[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621321":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":76,"collaborators":33,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":33,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":52,"whyStopped":33,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"University of Puerto Rico","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Esketamine With Integration Therapy","EXPERIMENTAL","Participants in this arm will receive FDA-approved intranasal esketamine (Spravato®) twice weekly during the acute phase (weeks 1-4), followed by weekly or biweekly dosing during the maintenance phase (weeks 5-8), based on clinical response. In addition, participants will receive brief, structured therapeutic sessions for preparation and integration before and after each dosing session. These sessions are designed to support emotional processing, meaning-making, and therapeutic engagement.",[13,14],"Drug: Esketamine hydrochloride (intranasal)","Behavioral: Integration Therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Esketamine Without Integration Therapy","ACTIVE_COMPARATOR","Participants in this arm will receive FDA-approved intranasal esketamine (Spravato®) twice weekly during the acute phase (weeks 1-4), followed by weekly or biweekly dosing during the maintenance phase (weeks 5-8), based on clinical response. No additional psychotherapeutic support will be provided beyond standard clinical monitoring and psychiatric care.",[13],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Esketamine hydrochloride (intranasal)","Intranasal esketamine (Spravato®), administered under medical supervision in accordance with FDA guidelines for treatment-resistant depression. Dosing schedule includes twice-weekly administration during weeks 1-4 (acute phase), followed by weekly or biweekly administration during weeks 5-8 (maintenance phase), based on clinical response and tolerability. All dosing occurs in a clinical setting with standard monitoring for at least two hours post-administration.",[9,16],[27],"Spravato",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BEHAVIORAL","Integration Therapy","Brief, structured psychotherapeutic sessions delivered before and after each esketamine dose, based on psychedelic-assisted therapy principles. Sessions are designed to support emotional safety, preparation for the treatment experience, and integration of psychological content that may arise. Conducted by trained clinicians following a standardized framework developed for this study. Only participants in the experimental arm receive this intervention.",[9],null,[35],{"name":36,"affiliation":37,"role":38},"Karen G Gonzalez-Martinez, MD, MSc","University of Puerto Rico, Medical Sciences Campus, Department of Psychiatry","STUDY_CHAIR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":33,"email":44},"Paulina D Rullan-Farinacci, MD","CONTACT","787-414-3571","paulina.rullan@upr.edu",{"name":46,"role":42,"phone":47,"phoneExt":33,"email":48},"Karen G Martinez-Gonzalez, MD, MSc","787-617-5557","karen.martinez4@upr.edu",[50,68],{"facility":51,"status":52,"city":53,"state":33,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Pravan Foundation","RECRUITING","San Juan","00909","Puerto Rico","PR",{"type":58,"coordinates":59},"Point",[60,61],-66.10572,18.46633,{"lat":61,"lon":60},[64],{"name":65,"role":42,"phone":66,"phoneExt":33,"email":67},"David Melchor","787-427-7000","david.melchor@pravanfoundation.org",{"facility":69,"status":52,"city":53,"state":33,"zip":70,"country":55,"countryCode":56,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"University of Puerto Rico, Department of Psychiatry","00936",{"type":58,"coordinates":72},[60,61],{"lat":61,"lon":60},[75],{"name":46,"role":42,"phone":47,"phoneExt":33,"email":48},{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Paulina Rullan-Farinacci","Principal Investigator","100621321","phase-4-esketamine-with-or-without-integration-therapy-for-treatment-resistant-depression-100621321",false,"NCT07369102","Esketamine With or Without Integration Therapy for Treatment-Resistant Depression","Esketamine With or Without Psychedelic Preparation and Integration for Treatment-Resistant Depression: A Randomized Controlled Trial","KIND-PR","Inclusion Criteria:\n\n* Age: Adults aged 21 to 65 years.\n* Diagnosis: Current Major Depressive Disorder (MDD) as confirmed by Structured Clinical Interview for DSM5 (SCID-5).\n* Treatment Resistance: Failure to achieve remission with at least two antidepressants of adequate dose and duration (TRD criteria) as confirmed by SCID-5.\n* Symptom Severity: Baseline Montgomery-Åsberg Depression Rating Scale (MADRS) ≥30.\n* Suicidal Ideation: Participants with baseline passive or active suicidal ideation may be included, provided they do not meet criteria for inpatient admission and are deemed clinically stable for outpatient care. This will be measured with the Columbia Suicide Severity Rating Scale (C-SSRS).\n* Consent: Ability to understand and voluntarily provide written informed consent.\n* Contraception: For participants of reproductive potential, willingness to use at least one highly effective method of contraception (e.g., intrauterine device, hormonal contraception, sterilization) or two effective methods (e.g., barrier method plus spermicide) during the study and for at least one month after the final esketamine dose. Contraceptive method(s) will be documented at baseline via self-report on a standardized form and reaffirmed at each esketamine session by research staff. Participants who become pregnant or are unable to confirm adequate contraception will be withdrawn from the study for safety reasons.\n* Availability: Willingness and ability to attend all scheduled sessions and complete study procedures.\n* Motivation for Engagement: Demonstrates willingness and psychological readiness to engage in guided reflective work before and after esketamine dosing (as assessed during clinical intake).\n\nExclusion Criteria:\n\n* Acute Suicide Risk: Immediate need for inpatient psychiatric hospitalization due to suicidal ideation with plan or intent as identified through the C-SSRS.\n* Psychotic or Bipolar Disorders: Current diagnosis of bipolar I disorder (manic phase), schizophrenia, schizoaffective disorder, or other primary psychotic disorders if stated by participants as a past diagnosis or identified during the SCID-5.\n* Substance Use Disorder: Active moderate to severe substance use disorder (except nicotine) in the past 6 months as self-identified by participant or during the SCID-5.\n* Cognitive\u002FDevelopmental Impairments: Intellectual disability, dementia, or other cognitive\u002Fdevelopmental disorders that impair ability to engage meaningfully in structured psychotherapeutic sessions such as preparation or integration, per clinician judgment.\n* Medical Contraindications: Any medical condition judged to pose undue risk during esketamine administration (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, or hypersensitivity to esketamine\u002Fketamine).\n* Pregnancy\u002FBreastfeeding: Current pregnancy or breastfeeding.\n* Ongoing Structured Psychotherapy Likely to Confound Outcomes: Participation in any formal psychotherapy within the past 3 months that involves structured, weekly sessions focused on behavioral change or emotional processing (e.g., CBT, ACT, psychodynamic therapy), unless the therapy was completed or stabilized at a low-intensity level for at least 8 weeks prior to enrollment.\n* Prior Non-Response to Esketamine: Six or more prior esketamine (≥56 mg) or IV ketamine sessions (0.4-0.7 mg\u002Fkg) without clinical response.\n* Recent Ketamine Use: Use of ketamine\u002Fesketamine in the past 12 weeks.\n* Inability to Consent: Any condition rendering the participant unable to provide informed consent.\n* Prior Enrollment: Previous participation in this study.","ALL","21 Years","65 Years",{"count":92,"type":93},20,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","This study will explore the effects of esketamine (Spravato®), an FDA-approved nasal spray, on adults diagnosed with treatment-resistant depression (TRD). All participants will receive esketamine as prescribed by a healthcare professional in a clinical setting.\n\nThe purpose of this research is to understand whether adding therapeutic support in the form of preparation and integration sessions - before and after the esketamine doses - can enhance the treatment experience and lead to longer-lasting improvements in mood and functioning.\n\nParticipants will be randomly assigned to one of two groups:\n\nEsketamine with therapeutic support sessions (integration group) Esketamine without additional support (standard care group) Both groups will receive standard monitoring and psychiatric evaluation during the study. The support sessions offered in the integration group are designed to help participants prepare for their treatment sessions and make sense of their experiences afterward, using a structured, evidence-based approach.\n\nThe study will last approximately 8 weeks per participant, with follow-up assessments. The goal is to learn whether integration therapy can improve treatment outcomes, safety, and satisfaction for individuals with depression that hasn't responded to other treatments.",[99],"Treatment-resistant Depression (TRD)",[101,102,27,103,104,105,30,106,107,108,109,110,111,112,113],"esketamine","Treatment-Resistant Depression","Ketamine-Assisted Psychotherapy","Psychedelic Integration","Depression","Preparation and Integration","Mental Health","Dissociation","Intranasal Esketamine","Randomized Controlled Trial","Psychiatric Treatment","Therapeutic Support","Psychedelic Medicine","2026-01-23",{"date":116,"type":117},"2026-01-27","ACTUAL",{"date":119,"type":93},"2026-02-01",{"date":121,"type":93},"2026-12-01",{"name":5,"class":6},2]