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Ketamine for Older Adults Pilot

Primary Purpose

Treatment Resistant Depression, Refractory Depression, Therapy-Resistant Depression

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ketamine
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression focused on measuring ketamine

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA Late-Life Mood, Stress, and Wellness Research Program
  • Washington University School of Medicine Healthy Mind Lab
  • Columbia University Adult and Late Life Depression Clinic
  • UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program
  • University Health Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute infusion

Arm Description

Acute phase: ketamine infusions twice a week for 4 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 30, 2020
Last Updated
February 10, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04504175
Brief Title
Ketamine for Older Adults Pilot
Official Title
Precision Medicine With Ketamine for Older Adults With Treatment-resistant Depression: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression, Refractory Depression, Therapy-Resistant Depression, Late Life Depression, Geriatric Depression
Keywords
ketamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute infusion
Arm Type
Experimental
Arm Description
Acute phase: ketamine infusions twice a week for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes
Primary Outcome Measure Information:
Title
Remission From Depression
Description
Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depression severity.
Time Frame
4 weeks for acute phase, 8 weeks for continuation phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Lenze, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Late-Life Mood, Stress, and Wellness Research Program
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Washington University School of Medicine Healthy Mind Lab
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia University Adult and Late Life Depression Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J-1H4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Ketamine for Older Adults Pilot

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