Phase 4
N=24
Ketamine For Suicidal Ideation
Suicidal Ideation
Bottom Line
View on ClinicalTrials.gov: NCT01507181 ↗Enrolled (actual)
24
Serious AEs
20.8%
Results posted
Feb 2017
Primary outcome: Primary: Change in Beck Scale for Suicidal Ideation (BSSI) — 10.8; 14.0 units on a scale — p=0.32
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketamine (Drug); Midazolam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- James Murrough
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Beck Scale for Suicidal Ideation (BSSI) |
8.8; 15.3 | 0.047 sig |
| PRIMARY Change in Beck Scale for Suicidal Ideation (BSSI) |
8.8; 15.3 | 0.047 sig |
| SECONDARY Montgomery-Asberg Depression Rating Scale (MADRS) |
19.0; 26.2; 19.3; 28; 20.9; 24.1 | 0.17 |
| SECONDARY Suicidality Item of the MADRS (MADRS-SI) |
1.8; 3.3 | — |
| SECONDARY The Young Mania Rating Scale (YMRS) |
0.0; 0.1; 0.0; 0.3; 0.2; 0.2 | — |
| SECONDARY The Brief Psychiatric Rating Scale (BPRS) |
7.7; 7.7; 9.9; 7.9; 8.1; 7.0 | — |
| SECONDARY The Clinician-Administered Dissociative States Scale (CADSS) |
1.1; 4.0; 17.1; 3.3; 1.2; 1.3 | — |
| SECONDARY Patient Rated Inventory of Side Effects (PRISE) |
29; 23 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT01507181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.