156
Participants
Start Date
April 30, 2015
Primary Completion Date
March 12, 2019
Study Completion Date
March 26, 2019
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 analog scale), a mental pain VAS, the Clinical Global Impressions Scale (CGI-S), Beck's Hopeless scale (BHS), 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).
1st perfusion of ketamine
A 1st perfusion of ketamine is performed: 0.5 mg/kg diluted in saline, administered over 40 minutes by intravenous (IV) pump and cardiorespiratory monitoring. (Day 0)
1st perfusion of saline
A 1st perfusion of saline is performed: the same volume of saline as in the ketamine arm, administered over 40 minutes by IV pump and cardiorespiratory monitoring. (Day 0)
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 and then again Day 3, Day 4, Week 2, Week 4 and Week 6.
2nd perfusion of ketamine
A 2nd perfusion of ketamine is performed: 0.5 mg/kg diluted in saline, administered over 40 minutes by intravenous (IV) pump and cardiorespiratory monitoring. (Day 2)
2nd perfusion of saline
A 2nd perfusion of saline is performed: the same volume of saline as in the ketamine arm, administered over 40 minutes by IV pump and cardiorespiratory monitoring. (Day 2)
Clinique Les Sophoras, Nîmes
CHRU de Nîmes - Hôpital Universitaire Carémeau, Nîmes
CHRU de Montpellier - Hôpital Lapeyronie, Montpellier
CHRU de Tours - Clinique Psychiatrique Universitaire, Saint-Cyr-sur-Loire
CHRU de Lille - Hôpital Michel Fontan, Lille
CHU de Clermont Ferrand - Hôpital Gabriel-Montpied, Clermont-Ferrand
APHP - Hôpital Lariboisière, Paris
Centre Hospitalier Sainte-Anne, Paris
CMME Centre Hospitalier Sainte Anne, Paris
Centre Hospitalier Universitaire de Nīmes
OTHER