Intranasal Ketamine for Late-Life Depression and... — Clinical Trial Details

Phase IV interventional

Randomized, quadruple Blind

Randomized, parallel-group, Phase IV trial planned to evaluate feasibility and efficacy of repeated intranasal ketamine (50 mg, six administrations over three weeks) in adults aged 65+ with major depressive disorder and persistent suicidal ideation.

Key eligibility required HDRS28 ≥20, ≥2 failed antidepressant trials in the current episode, and suicidal ideation >2 months; major exclusions included dementia, unstable medical or significant cardiac disease, psychotic disorders, active substance use disorder, and recent ketamine abuse.

Study Protocol

Preparation

sessions

Dosing

6 sessions

Inclusion Criteria:
1) 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
8) have a reliable chaperone accompany them home following the completion of the intranasal administration.

Exclusion Criteria:
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)
8) concurrent or recent participation in other research studies.

Start: 2015-01-07

End: 2015-01-07

Company

Product

Legal

Intranasal Ketamine for Late-Life Depression and Suicidal Ideation

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

Ketamine

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators