Phase 2
Completed N=43
Ketamine + Mindfulness for Depression
Depression, Unipolar
Source: ClinicalTrials.gov NCT05168735 ↗
Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Montgomery-Asberg Depression Rating Scale — 12.50; 13.30 score on a scale
Summary
In this project, the investigators will administer a single infusion of IV ketamine to depressed patients and randomize the patients to receive either a) usual/typical infusion conditions or b) mindfulness training and exercises in conjunction with the infusion. Investigators will test whether the conjunction of ketamine + mindfulness enhances the reductions in depression following a single ketamine infusion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery-Asberg Depression Rating Scale |
18.55; 20.05 | — |
| PRIMARY State Mindfulness Scale |
77.68; 83.33 | — |
| SECONDARY Modified Hamilton Depression Rating Scale |
12.69; 12.45 | — |
| SECONDARY Quick Inventory of Depressive Symptoms |
9.30; 8.47 | — |
| SECONDARY Hood Mysticism Scale |
-.05; .05 | — |
| SECONDARY Mindful Attention Awareness Scale |
3.81; 3.94 | — |
| SECONDARY Daily Spiritual Experience Scale |
2.52; 2.34 | — |
Eligibility Criteria
Inclusion Criteria
All participants will:
- be between the ages of 18 and 65 years,
- score ≥ 14 on the Hamilton Depression Rating Scale (modified Ham-D)
- possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
Exclusion Criteria
All participants:
- Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder);
- Acute suicidality or other psychiatric crises requiring treatment escalation. We will use the Columbia Suicide Severity Rating Scale (CSSRS) as both an initial exclusion criteria (CSSRS "Baseline/Screening" Version for past 1month period) and as grounds for rescue/removal (CSSRS "Since Last Visit" form). The CSSRS will be administered using a paper form by an experienced and thoroughly trained clinical assessor on the study team. Subjects with CSSRS suicide ideation scores scored "yes" on items 4 (active suicidal ideation with some intent to act) and/or 5 (active suicidal ideation with specific plan and intent) will be excluded from the study, and if enrolled, will be exited from the study and referred immediately to the nearest emergency mental health facility for additional thorough assessment and appropriate treatment referral.
- Changes made to treatment regimen within 4 weeks of baseline assessment.
- Reading level 1 hour weekly (on average) for the past 6 months or longer.
Data sourced from ClinicalTrials.gov (NCT05168735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.