Ketamine for Older Adults Pilot

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-22

Study Completion Date

2022-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Ketamine Infusions to Treat Clinically-depressed ICU Patients

NCT05803551

Depression

RECRUITING PHASE2

Effect of Ketamine in Depressive Symptoms of Elderly Patients With Visual Impairment.

NCT03473431

Depression in Old Age Ketamine

COMPLETED NA

Antidepressant Effects of Nitrous Oxide

NCT05357040

Major Depressive Disorder Treatment Resistant Depression

RECRUITING PHASE2

Music as an Intervention to Improve Hemodynamic Tolerability of Ketamine in Depression

NCT04701866

Depressive Disorder, Treatment-Resistant Depressive Disorder, Major Unipolar Depression +1 more

COMPLETED NA

Study Protocol for a Smartphone Application-based Intervention for Subthreshold Depression

NCT04136041

Subthreshold Depression

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Treatment Resistant Depression Refractory Depression Therapy-Resistant Depression Late Life Depression Geriatric Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acute infusion

Acute phase: ketamine infusions twice a week for 4 weeks

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketamine

ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Community-living men and women age 65 years and older;
2. 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
3. Persistent moderate to severe depressive symptoms determined by Patient Health Questionnaire 9-item (PHQ-9)26 score ≥15 at baseline
4. Able to provide informed consent.

Exclusion Criteria

1. 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;
2. 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.
3. 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).
4. Baseline systolic BP \> 165 systolic or 100 diastolic at evaluation.
5. Current alcohol or substance use disorder or lifetime recreational ketamine use or other dissociative agent (e.g., PCP).
6. Use of naltrexone, memantine, or any medication that could be considered contraindicated with ketamine.
7. Taking more than 2 adequately-dosed oral antidepressants.
8. High acute risk for suicide and unable to be managed safely in the clinical trial.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No