Clinical TrialTreatment-Resistant Depression (TRD)KetaminePlaceboUnknown status

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

This study aims to 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).

Target Enrollment
88 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomized, quadruple-blind, parallel-group Phase IV trial comparing intramuscular ketamine (0.75 mg/kg IM three times weekly for 4 weeks, then weekly maintenance for 6 months) with IM saline plus oral escitalopram 15 mg and aripiprazole 5 mg in participants with treatment-resistant depression.

Primary outcome is antidepressant response in TRD; secondary outcomes include safety/tolerability (UKU-SERS, CADSS, BPRS-12), cognition, quality of life, and suicidal risk; vital signs monitored continuously for 2 hours after each injection.

Study Protocol

Preparation

sessions

Dosing

12 sessions
120 min each

Integration

sessions

Study Arms & Interventions

Ketamine IM

experimental

IM ketamine 0.75 mg/kg three times weekly for 4 weeks (12 initial injections) with weekly maintenance for 6 months; injections into gluteal muscle; 2 placebo tablets administered concomitantly.

Interventions

  • Ketamine0.75 mg/kg
    via IM• three times weekly then weekly maintenance• 12 doses total

    Injections into gluteal muscle; maintenance weekly for 6 months; observed for 2 hours after dosing.

Escitalopram + Aripiprazole

active comparator

IM saline (placebo) injections plus oral escitalopram 15 mg and aripiprazole 5 mg as active comparator.

Interventions

  • Placebo
    via IM• three times weekly then weekly maintenance• 12 doses total

    Saline IM injections matching ketamine schedule; observed for 2 hours after dosing.

  • Compound
    via Oral• daily

    Escitalopram 15 mg and aripiprazole 5 mg (oral) given as active comparator.

Participants

Ages
18 – 40
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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.

Study Details

Locations

Núcleo de Pesquisas em Saúde Mental — Blumenau, Santa Catarina, Brazil

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