Ketamine For Suicidal Ideation

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: James Murrough
• Treatments: Excitatory Amino Acid Antagonists; Ketamine; Midazolam; N-Methylaspartate

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