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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label | Experimental | Open label, single arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine-assisted psychotherapy | Drug | Ketamine-assisted psychotherapy delivered in a group format |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate feasibility of a culturally adapted group-based ketamine intervention for Spanish- speaking adults with depression in a community setting | (a) Assess the attendance and adherence rates of participants to the group-based ketamine intervention sessions; (b) Evaluate the feasibility of delivering the intervention sessions as planned, including the preparatory, dosing, and integration sessions; (c) Explore the perceptions and experiences of Spanish-speaking participants regarding the intervention. | 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. | (a) assess safety as obtained through vital monitoring; heart-rate variability (HRV) monitoring, EKG, as measured by a Fitbit. (b) evaluate physical and psychological adverse effects at each study visit. | 1 week post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the preliminary efficacy of the group-based ketamine intervention on psychiatric symptoms, wellbeing, and health behaviors among Spanish-speaking participants with depression. | (a) Assess changes in psychiatric symptom scales pre- and post-intervention using validated assessment tools. (b) Measure changes in wellbeing (social wellbeing, personal wellbeing, spiritual health) pre- and post- intervention through self-report scales. Explore shifts in health behaviors pre-and post-intervention, through self-report and accelerometry measures. |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juliana Zambrano, MD | Contact | 617-726-2000 | JZAMBRANO2@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Juliana Zambrano, MD | Massachusetts General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital, Chelsea | Recruiting | Chelsea | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 1 and 12 weeks post-intervention |