Clinical TrialSuicidalityKetamineWithdrawn

The Impact of Ketamine on the Reward Circuitry of Suicidal Patients

The investigators propose to study the neurocircuitry of suicidal thoughts, regardless of whether or not depression is present.

Target Enrollment
Not specified
Study Type
Phase III interventional
Design
Non-randomized

Detailed Description

Open-label diagnostic Phase III study using a single ketamine infusion to probe reward-circuitry and suicidal ideation in patients and including healthy control comparisons; neuroimaging (MRI) endpoints collected.

Primary aim is to characterise the neurobiology of suicidal thoughts independent of depression; clinical safety screening, ECG and lab monitoring, and follow-up per protocol.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Open-Label Ketamine

experimental

Single open-label ketamine infusion (patients and healthy controls).

Interventions

  • Ketamine
    via IV• single dose

    Single open-label ketamine infusion; dose per protocol (not specified in registry fragment).

Participants

Ages
18 – 85
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:\n\nPatients will:\n\n1. be ≥18 years old,\n2. read, understand, and provide written informed consent,\n3. have suicidal ideation for ≥ 2 months, per the Columbia Suicide Severity Rating Scale (C-SSRS),\n4. be on a stable psychiatric medication regimen for ≥28 days,\n5. maintain a treating doctor who is in agreement with study participation, and aware of the safety plan in the protocol,\n6. have a reliable chaperone accompany them home following the completion of the ketamine infusion day,\n7. be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),\n8. be of non-childbearing potential or use of an acceptable form of birth control (females only), and\n9. be right handed.\n\nHealthy Controls will:\n\n1. be ≥18 years old,\n2. read, understand, and provide written informed consent,\n3. have a negative pregnancy test on the morning of the MRI (females only).\n4. be right handed.

Exclusion Criteria

  • Exclusion Criteria (Patients):\n\n1. delirium or dementia diagnosis,\n2. unstable medical illness or clinically significant laboratory results,\n3. 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,\n4. history of multiple adverse drug reactions,\n5. active substance use disorders (except nicotine and caffeine) within the past six months, positive urine toxicology screen, or past history of ketamine/PCP abuse,\n6. requirement of excluded medications that may interact with ketamine (e.g., narcotics, barbiturates, sedatives, theophylline, or St. John's Wort),\n7. BMI >35,\n8. pregnancy, breastfeeding, or unacceptable means of birth control (females only)\n9. presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)),\n10. concurrent participation in other research studies.\n\nHealthy controls exclusion:\n\n1. current or past Axis I diagnosis, including alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine) and suicidal thoughts/attempts,\n2. presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)),\n3. presence of medical illness likely to alter brain morphology and/or physiology (e.g., diabetes) even if controlled by medications,\n4. requirement of excluded medications that may interact with ketamine (e.g., narcotics, barbiturates, benzodiazepines, sedatives, theophylline, or St. John's Wort),\n5. presence of psychiatric disorders in first-degree relatives,\n6. pregnancy, breastfeeding, or unacceptable means of birth control (females only), or\n7. BMI >35.

Study Details

  • Status
    Withdrawn
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Non-randomized
    • 0
  • Timeline
    Start: 2017-02-01
    End: 2017-02-28
  • Compound
    Ketamine
  • Topic
    Suicidality

Locations

Massachusetts General Hospital — Boston, Massachusetts, United States

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