Naturalistic Study of Ketamine in the Treatment of Depression

NCT05249309 | Unknown

• 1 other identifier: 2020-0334
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Ketamine; Suicide; Depression; Major depressive disorder; Major depression; Unipolar depression; Depressive disorders; Bipolar I disorder; Bipolar II disorder; Bipolar depression

Outcome Measures

Primary Outcomes (2)

• Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity

  Intensity of ideation was measured using the C-SSRS for Suicide Ideation intensity of ideation item. Item responses range from 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), with higher scores indicating more severe ideation.

  For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24

• Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior

  Items measuring attempt behavior (number of Actual Attempts, number of Aborted Attempts, number of Interrupted Attempts) From the C-SSRS were summed to create a composite variable indexing attempt behavior. Higher scores indicate more attempt behavior.

  For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24

Secondary Outcomes (22)

• Change in depressive symptoms according to Hamilton Depression Rating Scale (HAMD)

  For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24

• Change in psychotic symptoms according to Brief Psychiatric Rating Scale (BPRS)

  For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24

• Change in depressive symptoms according to Montgomery-Asberg Depression Rating Scale (MADRS)

  For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24

• Change in remission of manic symptoms according to Young Mania Rating Scale (YMRS)

  For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24

• Change in functioning according to Functioning Assessment Short Test (FAST)

  For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24

Study Arms (2)

Treatment

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.

Drug: Ketamine

Control

Will be checked weight, height and waist circumference and collected about 15 mL of peripheral blood.

Interventions

Ketamine DRUG

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.

Also known as: Ketalar

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Forty-five patients who fulfill the DSM-5 criteria for either MDD, Bipolar I disorder, or Bipolar II disorder who are currently in depressive episodes according to the structured clinical interview of the MINI. All participants must have been referred to receive ketamine for the treatment of a depressive episode at the Hospital de Clinicas de Porto Alegre (HCPA) and Hospital Moinhos de Vento (HMV). Forty-fiver participants without any personal or first-degree family history of psychiatry or neurologic disorders will be recruited to participate as controls. Biochemical analyses will be used to investigate inflammatory markers, transcription factors and other peripheral biomarkers in patients with mood disorders and healthy controls

You may qualify if:

• Having a diagnosis according to DSM-5 for
• Major depressive episode as part of either Major depressive disorder, Bipolar I disorder, or Bipolar II disorder according to Fifth Edition of Diagnostic and Statistical Manual for Mental Disorders (DSM-5);
• years old or older;
• Be able to provide written informed consent.episode;
• MADRS scale total score ≥ 12 and score in items 1 (apparent sadness) and 2 (expressed sadness) ≥ 2 during the screening period (baseline);
• YMRS scale total score ≤ 11 at baseline;
• Having current symptoms of suicidal ideation and/or behavior, according to the C-SSRS scores;
• Use of effective contraceptive methods in the case of heterosexual women of childbearing age;
• Indication/prescription of the attending physician for the use of ketamine, subcutaneous;
• For the patients with Bipolar I disorder: currently using lithium, valproic acid, or atypical antipsychotic at therapeutic doses for at least four weeks prior to initial evaluation.
• For patients with Bipolar II disorder: currently using lithium, valproic acid, lamotrigine, or atypical antipsychotic at therapeutic doses for at least four weeks prior to initial evaluation.

You may not qualify if:

• Patients with an unstable, defined, or suspected systemic medical condition;
• Women who are pregnant, breastfeeding or planning to become pregnant within the next year;
• Patients who cannot tolerate the use of ketamine or who have previous adverse effects associated with ketamine;
• Inability to comply with informed consent or treatment protocol needs;
• Patients currently with psychotic symptoms (according to DSM-5 criteria);
• Patients with a current diagnosis of any active substance use disorder according to the MINI/DSM-5 criteria (with the exception of tobacco);
• Patients with autoimmune or inflammatory conditions, cancer or active infectious diseases.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator
• Hospital Moinhos de Vento: collaborator

Study Sites (2)

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-000, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (3)

• Cordova VHS, Anzolin AP, Sant'Ana MK, Lacerda A, Belmonte-de-Abreu PS. Allergic reaction induced by subcutaneous administration of ketamine: a case report. Int Clin Psychopharmacol. 2022 Sep 1;37(5):229-230. doi: 10.1097/YIC.0000000000000411. Epub 2022 May 2.

  PMID: 35503059 RESULT

• Anzolin AP, Baldez DP, Montezano BB, Kapczinski F, de Abreu PB, Kauer-Sant'Anna M. Subcutaneous ketamine reduces suicide risk and improves functioning in depression: A proof-of-concept study. Psychiatry Res. 2024 Jul;337:115915. doi: 10.1016/j.psychres.2024.115915. Epub 2024 Apr 20.

  PMID: 38688118 DERIVED

• Anzolin AP, Goularte JF, Pinto JV, Belmonte-de-Abreu P, Cruz LN, Cordova VHS, Magalhaes LS, Rosa AR, Cereser KM, Kauer-Sant'Anna M. Ketamine study: Protocol for naturalistic prospective multicenter study on subcutaneous ketamine infusion in depressed patients with active suicidal ideation. Front Psychiatry. 2023 Mar 9;14:1147298. doi: 10.3389/fpsyt.2023.1147298. eCollection 2023.

  PMID: 36970275 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The types of biospecimens to be retained (plasma and serum).

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Mood Disorders; Suicide; Depression; Depressive Disorder

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Mental Disorders; Bipolar and Related Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ana P Anzolin, Master

  Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

• Keila Maria M Ceresér, PhD

  Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

• Jéferson F Goularte, PhD

  Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

• Jairo Vinícius Pinto, MD, PhD

  Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

• Paulo B de Abreu, MD, PhD

  Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

• Ives C Passos, MD, PhD

  Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

• Márcia K Sant'Anna, MD, PhD

  Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

• Ellen Scotton, Master

  Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

• Luciane N Cruz, MD, PhD

  Hospital Moinhos de Vento

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: February 21, 2022
• Study Start: May 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 15, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)