Ketamine for Older Adults Pilot

Treatment Resistant Depression Clinical Trial

Official title:

Precision Medicine With Ketamine for Older Adults With Treatment-resistant Depression: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04504175
• Other study ID #: 202007085
• Status: Completed
• Phase: Phase 4
• Start date: October 22, 2020
• Est. completion date: March 15, 2022

Study information

• Verified date: February 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 15, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Geriatric Depression
• Late Life Depression
• Refractory Depression
• Therapy-Resistant Depression
• Treatment Resistant Depression

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario
United States	UCLA Late-Life Mood, Stress, and Wellness Research Program	Los Angeles	California
United States	Columbia University Adult and Late Life Depression Clinic	New York	New York
United States	UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program	Pittsburgh	Pennsylvania
United States	Washington University School of Medicine Healthy Mind Lab	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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