Clinical trial to evaluate the use of the medication Esketamine with intravenous administration in association with the treatment of patients with severe depression who present with hallucinations and delusions

Phase 2

Recruiting

• Conditions: Severe depressive episode with psychotic symptoms; F32.3

• Registration Number: RBR-4n5f5jb
• Lead Sponsor: niversidade Federal da Bahia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-14
• Last Update Posted: 29 May 2023
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patient aged between 18 and 65 years, diagnosed with unipolar depression with psychotic symptoms, according to clinical evaluation and diagnostic criteria for unipolar depression of the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5), evaluated using MINI 7.0.2 (The Mini International Neuropsychiatric Interview), with a score of 20 or more on the MADRS scale at baseline; The assessment of psychotic symptomatology will be performed using item 15 of the BPRS, including patients with scores greater than or equal to 3 (i.e., without belief change after reality testing); The duration of the current depressive episode must be at least 4 weeks.

Exclusion Criteria

Patients diagnosed with primary psychotic disorders - such as schizophrenia, schizoaffective disorder, brief psychotic disorder - will be excluded, as well as patients with bipolar affective disorder, current substance use disorder according to DSM-5 criteria; patients in a state of mutism or catatonic stupor; patients with dementia or intellectual disability; pregnant or lactating patients; patients with uncompensated general medical conditions or general medical conditions whose psychotic and/or depressive symptoms may be a direct manifestation; and first-degree family members of investigators. Furthermore, patients with depressive symptoms attributed mostly to other psychiatric diagnoses other than MDD will be excluded, as in the case of patients with severe personality disorders; Patients undergoing treatment with electroconvulsive therapy (ECT) in the current episode will also be excluded; Hypertensive patients who are decompensated and refractory to antihypertensive measures at pre-infusion times will be excluded.

Study & Design

• Study Type: Intervention
• Study Design: Not specified