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Atypical Antipsychotic

Escitalopram + Brexpiprazole for Depression (CAN-BIND-17 Trial)

Phase 4

Recruiting

Led By Rudolf Uher, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Outpatients 18 to 60 years of age.

18 to 60 years of age.

Must not have

Failure of 4 or more adequate pharmacologic interventions (as determined by the Antidepressant Treatment History Form).

Patients who have previously failed escitalopram or showed intolerance to escitalopram or brexpiprazole, and patients at risk for hypomanic switch (i.e. with a history of antidepressant induced hypomania).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 8 and week 8 to week 12

Awards & highlights

All Individual Drugs Already Approved

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will test a predictive biomarker algorithm to help predict treatment outcome for patients with major depressive episodes. The algorithm uses data from previous studies on clinical features, imaging, EEG, and molecular information.

Who is the study for?

The OPTIMUM-D trial is for adults aged 18-60 with major depressive disorder (MDD) and a current major depressive episode (MDE). Participants must have a moderate to severe depression score, no significant mental or physical health issues, not be on psychotropic meds recently, speak English fluently, and have had the episode for at least 3 months. Excluded are those with bipolar disorder, unstable conditions, pregnancy/breastfeeding women, multiple failed depression treatments, recent psychotherapy starters or intolerance to study drugs.

What is being tested?

This trial tests whether data from clinical assessments, brain scans (imaging), EEGs (brain wave tests), and molecular studies can predict how well patients will respond to two antidepressants: Escitalopram or Brexpiprazole. It's conducted across eight sites using an algorithm developed from previous research.

What are the potential side effects?

Escitalopram may cause nausea, sleepiness or insomnia, weight changes and sexual dysfunction. Brexpiprazole might lead to similar side effects including restlessness and movement disorders. Both medications could potentially increase suicidal thoughts especially in young adults.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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I am between 18 and 60 years old.

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I don't have significant mental health issues or conditions like arthritis.

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I have been diagnosed with major depression.

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My condition has lasted for 3 months or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have tried 4 or more different depression medications without success.

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I had issues with escitalopram or brexpiprazole, or antidepressants caused me to become overly energetic.

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I have been diagnosed with Bipolar I or II.

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My main diagnosis is not major depressive disorder.

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I do not have any major neurological disorders or recent severe head injuries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 8 and week 8 to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 8 and week 8 to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 8 and week 8 to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline

Secondary study objectives

Clinical response

Remission at Week 8

Time to clinical response

Other study objectives

Week 12 clinical outcome - Remission

Week 12 clinical outcome - Response

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Random Allocation; Escitalopram + BrexpiprazoleActive Control2 Interventions

Patients are randomly assigned to the Random Allocation group and then randomly assigned to receive open-label escitalopram (10-20 mg/d) and blinded brexpiprazole (0.5-2 mg/d) for the first 8 weeks of the study. For the final 4 weeks of the study, patients will continue to receive both medications but the brexpiprazole will no longer be blinded.

Group II: Allocation by Predictive Biomarker Algorithm; Escitalopram + BrexpiprazoleActive Control2 Interventions

Patients are randomly assigned to the Allocation by Predictive Biomarker Algorithm group. Based on the outcome result from the personalized predictive biomarker algorithm, patients predicted as non-responders to escitalopram monotherapy will receive open-label escitalopram (10-20 mg/d) and blinded brexpiprazole (0.5-2 mg/d) for the first 8 weeks of the study. For the final 4 weeks of the study, patients will continue to receive both medications but the brexpiprazole will no longer be blinded.

Group III: Allocation by Predictive Biomarker Algorithm; PlaceboPlacebo Group1 Intervention

Patients are randomly assigned to the Allocation by Predictive Biomarker Algorithm group. Based on the outcome result from the personalized predictive biomarker algorithm, patients predicted to respond to escitalopram monotherapy will receive open-label escitalopram (10-20 mg/d) and blinded placebo for the first 8 weeks of the study. For the final 4 weeks of the study, responders will continue to receive open-label escitalopram without the placebo and non-responders will receive a combination of open-label escitalopram and open-label brexpiprazole.

Group IV: Random Allocation; PlaceboPlacebo Group1 Intervention

Patients are randomly assigned to the Random Allocation group and then randomly assigned to receive open-label escitalopram (10-20 mg/d) and blinded placebo for the first 8 weeks of the study. For the final 4 weeks of the study, responders will continue to receive open-label escitalopram without the placebo and non-responders will receive a combination of open-label escitalopram and open-label brexpiprazole.

0 / 10Eligibility criteria met