Major Depressive DisorderNCT05249309

Naturalistic Study of Ketamine in the Treatment of Depression

An observational study of Major Depressive Disorder and Bipolar Disorder, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Major Depressive Disorder, Bipolar Disorder, Bipolar Depression
What is being tested?: Ketamine
Type of treatment: Injection or infusion
How many people: 90 participants
Where: 2 sitesBrazil
Study dates: 1 May 2021to 15 Dec 2023
How long will I take part?: 6 Months
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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);
18 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;

Show all 11Show fewer

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-000
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903

Other trials in Brazil

About this study

Official title: Naturalistic Study of Ketamine in the Treatment of Depression: Suicide Risk Assessment and Serum Measurements of SIRT3, suPAR, hsCRP, Interleukin 6, Complete Blood Count, Leptin, Lipid Profile and Blood Glucose

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.

Read the detailed description

Mood disorders are chronic, recurrent, and highly prevalent health conditions worldwide. Major depression and bipolar disorder are often associated with psychosocial functional impairments and general medical conditions. Furthermore, suicide figures as one of the most important negative outcomes of mood disorders. In this sense, according to the World Health Organization (WHO), psychiatric disorders are associated with more than 90% of cases of complete suicide and are responsible for 30% of reported suicide cases worldwide. Suicide is a matter of concern for clinicians, not only because of the individual and familiar impact but also due to its social and population impact; then, research involving new potential treatments for suicide behavior ate highly needed.

The literature has shown that ketamine, a substance commonly used as an anesthetic, is effective in treating depressive symptoms. Considering the high rate of suicide among patients with mood disorders and its consequences, the aim of this naturalistic study is to investigate the effect of ketamine in reducing the risk of suicide in patients with a depressive episode. The hypothesis is that treatment with ketamine will result in an improvement in depressive symptoms as well as in a decrease in the risk of suicide.

Therefore, forty-five patients will be recruited, with major depressive disorder, bipolar I disorder or bipolar II disorder and who were already on ketamine treatment prescribed by assistant psychiatrist (inclusion criteria). Patients will go on the standard protocol of ketamine 0.5mg/kg subcutaneously (SC) twice a week for one month in general. In line with a naturalistic approach, all changes in the protocol, in time and doses will be accepted, according to the assistant doctor prescription without study intervention.

After this period, they could receive the same dose of the medication once a week for the third month. In addition, patients will be monitored by phone until month six.

Forty-five 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.

Conditions: Major Depressive Disorder, Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder, Affective Disorder
Being tested: Ketamine
Keywords: Ketamine, Suicide, Depression, Major depressive disorder, Major depression, Unipolar depression, Depressive disorders, Bipolar I disorder, Bipolar II disorder, Bipolar depression
Medical subject headings: Depressive Disorder, Major, Bipolar Disorder, Mood Disorders, Suicide, Depression, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KetamineDrug
Also called Ketalar
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.

Study groups in NCT05249309
Study group	Role	What they receive
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. Receives: Drug: Ketamine
Control		Will be checked weight, height and waist circumference and collected about 15 mL of peripheral blood.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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)
Change from baseline in HAMD score. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Measured: For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24
Change in psychotic symptoms according to Brief Psychiatric Rating Scale (BPRS)
Change from baseline in BPRS score. Scale range: from 0 to 108. Higher values represent more severe symptoms of psychosis.
Measured: For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24
Change in depressive symptoms according to Montgomery-Asberg Depression Rating Scale (MADRS)
MADRS is a 10-item rating scale for depressive mood symptoms severity, items rated on 0-6 scale, with total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Measured: 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)
Change from baseline in YMRS score. The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.
Measured: For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24
Change in functioning according to Functioning Assessment Short Test (FAST)
Change from baseline in FAST scores. The overall FAST score ranges from 0 to 72, where a higher score indicates more severe difficulties.
Measured: For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24
Change in SIRT3 levels in the blood.
Change in Sirtuin 3 levels in the blood
Measured: For Weeks 1 and 4
Change in suPAR levels in the blood.
Change in soluble urokinase-type plasminogen activator receptor levels in the blood
Measured: For Weeks 1 and 4
Change in hsCRP levels in the blood.
Change in sensitivity C-reactive protein levels in the blood
Measured: For Weeks 1 and 4
Change in IL-6 levels in the blood.
Change in interleukin 6 levels in the blood
Measured: For Weeks 1 and 4
Change in leptin levels in the blood.
Change in leptin levels in the blood.
Measured: For Weeks 1 and 4
Change in blood count.
Change in blood count.
Measured: For Weeks 1 and 4
Change in lipid profile levels in the blood.
Change in lipid profile levels in the blood.
Measured: For Weeks 1 and 4
Change in blood glucose levels.
Change in blood glucose levels.
Measured: For Weeks 1 and 4
Change in body weight
The measurement of body weight will be carried out with individuals barefoot, wearing as little clothing as possible and positioned in the center of the platform while reading. Electronic scale with maximum capacity of 150 kg and precision of 0.1 kg.
The weight will be measured in kilograms (kg).
Measured: For Weeks 1 and 4
Body height measurement
The measurement of body height will be performed with barefoot individuals. The height will be measured in meters (m).
Measured: For Weeks 1 and 4
Change in the Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m^2.
Measured: For Weeks 1 and 4
Change in waist circumference
The waist circumference (WC) will be measured with the aid of an inelastic measuring tape of 1.5 m in length and 0.1 cm accuracy. The measurement will be taken with the patient standing, in upright position, relaxed abdomen, arms extended along the body and feet apart in a distance of 25-30 cm. The midpoint between the iliac crest and the lower edge of the last rib, standing upright, with no clothes on the chest and at the end of expiration.
Measured: For Weeks 1 and 4
Change in blood pressure
Change in diastolic and systolic blood pressure during ketamine application
Measured: For Weeks 1, 2, 3 and 4
Change in IL-10 levels in the blood.
Change in interleukin 10 levels in the blood
Measured: For Weeks 1 and 4
Change in TNFalpha levels in the blood.
Change in TNFalpha levels in the blood
Measured: For Weeks 1 and 4
Change in the Dietary Inflammatory Index (DII)
The inflammatory index of the diet will be calculated from the average of dietary recalls in the last 24 hours (R24h) at the interview with intervals between them according to the application of ketamine.
A high DII score reflects pro-inflammatory potential of the diet, whereas a low DII score reflects the anti-inflammatory potential of the diet.
Measured: For Weeks 1 and 4
Changes in proteomic markers
Proteomic markers will be analyzed at weeks 1 and 4 to observe for any treatment-emergent changes to increase the predictive validity of the proteomic signatures.
Measured: For Weeks 1 and 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202115 Dec 2023

First posted21 Feb 2022
Study start1 May 2021
Primary completion1 Nov 2022
Study completion15 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 90 participants (estimated)
Target duration: 6 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT05249309
Sponsor's protocol ID: 2020-0334
Status last verified: Sep 2023
First submitted: 7 Dec 2021
Last updated: 25 Sep 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35503059
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.
PubMed 38688118
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.
PubMed 36970275

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Naturalistic Study of Ketamine in the Treatment of Depression: Suicide Risk Assessment and Serum Measurements of SIRT3, suPAR, hsCRP, Interleukin 6, Complete Blood Count, Leptin, Lipid Profile and Blood Glucose
ClinicalTrials.gov ID: NCT05249309
Acronym / sponsor ID: 2020-0334
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
Study type: Observational
Recruitment status: Unknown status
Enrolment: 90 participants (estimated)
Lead sponsor: Hospital de Clinicas de Porto AlegreUniversity, hospital or other
Collaborators: Federal University of Rio Grande do Sul, Hospital Moinhos de Vento
Study start: 1 May 2021 (actual)
Primary completion: 1 Nov 2022 (actual)
Study completion: 15 Dec 2023 (estimated)
First posted: 21 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

After this period, they could receive the same dose of the medication once a week for the third month. In addition, patients will be monitored by phone until month six.

Study design

Observational model: Other
Time perspective: Prospective
Target follow-up: 6 Months
Number of arms: 2

Arm	Type	Receives
Treatment	–	Drug: KetamineThe 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.
Control	–	–Will be checked weight, height and waist circumference and collected about 15 mL of peripheral blood.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (11 listed)

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);
18 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);

Key exclusion criteria (7 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KetamineAlso: KetalarThe 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	Treatment

Primary outcome

Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity
Time frame: For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24
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.
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior
Time frame: For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24
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.

22 secondary outcomes

Change in depressive symptoms according to Hamilton Depression Rating Scale (HAMD)
Time frame: For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24
Change in psychotic symptoms according to Brief Psychiatric Rating Scale (BPRS)
Time frame: For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24
Change in depressive symptoms according to Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 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)
Time frame: For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24
Change in functioning according to Functioning Assessment Short Test (FAST)
Time frame: For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24
Change in SIRT3 levels in the blood.
Time frame: For Weeks 1 and 4
Change in suPAR levels in the blood.
Time frame: For Weeks 1 and 4
Change in hsCRP levels in the blood.
Time frame: For Weeks 1 and 4
Change in IL-6 levels in the blood.
Time frame: For Weeks 1 and 4
Change in leptin levels in the blood.
Time frame: For Weeks 1 and 4
Change in blood count.
Time frame: For Weeks 1 and 4
Change in lipid profile levels in the blood.
Time frame: For Weeks 1 and 4
Change in blood glucose levels.
Time frame: For Weeks 1 and 4
Change in body weight
Time frame: For Weeks 1 and 4
Body height measurement
Time frame: For Weeks 1 and 4
Change in the Body Mass Index (BMI)
Time frame: For Weeks 1 and 4
Change in waist circumference
Time frame: For Weeks 1 and 4
Change in blood pressure
Time frame: For Weeks 1, 2, 3 and 4
Change in IL-10 levels in the blood.
Time frame: For Weeks 1 and 4
Change in TNFalpha levels in the blood.
Time frame: For Weeks 1 and 4
Change in the Dietary Inflammatory Index (DII)
Time frame: For Weeks 1 and 4
Changes in proteomic markers
Time frame: For Weeks 1 and 4

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
Results publication: PubMed 35503059Cordova 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.
Derived from this study: PubMed 38688118Anzolin 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.
Derived from this study: PubMed 36970275Anzolin 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ana P Anzolin, Master study chair

Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

Keila Maria M Ceresér, PhD study chair

Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

Jéferson F Goularte, PhD study chair

Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Major Depressive Disorder and Bipolar Disorder, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity (time frame: For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05249309, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.