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VA Aripiprazole vs Esketamine for Treatment Resistant Depression

NCT05554627 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-01-05

No results posted yet for this study

Summary

This is an open-label, parallel-group, randomized clinical trial of up to 6 months treatment of adjunctive intranasal (IN) esketamine (ESK) vs. adjunctive aripiprazole (ARI) in Veterans with unipolar Treatment Resistant Depression (TRD). This study will assess the efficacy, safety, and acceptability of adjunctive IN ESK in comparison to ARI, one of the best studied and most widely used adjunctive therapies for TRD. The primary hypothesis is that participants receiving adjunctive IN ESK will be significantly more likely to achieve remission after six weeks of treatment as compared to those who receive adjunctive ARI. Depressive symptoms will be assessed by central raters (CR), blinded to treatment assignment, using the clinician rated version of the Quick Inventory of Depressive Symptomatology (QIDS-C16), a well-validated tool that is commonly used and is easily translated across other depression inventory scales. The study is powered to detect an absolute difference in remission rates of 10%, or larger, at 6 weeks. Additional outcomes of interest include symptom reduction across 6 months of randomized therapy, side effects and other tolerability indices, attrition rates and measures of quality of life and cost-effectiveness.

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Esketamine

Intranasal spray; a dissociative hallucinogen drug used as a general anesthetic and an antidepressant for treatment of depression.

DRUG

Aripiprazole

Atypical antipsychotic; used in the treatment of schizophrenia and bipolar disorder. Other uses include as an add-on treatment in major depressive disorder, tic disorders and irritability associated with autism. Taken by mouth or injection into a muscle.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Somaia Mohamed, PhD · VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-27
Primary Completion
2023-10-27
Completion
2023-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05554627 on ClinicalTrials.gov