NCT02299440.

Study name	Evaluation of the effects of ketamine in the acute phase of suicidal ideation: a multicenter randomized double‐blind trial
Methods	EXPERIMENTAL: Ketamine ‐ Patients randomised to this group will be treated via Ketamine infusion Intervention: Baseline evaluation Intervention: 1st perfusion of ketamine Intervention: Follow‐up between perfusions Intervention: 2nd perfusion of ketamine Intervention: Follow‐up after perfusions. Other: Baseline evaluation Before perfusions begin, each patient will have a baseline evaluation including the following: the Columbia Suicide Severity Rating Scale (CSSRS), the Beck Scale for Suicide Ideation (BSSI), a physical pain VAS (visual analogue scale), a mental pain VAS, the Clinical Global Impressions Scale (CGI‐S), Beck's Hopeless scale (BHS), the 16‐item Quick Inventory of Depressive Symptomatology (QIDS‐SR16), the Inventory of Depressive Symptomatology for the Clinician (IDS‐C30), the Patient Rated Inventory of Side Effects (PRISE), the Young Mania Rating Scale (YMRS), and the Brief Psychiatric Rating Scale (BPRS). Drug: 1st perfusion of ketamine A is performed: 0.5 mg/kg diluted in saline, administered over 40 minutes by intravenous (IV) pump and cardiorespiratory monitoring (Day 0). Other: Follow‐up between perfusions. Patients will be re‐evaluated with a selection of questionnaires at 40 minutes, 120 minutes, 4 hours, and 24 hours after the end of the first perfusion, and then again at 48 hours after the end of the first perfusion and right before the second perfusion. Drug: 2nd perfusion of ketamine A is performed: 0.5 mg/kg diluted in saline, administered over 40 minutes by intravenous (IV) pump and cardiorespiratory monitoring (Day 2). Other: Follow‐up after perfusions. Patients will be re‐evaluated with a selection of questionnaires at 40 minutes, 120 minutes, and 4 hours after the end of the second perfusion, and then again at Day 3, Day 4, Week 2, Week 4 and Week 6 COMPARATOR: Placebo/control (saline)
Participants	18 Years and older Inclusion criteria: French speaking patients freely hospitalised for prevention of suicide and who have a medium or high suicide risk score according to a MINI structured interview. The patient is able to understand how the study is carried out and the tests performed. The patient is deemed capable of giving his/her informed consent. The patient has been correctly informed. The patient must have given his/her informed and signed consent. The patient must be insured or beneficiary of a health insurance plan. Presence of suicidal ideation according to the SSI score (score > 3). Negative pregnancy test for women of childbearing age
Interventions	Ketamine versus placebo
Outcomes	Columbia Suicide Severity Rating Scale (CSSRS), the Beck Scale for Suicide Ideation (BSSI), a physical pain VAS (visual analogue scale), a mental pain VAS, the Clinical Global Impressions Scale (CGI‐S), Beck's Hopeless scale (BHS), the 16‐item Quick Inventory of Depressive Symptomatology (QIDS‐SR16), the Inventory of Depressive Symptomatology for the Clinician (IDS‐C30), the Patient Rated Inventory of Side Effects (PRISE), the Young Mania Rating Scale (YMRS) and the Brief Psychiatric Rating Scale (BPRS)
Starting date	April 2015
Contact information	Contact: Mocrane Abbar, MD
Notes	NCT02299440