CompletedPhase 4ketamine
Ketamine For Suicidal Ideation
Sponsored by James Murrough
NCT ID
NCT01507181
Target Enrollment
24 participants
Start Date
2012-01
Est. Completion
2014-09
About This Study
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).
Conditions Studied
Interventions
- •Ketamine
- •Midazolam
Eligibility
Age:18 Years - 80 Years
Healthy Volunteers:No
View full eligibility criteria
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
Study Locations (1)
Icahn School of Medicine at Mount Sinai
New York, New York, United States