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Atypical Antipsychotic

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

Phase 4
Recruiting
Led By Sidney H Kennedy, 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 8 and week 8 to week 12
Awards & highlights

CAN-BIND-17 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.Check my eligibility
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.See study design
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.

CAN-BIND-17 Trial 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 haven't taken any psychiatric medication for the required time before my first visit.
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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.

CAN-BIND-17 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline
Secondary outcome measures
Clinical response
Remission at Week 8
Time to clinical response
Other outcome measures
Week 12 clinical outcome - Remission
Week 12 clinical outcome - Response

CAN-BIND-17 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?

McMaster UniversityOTHER
879 Previous Clinical Trials
2,596,616 Total Patients Enrolled
34 Trials studying Depression
5,181 Patients Enrolled for Depression
University of CalgaryOTHER
783 Previous Clinical Trials
845,538 Total Patients Enrolled
30 Trials studying Depression
10,190 Patients Enrolled for Depression
McGill UniversityOTHER
392 Previous Clinical Trials
984,107 Total Patients Enrolled
14 Trials studying Depression
1,915 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of disorder is the Allocation by Predictive Biomarker Algorithm; Escitalopram + Brexpiprazole treatment typically used to address?

"Major Depressive Disorder (MDD) is usually treated with a combination of Allocation by Predictive Biomarker Algorithm; Escitalopram + Brexpiprazole. This medication can also be effective at managing anxiety disorders, obsessive-compulsive disorder, and other antidepressive agents."

Answered by AI

Are participants being actively sought for this research?

"At this moment, the clinical trial is not open to applicants. Its initial posting was on September 1st 2021 and it has been revised most recently on September 3rd 2021. Other studies are available for those with psychosis, involutional depression or Allocation by Predictive Biomarker Algorithm; Escitalopram + Brexpiprazole - 1295 trials in total that seek participants."

Answered by AI

Is geriatric enrollment a priority in this medical research?

"For this particular trial, participants must be of legal age and not older than 60. Meanwhile, 196 studies are available for those younger than 18 years old, while 988 trials cater to seniors."

Answered by AI

How has the efficacy of Allocation by Predictive Biomarker Algorithm; Escitalopram + Brexpiprazole been evaluated in previous investigations?

"Currently, 31 clinical trials are underway that explore the efficacy of Allocation by Predictive Biomarker Algorithm; Escitalopram + Brexpiprazole. Of these ongoing studies, 11 have reached Phase 3 while being conducted at 59 distinct sites across New york City."

Answered by AI

May I be eligible to join this medical study?

"Participants of this trial must be 18-60 years old, have involutional psychosis, and a MADRS score greater than 24. Additionally, they should not have taken psychotropic medications in the past 5 half lives prior to enrollment. This study is seeking 400 outpatients for its research project."

Answered by AI

Has the FDA sanctioned Allocation by Predictive Biomarker Algorithm; Escitalopram + Brexpiprazole?

"The risk profile of Allocation by Predictive Biomarker Algorithm; Escitalopram + Brexpiprazole has been assessed as a 3, given that this is a Phase 4 trial and the intervention has already received regulatory approval."

Answered by AI

Are there many health care facilities administering this trial in North America?

"Currently, this experiment is running at 6 different sites: Hamilton, Kingston and Toronto are included in the list. To lessen travel time for potential participants it would be wise to choose a site located close proximity."

Answered by AI

How many volunteers are taking part in this experiment?

"The recruitment period for this medical trial has already elapsed, having first been posted on September 1st 2021 and last edited on the 3rd. However, there are presently 1295 clinical trials searching for participants with psychosis as well as 31 studies actively enrolling patients using an Allocation by Predictive Biomarker Algorithm; Escitalopram + Brexpiprazole protocol."

Answered by AI

Who else is applying?

What site did they apply to?
Queen's University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~267 spots leftby Dec 2028