major depressive disorder, bipolar disorder, suicide risk
Conditions
Interventions
Our strategy will be to start with a very low dose (0.3 ml) of racemic ketamine 50 mg/ml (i.e. 15 mg) administered sublingually, allowed to absorb for 5 min and swallowed. Then we considered the inter
Drug
Sponsors
Hospital São José
Hospital São José
Eligibility
Age
16 Months to 59 Years
Inclusion criteria
Inclusion criteria: Volunteers who have any mood disorders and high risk of suicide; 16-59 years old.
Exclusion criteria
Exclusion criteria: Volunteers manifesting delusions or maniac symptoms to mental status examination or BPRS; an actual history of alcohol or substance dependence with recent use in the last 7 days except nicotine and benzodiazepines; an unstable or untreated medical disorder; severe exogenous intoxication; being pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of the depressive symptoms during the intervention period (maximum 14 days) assessed by the instrument Montgomery Asberg Depression Rating Scale (MADRS) from the reduction of at least 50% in pre and post-intervention measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of suicidal ideation during the intervention period (maximum 14 days) assessed by the instrument Beck Scale for Suicide Ideation (BSI) from the reduction of at least 50% in pre and post-intervention measurements. | — |
Countries
Brazil
Contacts
Public ContactRafael;Rafael Araújo;de Araújo
Hospital São José;Hospital São José
Outcome results
None listed