Intranasal Ketamine for Late-Life Depression and Suicidal Ideation

NCT02295787 | Withdrawn Phase 4 DMC

• 1 other identifier: 2014D006212
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators of this study plan to investigate the feasibility and efficacy of repeated doses of intranasal ketamine in severely depressed patients who are at least 65 years of age and experiencing suicidal ideation. The results of the study could lead to development of new strategies for treating depression.

Conditions

Depression; Suicide; Suicidal Ideation

Keywords

Depression; Suicide; Suicidal Ideation; Ketamine; Late-Life

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HDRS)

  Up to 4 months

Study Arms (2)

Ketamine

EXPERIMENTAL

Intranasal Ketamine 50mg administered six times over three weeks.

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

Intranasal saline solution administered six times over three weeks.

Drug: Placebo

Interventions

Ketamine DRUG

Intranasal ketamine for late-life depression and suicidal ideation.

Ketamine

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• \) be ≥65 years old, 2) provide written informed consent, 3) meet criteria for a primary psychiatric diagnosis of major depressive disorder according to the Structured Clinical Interview for DSM-IV (SCID) and have a HDRS28 total score ≥20; depression may have started at any time point in their life, and certain co-morbid diagnoses (e.g., anxiety disorders) will be allowed insofar as they are not the primary psychiatric diagnosis, 4) have a history of ≥2 failed medication trials during the current episode (per the Massachusetts General Hospital Antidepressant Treatment History Questionnaire; MGH ATRQ), 5) endorse suicidal ideation for more than 2 months, per the Columbia Suicide Severity Rating Scale (C-SSRS) and have a HDRS28 suicide item score ≥1 (thoughts that life isn't worth living), 6) be on a stable antidepressant regimen for ≥14 days prior to Study Phase II, 7) maintain a treating psychiatrist who is in agreement with study participation, and 8) have a reliable chaperone accompany them home following the completion of the intranasal administration.

You may not qualify if:

• Patients will be excluded if any of the following criteria are met: 1) Delirium or dementia diagnosis, 2) unstable medical illness, 3) history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects, 4) history of multiple adverse drug reactions, 5) current/past history of psychotic disorders or homicidality, 6) active substance use disorders (except nicotine and caffeine) within the past six months, positive urine toxicology screen, or past history of ketamine abuse, 7) requirement of excluded medications (narcotics, barbiturates, theophylline, or St. John's Wort), or 8) concurrent or recent participation in other research studies.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Depression; Suicide; Suicidal Ideation

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Injurious Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dawn F Ionescu, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Psychiatry

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 20, 2014
• Study Start: July 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 3, 2017

Record last verified: 2017-03