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Evaluation of the use of ketamine medication in the treatment of depressed or bipolar people: a study with a control group

Sublingual ketamine in the treatment of Mood Disorders

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6tzs5k
Enrollment
Unknown
Registered
2018-12-15
Start date
2018-04-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive episode unspecified, Bipolar affective disorder unspecified

Interventions

Open and controlled clinical trial involving 60 participants, 30 of whom were active and 30 of the control group to evaluate the adjuvant effect of ketamine. Participants will start with a dose of 0.4
Drug

Sponsors

Hospital São José
Lead Sponsor
Hospital São José
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Volunteers who have some mood disorder and high risk of suicide; age from 14 to 74 years of age

Exclusion criteria

Exclusion criteria: Volunteers manifesting delusions or manic symptoms upon examination of mental state or by BPRS and / or YOUNG; present substance use disorder with recent use in the last 72 hours (except nicotine and benzodiazepines) or present severe exogenous intoxication; being pregnant or with suspected pregnancy

Design outcomes

Primary

MeasureTime frame
Reduction of the depressive symptoms during the intervention period (maximum of 14 days) verified by the Montgomery Asberg Depression Rating Scale (MADRS) from the observation of the reduction of at least 50% in the pre and post intervention measurements

Secondary

MeasureTime frame
Remission of suicidal ideation during the intervention period (maximum of 14 days) verified through item 10 of the MADRS instrument from the observation of the total remission (zero value) in the post-intervention measurement, using the pre-intervention measurement as the baseline

Countries

Brazil

Contacts

Public ContactRafael de Araújo

Hospital São José

rmpsiquiatria@gmail.com+55 (51) 3716 1219

Outcome results

None listed

Source: REBEC (via WHO ICTRP)