Months and 6 Months",[46,49,52,55,58,61,64],{"measure":47,"description":48,"timeFrame":44},"Change in Apathy","Changes in apathy determined by the Starkstein Apathy Scale (SAS) scale",{"measure":50,"description":51,"timeFrame":44},"Change in Anxiety","Changes in anxiety determined by the State-Trait Anxiety Inventory (STAI) scale",{"measure":53,"description":54,"timeFrame":44},"Change in Parkinson's Symptom Severity","Changes in Parkinson's symptom severity determined by the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale",{"measure":56,"description":57,"timeFrame":44},"Change in Dyskinesia","Changes in dyskinesia determined by the Unified Dyskinesia Rating Scale (UDysRS) scale",{"measure":59,"description":60,"timeFrame":44},"Change in Pain","Changes in pain determined by the King's PD Pain Scale",{"measure":62,"description":63,"timeFrame":44},"Change in Fatigue","Changes in fatigue determined by the Parkinson's Fatigue Scale (PFS)",{"measure":65,"description":66,"timeFrame":44},"Change in Anhedonia","Changes in anhedonia determined by the Snaith-Hamilton Pleasure Scale (SHAPS)","ALL","40 Years","80 Years",{"inclusion":71,"exclusion":72,"raw_text":73},[],[],"Eligibility is determined in the ongoing parent clinical trial (KET-PD trial; NCT04944017, HIC 2000030394).",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"city":80,"state":81,"zip":82,"country":83,"geoPoint":84},"Yale New Haven Hospital","New Haven","Connecticut","06510","United States",{"lat":85,"lon":86},41.30815,-72.92816,[],[89],{"name":90,"affiliation":13,"role":91},"Sophie E. Holmes, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":95,"biomarkers":97},[20,96],"Parkinson Disease",[],{"nct_id":4,"found":15,"summary":24,"prompt_version":24}]