Naturalistic Study of Ketamine in the Treatment of Depression

Summary

This study aims to examine the effect of ketamine in decreasing the risk of suicide in patients with depression and its effectiveness as an antidepressant agent.

Conditions

• Major Depressive Disorder
• Bipolar Disorder
• Bipolar Depression
• Bipolar I Disorder
• Bipolar II Disorder
• Affective Disorder

Interventions

DRUG

Ketamine

The administration will be done subcutaneously, in the abdominal wall, using ketamine without dilution. The ketamine dose will be 0.5mg/kg, recommended for the first infusion. If there is no adequate response, according to psychiatric scales and clinical evaluation, the second infusion must be performed at least two days after the first, using 0.75mg/kg and the subsequent 1mg/kg. If the patient adequately responds to a dose (0.5 or 0.75mg/kg), it should be repeated after over twice weekly over a period of 4 weeks.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul

  collaborator OTHER

• Hospital Moinhos de Vento

  collaborator OTHER

• Hospital de Clinicas de Porto Alegre

  lead OTHER

Principal Investigators

• Ana P Anzolin, Master · Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

• Keila Maria M Ceresér, PhD · Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

• Jéferson F Goularte, PhD · Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

• Jairo Vinícius Pinto, MD, PhD · Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

• Paulo B de Abreu, MD, PhD · Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

• Ives C Passos, MD, PhD · Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

• Márcia K Sant'Anna, MD, PhD · Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

• Ellen Scotton, Master · Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

• Luciane N Cruz, MD, PhD · Hospital Moinhos de Vento

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-01

Primary Completion

2022-11-01

Completion

2023-12-15

Countries

• Brazil

Study Locations