Effects of Ketamine in the Acute Phase of Suicidal Ideation

PHASE3CompletedINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

March 12, 2019

Study Completion Date

March 26, 2019

Conditions
Suicidal Ideation
Interventions
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 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).

DRUG

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)

DRUG

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)

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 and then again Day 3, Day 4, Week 2, Week 4 and Week 6.

DRUG

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)

DRUG

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)

Trial Locations (9)

30000

Clinique Les Sophoras, Nîmes

30029

CHRU de Nîmes - Hôpital Universitaire Carémeau, Nîmes

34295

CHRU de Montpellier - Hôpital Lapeyronie, Montpellier

37540

CHRU de Tours - Clinique Psychiatrique Universitaire, Saint-Cyr-sur-Loire

59037

CHRU de Lille - Hôpital Michel Fontan, Lille

63003

CHU de Clermont Ferrand - Hôpital Gabriel-Montpied, Clermont-Ferrand

75010

APHP - Hôpital Lariboisière, Paris

75674

Centre Hospitalier Sainte-Anne, Paris

CMME Centre Hospitalier Sainte Anne, Paris

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Nīmes

OTHER

NCT02299440 - Effects of Ketamine in the Acute Phase of Suicidal Ideation | Biotech Hunter | Biotech Hunter