Ketamine for Older Adults Pilot

NCT04504175 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 202007085
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 5

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.

Conditions

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

Keywords

ketamine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Acute infusion

EXPERIMENTAL

Acute phase: ketamine infusions twice a week for 4 weeks

Drug: Ketamine

Interventions

Ketamine DRUG

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

Acute infusion

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (5)

UCLA Late-Life Mood, Stress, and Wellness Research Program

Los Angeles, California, 90095, United States

Location

Washington University School of Medicine Healthy Mind Lab

St Louis, Missouri, 63110, United States

Location

Columbia University Adult and Late Life Depression Clinic

New York, New York, 10032, United States

Location

UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program

Pittsburgh, Pennsylvania, 15213, United States

Location

University Health Network

Toronto, Ontario, M6J-1H4, Canada

Location

Related Publications (1)

• Vanderschelden B, Gebara MA, Oughli HA, Butters MA, Brown PJ, Farber NB, Flint AJ, Karp JF, Lavretsky H, Mulsant BH, Reynolds CF 3rd, Roose SP, Lenze EJ. Change in patient-centered outcomes of psychological well-being, sleep, and suicidality following treatment with intravenous ketamine for late-life treatment-resistant depression. Int J Geriatr Psychiatry. 2023 Jul;38(7):e5964. doi: 10.1002/gps.5964.

  PMID: 37392089 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Eric Lenze
• Organization: Washington University in St. Louis

lenzee@wustl.edu

314-362-5154

Study Officials

• Eric Lenze, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 7, 2020
• Study Start: October 22, 2020
• Primary Completion: November 30, 2021
• Study Completion: March 15, 2022
• Last Updated: February 14, 2023
• Results First Posted: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (4)