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CompletedPhase 4Results posted

Ketamine For Suicidal Ideation

NCT01507181 · James Murrough

Closed to entry
Status
Not accepting participants
Phase 4
Phase
24
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

This study will examine the effects of Intravenous (IV) ketamine both in an outpatient population and with subjects on the inpatient unit with suicidal ideation (SI).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Beck Scale for Suicidal Ideation (BSSI)

    Measured over baseline and 24 hours post infusion

  • Change in Beck Scale for Suicidal Ideation (BSSI)

    Measured over baseline and 48 hours post infusion

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 80 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * English speaking Male or female patients, 18-80 years * Patients have voluntarily admitted themselves to an inpatient psychiatric unit at MSH or, regarding the outpatient population, have clinically significant suicidal ideation without intent to harm themselves * Women of childbearing potential must have a negative pregnancy test * Clinically significant suicidal ideation and score of ≥4 on MADRS item 10 for suicidality * Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document Exclusion Criteria: * Lifetime history of schizophrenia or other primary psychotic disorder * Current presence of psychotic symptoms * Lifetime history of a clearly established psychotic episode * Established diagnosis of Schizoid, Schizotypal or Paranoid personality disorder * Urine toxicology screen positive for drugs of abuse on admission * Substance abuse or dependence within the preceding 1 month * Anticipated discharge within 7 days of study enrollment (for patients in the inpatient arm) * Women who plan to become pregnant, are pregnant or are breast-feeding * Concurrent course of electroconvulsive therapy (ECT) * Any unstable medical illness including hepatic, renal, gastro-enterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease * Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG * The presence of any known or suspected contraindications to midazolam or ketamine including, but not limited to, known allergic reactions to these agents or acute intermittent porphyria * Uncontrolled hypertension, defined as BP systolic \>160 or BP diastolic \>100 on medications * Arrhythmia requiring medication * Severe coronary artery disease, defined as Canadian Cardiovascular Status III or IV

Where

1 study site

FacilityCityRegionCountry
Icahn School of Medicine at Mount SinaiNew YorkNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT01507181 on ClinicalTrials.gov →

Last updated in the registry 2017-02-08. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits