Ketamine for Older Adults Pilot

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.

Study Overview

• Status: Completed
• Conditions: Treatment Resistant Depression; Late Life Depression; Geriatric Depression; Refractory Depression; Therapy-Resistant Depression
• Intervention / Treatment: Drug: Ketamine

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6J-1H4
      • University Health Network
• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Late-Life Mood, Stress, and Wellness Research Program
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine Healthy Mind Lab
  • New York
    • New York, New York, United States, 10032
      • Columbia University Adult and Late Life Depression Clinic
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acute infusion; Acute phase: ketamine infusions twice a week for 4 weeks	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks for acute phase, 8 weeks for continuation phase

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 22, 2020
• Primary Completion (ACTUAL): November 30, 2021
• Study Completion (ACTUAL): March 15, 2022

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (ACTUAL): August 7, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: ketamine
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 202007085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No