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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 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.

Find a Location

Who is running the clinical trial?

BaycrestOTHER
44 Previous Clinical Trials
6,065 Total Patients Enrolled
2 Trials studying Depression
7 Patients Enrolled for Depression
University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
503,922 Total Patients Enrolled
55 Trials studying Depression
10,947 Patients Enrolled for Depression
Unity Health TorontoOTHER
562 Previous Clinical Trials
453,488 Total Patients Enrolled
18 Trials studying Depression
2,905 Patients Enrolled for Depression
University of British ColumbiaOTHER
1,481 Previous Clinical Trials
2,494,516 Total Patients Enrolled
43 Trials studying Depression
12,892 Patients Enrolled for Depression
Simon Fraser UniversityOTHER
57 Previous Clinical Trials
10,288 Total Patients Enrolled
3 Trials studying Depression
713 Patients Enrolled for Depression
Nova Scotia Health AuthorityLead Sponsor
288 Previous Clinical Trials
94,162 Total Patients Enrolled
10 Trials studying Depression
32,148 Patients Enrolled for Depression
Centre for Addiction and Mental HealthOTHER
375 Previous Clinical Trials
82,487 Total Patients Enrolled
92 Trials studying Depression
17,271 Patients Enrolled for Depression
McGill UniversityOTHER
414 Previous Clinical Trials
1,018,280 Total Patients Enrolled
15 Trials studying Depression
2,033 Patients Enrolled for Depression
McMaster UniversityOTHER
918 Previous Clinical Trials
2,615,893 Total Patients Enrolled
36 Trials studying Depression
5,473 Patients Enrolled for Depression
Queen's UniversityOTHER
375 Previous Clinical Trials
124,592 Total Patients Enrolled
33 Trials studying Depression
6,803 Patients Enrolled for Depression

Media Library

Brexpiprazole (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT05017311 — Phase 4
Depression Research Study Groups: Random Allocation; Escitalopram + Brexpiprazole, Allocation by Predictive Biomarker Algorithm; Placebo, Random Allocation; Placebo, Allocation by Predictive Biomarker Algorithm; Escitalopram + Brexpiprazole
Depression Clinical Trial 2023: Brexpiprazole Highlights & Side Effects. Trial Name: NCT05017311 — Phase 4
Brexpiprazole (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05017311 — Phase 4
~267 spots leftby Dec 2028
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