Status:
COMPLETED
Ketamine For Suicidal Ideation
Lead Sponsor:
James Murrough
Conditions:
Suicidal Ideation
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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).
Detailed Description
Depression is a debilitating disorder that affects 12-20% of population and is among the top five leading causes of burden of disease worldwide (Kruijshaar ME 2005). Suicide associated with depression...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01507181
Start Date
January 1 2012
End Date
September 1 2014
Last Update
February 8 2017
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10027