Intramuscular Ketamine Versus Aripiprazole and... — Clinical Trial Details

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.

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.

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

Ketamine IM

Interventions

Escitalopram + Aripiprazole

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators