Trials / Completed
CompletedNCT04504175
Ketamine for Older Adults Pilot
Precision Medicine With Ketamine for Older Adults With Treatment-resistant Depression: Pilot Study
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
This pilot study will assess the safety and feasibility of intravenous (IV) ketamine in older adults with Treatment-Resistant Depression (TRD). In addition, this study will develop and utilize innovative methodological approaches to demonstrate the feasibility of precision medicine and mobile health approaches in depression treatment.
Detailed description
Participants in this study will receive ketamine infusions twice a week for 4 weeks (acute phase). Participants who respond or remit will continue with an additional 4 weeks of weekly ketamine infusions (continuation phase). Participants will be assessed at baseline, end of acute phase, and end of continuation phase for effectiveness, safety, and executive functioning. Participants will be asked to complete daily surveys of their depression symptoms during their participation.
Conditions
- Treatment Resistant Depression
- Refractory Depression
- Therapy-Resistant Depression
- Late Life Depression
- Geriatric Depression
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ketamine | ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes |
Timeline
- Start date
- 2020-10-22
- Primary completion
- 2021-11-30
- Completion
- 2022-03-15
- First posted
- 2020-08-07
- Last updated
- 2023-02-14
- Results posted
- 2023-02-08
Locations
5 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04504175. Inclusion in this directory is not an endorsement.