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Trial record 4 of 57 for:    depression | Recruiting Studies | ketamine

Ketamine for Older Adults Pilot

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ClinicalTrials.gov Identifier: NCT04504175
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
Eric Lenze, Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Refractory Depression Therapy-Resistant Depression Late Life Depression Geriatric Depression Drug: Ketamine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Precision Medicine With Ketamine for Older Adults With Treatment-resistant Depression: Pilot Study
Actual Study Start Date : October 22, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Acute
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

Experimental: Continuation
Continuation: for remitters/ responders, 4 weeks of weekly ketamine infusions
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Change in Cognition [ Time Frame: 4 weeks and 8 weeks ]
    Measured by NIH Toolbox

  4. Change in Cognition [ Time Frame: 4 weeks and 8 weeks ]
    Measured by Miro Health Cognitive Batteries

  5. Change in Executive Function [ Time Frame: 4 weeks and 8 weeks ]
    Measured by NIH Toolbox

  6. Change in Executive Function [ Time Frame: 4 weeks and 8 weeks ]
    Measured by Miro Health Cognitive Batteries

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04504175


Contacts
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Contact: Emily Lenard, MSW 3147475706 lenarde@wustl.edu
Contact: Julie Schweiger, CCRC 314-362-3153 schweigj@wustl.edu

Locations
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United States, California
UCLA Late-Life Mood, Stress, and Wellness Research Program Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Yesenia Aguilar Faustino    310-825-2065    yafaustino@mednet.ucla.edu   
Contact: Raquel Hernandez Sotomayor    310-267-5264    RHernandezSotomayor@mednet.ucla.edu   
Principal Investigator: Helen Lavretsky, MD         
United States, Missouri
Washington University School of Medicine Healthy Mind Lab Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Emily Lenard, MSW    314-747-5706    lenarde@wustl.edu   
Contact: Julie Schweiger, CCRC    314-362-3153    schweigj@wustl.edu   
Principal Investigator: Eric Lenze, MD         
United States, New York
Columbia University Adult and Late Life Depression Clinic Recruiting
New York, New York, United States, 10032
Contact: Carolina Montes Garcia    646-774-8648    carolina.montes@nyspi.columbia.edu   
Contact: Esteban Ceballos    646-774-8670    esteban.ceballos@nyspi.columbia.edu   
Principal Investigator: Steven Roose, MD         
Sub-Investigator: Patrick Brown, PhD         
United States, Pennsylvania
UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Joelle Kincman, PhD    412-246-6012    scanjm2@upmc.edu   
Contact: Sunita Chickering    412-246-6021    chickeringsn@upmc.edu   
Principal Investigator: Jordan Karp, MD         
Sub-Investigator: Marie Ann Gebara, MD         
Canada, Ontario
University Health Network Not yet recruiting
Toronto, Ontario, Canada, M6J-1H4
Contact: Athina Perivolaris, RN, MN    416-535-8501 ext 32897    athina.perivolaris@camh.ca   
Contact: Nisha Patel       Nisha.Patel@uhnresearch.ca   
Principal Investigator: Alastair Flint, MD         
Sub-Investigator: Benoit Mulsant, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Eric Lenze, MD Washington University School of Medicine
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Responsible Party: Eric Lenze, Professor of Psychiatry, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04504175    
Other Study ID Numbers: 202007085
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Eric Lenze, Washington University School of Medicine:
ketamine
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action