Treatment Resistant DepressionPhase 4NCT04504175
Ketamine for Older Adults Pilot
A Phase 4 study testing Ketamine in people with Treatment Resistant Depression and Refractory Depression, run by Washington University School of Medicine at 5 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Treatment Resistant Depression, Refractory Depression, Therapy-Resistant Depression
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 22 Oct 2020to 15 Mar 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Community-living men and women age 65 years and older;
- Treatment-resistant depression: defined as unipolar major depressive disorder, non-delusional (diagnosed by SCID-5) that persists despite ≥ 2 adequate antidepressant trials of different classes in the current episode; including at least one evidence-based second-line treatment in the current episode (including serotonin norepinephrine reuptake inhibitors, bupropion, tricyclics, monoamine oxidase inhibitors, or augmentation with an atypical antipsychotic, stimulant, bupropion, lithium, or triiodothyronine
- Persistent moderate to severe depressive symptoms determined by Patient Health Questionnaire 9-item (PHQ-9)26 score ≥15 at baseline
- Able to provide informed consent.
Who cannot join
- Dementia per history, score < 24 on the Montreal Cognitive Assessment (MoCA), or determined by clinical interview with geriatric psychiatrist to have high likelihood of dementia;
- Psychotic spectrum or bipolar disorder or severe personality disorder that at the PIs discretion would interfere with safe participation. Anxiety disorders are not an exclusion.
- Unstable medical conditions such that IV ketamine is not safe or tolerated or that would interfere with participation in a long-term study (i.e., poorly controlled hypertension, life expectancy < 1 year because of terminal illness, unstable angina).
- Baseline systolic BP > 165 systolic or 100 diastolic at evaluation.
- Current alcohol or substance use disorder or lifetime recreational ketamine use or other dissociative agent (e.g., PCP).
- Use of naltrexone, memantine, or any medication that could be considered contraindicated with ketamine.
- Taking more than 2 adequately-dosed oral antidepressants.
- High acute risk for suicide and unable to be managed safely in the clinical trial.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
UCLA Late-Life Mood, Stress, and Wellness Research Program
Los Angeles, California, 90095
Columbia University Adult and Late Life Depression Clinic
New York, New York, 10032
UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program
Pittsburgh, Pennsylvania, 15213
Washington University School of Medicine Healthy Mind Lab
St Louis, Missouri, 63110
About this study
Official title: Precision Medicine With Ketamine for Older Adults With Treatment-resistant Depression: Pilot Study
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.
Read the 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
- Being tested
- Ketamine
- Keywords
- ketamine
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes
| Study group | Role | What they receive |
|---|---|---|
| Acute infusion | Experimental | Acute phase: ketamine infusions twice a week for 4 weeks Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission From Depression
Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depression severity.
Measured: 4 weeks for acute phase, 8 weeks for continuation phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start22 Oct 2020
- Primary completion30 Nov 2021
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Lenze, Washington University School of Medicine
- Investigators
- Eric Lenze, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504175
- Sponsor's protocol ID
- 202007085
- Status last verified
- Feb 2023
- First submitted
- 30 Jul 2020
- Last updated
- 14 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vanderschelden B, Gebara MA, Oughli HA, Butters MA, Brown PJ, Farber NB, Flint AJ, Karp JF, Lavretsky H, Mulsant BH, Reynolds CF 3rd, Roose SP, Lenze EJ. Change in patient-centered outcomes of psychological well-being, sleep, and suicidality following treatment with intravenous ketamine for late-life treatment-resistant depression. Int J Geriatr Psychiatry. 2023 Jul;38(7):e5964. doi: 10.1002/gps.5964.
PubMed 37392089
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine With Ketamine for Older Adults With Treatment-resistant Depression: Pilot Study
- ClinicalTrials.gov ID
- NCT04504175
- Acronym / sponsor ID
- 202007085
- Conditions
- Treatment Resistant Depression, Refractory Depression, Therapy-Resistant Depression, Late Life Depression, Geriatric Depression
- Keywords
- ketamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute infusion | Experimental | Drug: KetamineAcute phase: ketamine infusions twice a week for 4 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Community-living men and women age 65 years and older;
- Treatment-resistant depression: defined as unipolar major depressive disorder, non-delusional (diagnosed by SCID-5) that persists despite ≥ 2 adequate antidepressant trials of different classes in the current episode; including at least one evidence-based second-line treatment in the current episode (including serotonin norepinephrine reuptake inhibitors, bupropion, tricyclics, monoamine oxidase inhibitors, or augmentation with an atypical antipsychotic, stimulant, bupropion, lithium, or triiodothyronine
- Persistent moderate to severe depressive symptoms determined by Patient Health Questionnaire 9-item (PHQ-9)26 score ≥15 at baseline
- Able to provide informed consent.
Key exclusion criteria (8 listed)
- Dementia per history, score < 24 on the Montreal Cognitive Assessment (MoCA), or determined by clinical interview with geriatric psychiatrist to have high likelihood of dementia;
- Psychotic spectrum or bipolar disorder or severe personality disorder that at the PIs discretion would interfere with safe participation. Anxiety disorders are not an exclusion.
- Unstable medical conditions such that IV ketamine is not safe or tolerated or that would interfere with participation in a long-term study (i.e., poorly controlled hypertension, life expectancy < 1 year because of terminal illness, unstable angina).
- Baseline systolic BP > 165 systolic or 100 diastolic at evaluation.
- Current alcohol or substance use disorder or lifetime recreational ketamine use or other dissociative agent (e.g., PCP).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamineketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes | Drug | Acute infusion |
Primary outcome
Remission From Depression
Time frame: 4 weeks for acute phase, 8 weeks for continuation phase
Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depression severity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37392089Vanderschelden B, Gebara MA, Oughli HA, Butters MA, Brown PJ, Farber NB, Flint AJ, Karp JF, Lavretsky H, Mulsant BH, Reynolds CF 3rd, Roose SP, Lenze EJ. Change in patient-centered outcomes of psychological well-being, sleep, and suicidality following treatment with intravenous ketamine for late-life treatment-resistant depression. Int J Geriatr Psychiatry. 2023 Jul;38(7):e5964. doi: 10.1002/gps.5964.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Lenze, MD principal investigator
Washington University School of Medicine
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine in people with Treatment Resistant Depression and Refractory Depression, run by Washington University School of Medicine at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission From Depression (time frame: 4 weeks for acute phase, 8 weeks for continuation phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04504175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023; AzTrials last refreshed its copy on 29 Oct 2026.