The Impact of Ketamine on the Reward Circuitry of Suicidal Patients

NCT02532153 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 2015P001783
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Every 40 seconds, someone in the world dies by suicide. There is a lack of effective and safe antisuicidal agents for preventing suicide attempts. This leads to the immense worldwide individual, financial, and societal burden of suicide-which is projected to rise in the coming decades-supporting the need for antisuicidal treatments. This treatment gap may be filled through understanding the neurobiology of suicide, which can guide the development of targeted antisuicidal treatments. Though some research has examined the neurobiology of suicidal ideation in the context of depression-implicating the orbital frontal cortex, anterior cingulate cortex, and striatum-the underlying pathophysiology and neurobiology of suicidal ideation as a separate construct from depression remains largely unknown. Therefore, the investigators propose to study the neurocircuitry of suicidal thoughts, regardless of whether or not depression is present.

Conditions

Suicidal Ideation; Suicide

Keywords

Suicidal Ideation; Suicide; Suicidal Thoughts; Depression; Ketamine

Outcome Measures

Primary Outcomes (1)

• Columbia Suicide Severity Rating Scale (C-SSRS)

  Suicide Rating Scale from 1-5; higher numbers indicate increased suicidal thinking

  2 weeks

Study Arms (1)

Open-Label Ketamine

OTHER

Drug: Ketamine Hydrochloride

Interventions

Ketamine Hydrochloride DRUG

Single open-label infusions

Open-Label Ketamine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will:
• be ≥18 years old,
• read, understand, and provide written informed consent,
• have suicidal ideation for ≥ 2 months, per the Columbia Suicide Severity Rating Scale (C-SSRS),
• be on a stable psychiatric medication regimen for ≥28 days,
• maintain a treating doctor who is in agreement with study participation, and aware of the safety plan in the protocol,
• have a reliable chaperone accompany them home following the completion of the ketamine infusion day,
• be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),
• be of non-childbearing potential or use of an acceptable form of birth control (females only), and
• be right handed.
• Healthy Controls will:
• be ≥18 years old,
• read, understand, and provide written informed consent,
• have a negative pregnancy test on the morning of the MRI (females only).
• be right handed.

You may not qualify if:

• Patients will be excluded if any of the following criteria are met:
• delirium or dementia diagnosis,
• unstable medical illness or clinically significant laboratory results,
• history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects or alter brain morphology (e.g., diabetes, hypertension, traumatic brain injury), even if well controlled on medications,
• history of multiple adverse drug reactions,
• active substance use disorders (except nicotine and caffeine) within the past six months, positive urine toxicology screen, or past history of ketamine/PCP abuse,
• requirement of excluded medications that may interact with ketamine (e.g., narcotics, barbiturates, sedatives, theophylline, or St. John's Wort),
• BMI \>35,
• pregnancy, breastfeeding, or unacceptable means of birth control (females only)
• presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)),
• concurrent participation in other research studies.
• Healthy controls will be excluded if any of the following criteria are met:
• current or past Axis I diagnosis, including alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine) and suicidal thoughts/attempts,
• presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)),
• presence of medical illness likely to alter brain morphology and/or physiology (e.g., diabetes) even if controlled by medications,

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• MGH Depression Clinical and Research Program

MeSH Terms

Conditions

Suicidal Ideation; Suicide; Depression

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dawn Ionescu, M.D.

  MGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Psychiatry

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 25, 2015
• Study Start: February 1, 2017
• Primary Completion: February 1, 2017
• Study Completion: February 28, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

US (1)