Research

Currently Recruiting: OPTIMUM-D Study

ClinicalTrials.gov ID: NCT05017311

The purpose of the OPTIMUM-D (Optimized Predictive Treatment In Medications for Unipolar Major Depression) Study is to test whether a specific combination of biomarkers discovered during previous studies can help predict how someone experiencing a major depressive episode will respond to treatment. The study will also explore other possible biomarkers that may predict treatment response, which may help in the future development of tests that can guide treatment choice more effectively and more quickly.

Eligible participants will receive monetary compensation, antidepressant treatment, and clinical care for 12 weeks.

General Information

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.

Treatment:

Drug: Escitalopram

Drug: Brexpiprazole

Learn more from one of our participants:

Recruiting Regions

Contact Information

British Columbia

Alberta

Nova Scotia

Ontario

Frequently Asked Questions (FAQs)

Click below to explore frequently asked questions (FAQs) about the OPTIMUM-D Study, including who may be eligible to participate and what to expect from the research process.

Who may be eligible to participate?

You may be eligible to participate if you are 18 to 65 years old and meet the criteria for one of the following groups:

Individuals with Depression

  • You have major depressive disorder (MDD) and are currently experiencing a depressive episode.
  • You have moderate to severe symptoms of depression, as determined by the study team.
  • You have not taken antidepressants or other medications that affect mood for the required period before the study begins.
    • This is generally at least 1 week for most medications and 5 weeks for fluoxetine (Prozac). Some medications may be allowed.
  • You are comfortable speaking and reading English and completing study interviews and questionnaires.

Healthy Individuals without Depression

  • You have no history of mental health or psychiatric disorders.
  • You do not have significant ongoing physical health conditions that could affect participation.
  • You are comfortable speaking and reading English and completing study interviews and questionnaires.

Please note: These are general eligibility guidelines. The study team will review your health and treatment history and complete an assessment to determine whether you may be eligible to participate.

What can I expect if I participate in the OPTIMUM-D Study?

If you are eligible and choose to participate, you will meet with the study team regularly over the course of the study. You will receive study treatment and complete questionnaires and assessments about your health and depression. You may also take part in an MRI scan, EEG, and cognitive assessments that measure areas such as memory and attention, and provide blood, urine, stool, and speech samples. The study team will explain each assessment to you before it takes place.

How long does the study take?

The OPTIMUM-D Study lasts approximately 12 weeks. You will have several study visits during this time, and the study team will provide you with a schedule so you know what to expect at each visit.

What treatment will I receive?

Participants with depression will receive escitalopram (Lexapro), an antidepressant commonly used to treat depression. Depending on your study group, you may also receive brexpiprazole (Rexulti), a medication that may be added to an antidepressant to help treat depression, or a placebo. The study team will explain your treatment and what to expect before you begin.

How is my treatment decided?

Participants are assigned to one of two treatment groups. In one group, treatment is assigned randomly. In the other group, researchers use information collected during the study to help determine which treatment may be more suitable for the participant.

The purpose of the study is to learn whether using this information can help predict which treatment may work best for people with depression.

What if I am currently taking medication for depression?

If you are currently taking medication for depression, you may still be able to participate. The study team will review your current medications and treatment history with you to determine your eligibility.

If you need to stop or gradually reduce your medication to participate, the study team will support you throughout the process. Any medication changes will be carefully managed and closely monitored by a study physician or qualified medical professional.

Is there compensation for participating?

Participants may be eligible to receive compensation for their time and participation in the study. Your study site can provide more information about compensation and payment details.