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Ketamine for Older Adults Pilot

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ClinicalTrials.gov Identifier: NCT04504175
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
Eric Lenze, Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE July 30, 2020
First Posted Date  ICMJE August 7, 2020
Last Update Posted Date November 26, 2021
Actual Study Start Date  ICMJE October 22, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2020)
Remission from Depression [ Time Frame: 4 weeks ]
Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depression severity.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2020)
  • Change in Depression Severity [ Time Frame: 4 weeks and 8 weeks ]
    Measured by Montgomery Asberg Depression Rating Scale. Scale ranges from 0-60 with higher scores indicating higher depression severity.
  • Psychological Well-Being [ Time Frame: 4 weeks and 8 weeks ]
    Measured by NIH Toolbox Psychological Well-Being Surveys, Positive Affect and General Life Satisfaction. These two subscales are part of the Psychological Well-Being construct of the NIH Toolbox Emotion domain. For both scales, scores are presented as a t-score, with higher scores indicating higher positive affect and general life satisfaction.
  • Change in Cognition [ Time Frame: 4 weeks and 8 weeks ]
    Measured by NIH Toolbox
  • Change in Cognition [ Time Frame: 4 weeks and 8 weeks ]
    Measured by Miro Health Cognitive Batteries
  • Change in Executive Function [ Time Frame: 4 weeks and 8 weeks ]
    Measured by NIH Toolbox
  • Change in Executive Function [ Time Frame: 4 weeks and 8 weeks ]
    Measured by Miro Health Cognitive Batteries
  • Change in Suicidal Ideation [ Time Frame: 4 weeks and 8 weeks ]
    Measured by Scale for Suicidal Ideation. Scores range from 0-38 with higher scores indicating higher severity of suicidal ideation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine for Older Adults Pilot
Official Title  ICMJE Precision Medicine With Ketamine for Older Adults With Treatment-resistant Depression: Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Treatment Resistant Depression
  • Refractory Depression
  • Therapy-Resistant Depression
  • Late Life Depression
  • Geriatric Depression
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Acute
    Acute phase: ketamine infusions twice a week for 4 weeks
    Intervention: Drug: Ketamine
  • Experimental: Continuation
    Continuation: for remitters/ responders, 4 weeks of weekly ketamine infusions
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 4, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emily Lenard, MSW 3147475706 lenarde@wustl.edu
Contact: Julie Schweiger, CCRC 314-362-3153 schweigj@wustl.edu
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04504175
Other Study ID Numbers  ICMJE 202007085
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eric Lenze, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Lenze, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP