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Intranasal Ketamine for Late-Life Depression and Suicidal Ideation

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ClinicalTrials.gov Identifier: NCT02295787
Recruitment Status : Withdrawn (No funding)
First Posted : November 20, 2014
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Dawn F Ionescu, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Depression Suicide Suicidal Ideation Drug: Ketamine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Ketamine for Late-Life Depression and Suicidal Ideation
Study Start Date : July 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine
Intranasal Ketamine 50mg administered six times over three weeks.
Drug: Ketamine
Intranasal ketamine for late-life depression and suicidal ideation.

Placebo Comparator: Placebo
Intranasal saline solution administered six times over three weeks.
Drug: Placebo



Primary Outcome Measures :
  1. Hamilton Depression Rating Scale (HDRS) [ Time Frame: Up to 4 months ]


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) 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.

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), or 8) concurrent or recent participation in other research studies.

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): NCT02295787


Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Dawn F Ionescu, MD Massachusetts General Hospital
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Responsible Party: Dawn F Ionescu, Assistant in Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02295787    
Other Study ID Numbers: 2014D006212
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Keywords provided by Dawn F Ionescu, Massachusetts General Hospital:
Depression
Suicide
Suicidal Ideation
Ketamine
Late-Life
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Suicide
Suicidal Ideation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Self-Injurious Behavior
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