Actively Recruiting
Esketamine With or Without Integration Therapy for Treatment-Resistant Depression
Led by University of Puerto Rico · Updated on 2026-01-27
20
Participants Needed
2
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The 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. Participants will be randomly assigned to one of two groups: Esketamine 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. The 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.
CONDITIONS
Official Title
Esketamine With or Without Integration Therapy for Treatment-Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 to 65 years
- Diagnosed with current Major Depressive Disorder confirmed by SCID-5
- Have not achieved remission after trying at least two antidepressants at adequate dose and duration
- Baseline depression severity with MADRS score of 30 or higher
- May have passive or active suicidal thoughts but must be clinically stable for outpatient care
- Able to understand and provide written informed consent
- Willing to use effective contraception during the study and for one month after final dose if of reproductive potential
- Willing and able to attend all study sessions and complete procedures
- Motivated and psychologically ready to participate in guided preparation and integration sessions
You will not qualify if you...
- Immediate risk of suicide requiring inpatient hospitalization
- Current diagnosis of bipolar I disorder (manic phase), schizophrenia, schizoaffective disorder, or other primary psychotic disorders
- Active moderate to severe substance use disorder (except nicotine) in past 6 months
- Intellectual disability, dementia, or cognitive/developmental disorders impairing participation in therapy sessions
- Medical conditions posing risk during esketamine treatment (e.g., aneurysmal vascular disease, intracerebral hemorrhage, hypersensitivity to esketamine/ketamine)
- Currently pregnant or breastfeeding
- Participation in formal psychotherapy focused on behavioral change or emotional processing within past 3 months, unless stabilized for at least 8 weeks
- Six or more prior esketamine or IV ketamine sessions without clinical response
- Use of ketamine/esketamine in past 12 weeks
- Unable to provide informed consent
- Previous participation in this study
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Pravan Foundation
San Juan, Puerto Rico, 00909
Actively Recruiting
2
University of Puerto Rico, Department of Psychiatry
San Juan, Puerto Rico, 00936
Actively Recruiting
Research Team
P
Paulina D Rullan-Farinacci, MD
CONTACT
K
Karen G Martinez-Gonzalez, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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