Unknown statusPhase 4

Intramuscular Ketamine Versus Aripiprazole and Escitalopram in the Treatment of Resistant Depression

NCT04234776 · KETProject · University of Sao Paulo

Closed to entry

Status

Not accepting participants

Phase 4

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

The treatment of resistant depression should be optimized aiming at complete remission of symptoms, a complex condition due to several factors. Approximately 1/3 of patients with depressive disorders do not even respond to available antidepressants. Consequently, new molecules with robust action, fast effects and sustained improvement are currently being researched worldwide. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has emerged as a promising alternative due to its involvement in neurogenesis, synaptogenesis and consequent rapid improvement of depressive and suicidal symptoms with traditional intravenous (IV) use in sub dose (0.5 mg / kg). The therapeutic response of IV use has been short and requires monitoring in a hospital setting. There are no studies evaluating response to long-term ketamine use. Recent research has focused on identifying other routes of ketamine use such as intranasal and intramuscular (IM). The use of ketamine IM, despite the fact that there are few studies and small samples, can demonstrate efficacy in acute treatment and maintenance of depression, as well as low profile of side effects, greater accessibility potential, reduced costs and risks, patient comfort and possible expansion of resistant depression treatment capabilities in different settings.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Change in depressive symptoms
Measured over 3 times a week in once month (Phase II)
Change in depressive symptoms
Measured over Once a week in six months (Phase III)
Change in depressive symptoms
Measured over Once a week in once month (Phase IV)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 40 Years

Ages

All

Sex

Not accepted

Healthy volunteers

Inclusion Criteria: 1. Diagnosis of TRD, according to clinical evaluation and confirmed by SCID-IV (Structured Clinical Interview for the DSM); 2. Moderate to severe intensity of the disease; 3. Female patients in fertile conditions should be using a clinically accepted contraceptive method (oral contraceptive and/or condom); a. Blood test will be requested at the diagnostic stage and in case of clinical doubt as to the patient's gestational status, 4. Literate and able to understand the tasks requested; 5. With clinical comorbidities, however compensated; 6. Patients and/or legal representatives should understand the nature of the study and sign the Informed Consent Form. Exclusion Criteria: 1. Imminent risk of suicide; 2. Patients with psychoactive substance dependence; 3. Intellectual deficit and psychotic symptoms; 4. Bipolar spectrum disorders and other primary psychiatric diagnoses; 5. Allergic to ketamine; 6. Glaucoma; 7. Treatment with reversible MAOI (monoamine oxidase inhibitor) in the week prior to visit 0; 8. Treatment with irreversible MAOI in two weeks prior to visit 0; 9. Fluoxetine treatment within 4 weeks prior to visit 0; 10. Treatment with others antidepressants; 11. Treatment with antipsychotics, lithium, benzodiazepines or other psychotropic drugs within 7 days prior to visit 0; a. Lorazepam and zolpidem may be used; 12. Patients who become pregnant will be excluded from the study and referred for obstetric care.

Where

1 study site

Facility	City	Region	Country
Núcleo de Pesquisas em Saúde Mental	Blumenau	Santa Catarina	Brazil

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT04234776 on ClinicalTrials.gov →

Last updated in the registry 2020-01-21. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Indication

Depressive Disorder21

All 8 trials from University of Sao Paulo →