A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketamine-assisted psychotherapy.
- Who it may be relevant to
- Registry conditions: Depression. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This is a pilot clinical trial to assess the feasibility, safety, and preliminary efficacy of ketamine-assisted group therapy for Spanish-speaking adults with depression
Interventions
- Drug Ketamine-assisted psychotherapy
Ketamine-assisted psychotherapy delivered in a group format
Primary outcome measures
- Evaluate feasibility of a culturally adapted group-based ketamine intervention for Spanish- speaking adults with depression in a community setting [Time frame: 1 week post-intervention]
- To assess the safety of a ketamine-assisted group psychotherapy intervention for Spanish-speaking participants with depression in a community setting. [Time frame: 1 week post-intervention]
Secondary outcome measures (1)
- Investigate the preliminary efficacy of the group-based ketamine intervention on psychiatric symptoms, wellbeing, and health behaviors among Spanish-speaking participants with depression. [Time frame: 1 and 12 weeks post-intervention]
Eligibility criteria
Inclusion criteria
1\. Self-identifying Latinx, Spanish-speaking 2. Adults 18-64 years 3. Meet DSM-5 criteria for major depressive disorder as evaluated by study clinician 4. Montgomery-Asberg depression scale (MADRS) score of 20 or above at baseline 4. Participants must have an MGB psychiatrist and primary care provider.
Exclusion criteria
- History of primary psychotic disorder, by history
- History Bipolar I disorder, by history
- Unstable complex PTSD, as assessed by study clinician
- History of dissociative identity disorder
- History of neurocognitive disorder
- History of severe and/or recent substance use disorder, by history and as assessed by study clinician after clinical evaluation and interview
- Uncontrolled hypertension, tachycardia, or unstable cardiopulmonary disease, by history a. Blood pressure on initial screen must be <140/90 mmHg.
- History of aortic dissection
- History of myocardial infarction
- History of aneurysm
- History of hepatic impairment.
- History of epilepsy
- History of prior hypersensitivity to ketamine
- Body Mass Index greater than 35
- Body Mass Index less than 18.5
- Are pregnant, breastfeeding, or planning to become pregnant within 12 weeks of treatment completion
- Enrolled in other clinical trial for the treatment of depression or other behavioral health diagnosis
- Inability to provide consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Massachusetts General Hospital, Chelsea — Chelsea
Identifiers
NCT: NCT06597695 · 2024P002122