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

U

University of Sao Paulo

Status and phase

Unknown
Phase 4

Conditions

Depressive Disorder

Treatments

Other: Quality of life and disability
Device: Safety of ketamine IM
Other: Suicide risk
Drug: Ketamine
Diagnostic Test: Cognition
Other: Depression thoughts
Other: Clinical and epidemiological factors
Other: Tolerability of ketamine IM

Study type

Interventional

Funder types

Other

Identifiers

NCT04234776
rampty2805

Details and patient eligibility

About

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.

Full description

Compare the response of ketamine IM versus active control in treatment-resistant depression (TRD [primary outcome]) and find safety and tolerability of ketamine IM, evaluate changes in life quality, cognition and suicidal risk (secondary outcomes)

Enrollment

88 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of TRD, according to clinical evaluation and confirmed by SCID-IV (Structured Clinical Interview for the DSM);
  • Moderate to severe intensity of the disease;

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,

  • Literate and able to understand the tasks requested;
  • With clinical comorbidities, however compensated;
  • Patients and/or legal representatives should understand the nature of the study and sign the Informed Consent Form.

Exclusion criteria

  • Imminent risk of suicide;
  • Patients with psychoactive substance dependence;
  • Intellectual deficit and psychotic symptoms;
  • Bipolar spectrum disorders and other primary psychiatric diagnoses;
  • Allergic to ketamine;
  • Glaucoma;
  • Treatment with reversible MAOI (monoamine oxidase inhibitor) in the week prior to visit 0;
  • Treatment with irreversible MAOI in two weeks prior to visit 0;
  • Fluoxetine treatment within 4 weeks prior to visit 0;
  • Treatment with others antidepressants;

Treatment with antipsychotics, lithium, benzodiazepines or other psychotropic drugs within 7 days prior to visit 0;

a. Lorazepam and zolpidem may be used;

Patients who become pregnant will be excluded from the study and referred for obstetric care.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

88 participants in 2 patient groups

Rapid-acting antidepressant
Experimental group
Description:
Subjects eligible to participate in the study will receive IM ketamine and will use 2 placebo tablets as randomized.
Treatment:
Other: Tolerability of ketamine IM
Other: Clinical and epidemiological factors
Other: Depression thoughts
Diagnostic Test: Cognition
Drug: Ketamine
Device: Safety of ketamine IM
Other: Suicide risk
Other: Quality of life and disability
Comparator
Active Comparator group
Description:
Subjects eligible to participate in the study will receive IM saline and will use escitalopram 15 mg and aripiprazole 5 mg as randomized
Treatment:
Other: Tolerability of ketamine IM
Other: Clinical and epidemiological factors
Other: Depression thoughts
Diagnostic Test: Cognition
Drug: Ketamine
Device: Safety of ketamine IM
Other: Suicide risk
Other: Quality of life and disability

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems