GZMH-RENEW-MDD-1
Summary
This study is testing whether brenipatide can help prevent depression from coming back in adults who are feeling better after treatment for Major Depressive Disorder (MDD).
MDD is a common mental health condition that causes ongoing sadness, loss of interest in activities, and other emotional and physical symptoms. Even when people improve with treatment, depression often returns. Right now, there are no medications approved only to prevent relapse in people with MDD. There is a need for better long-term treatment options.
Brenipatide is an investigational medication. It may help by supporting brain health, reducing inflammation, and affecting certain brain chemicals linked to mood.
This Phase 3 study will compare brenipatide to a placebo (a substance with no active medication). Participants will continue their regular antidepressant treatment. The main goal is to see if brenipatide can delay or prevent the return of depressive symptoms in people who are in remission or close to remission.
Eligibility
Eligible ages: 18 to 75
Inclusion criteria:
-Age
Be between 18 and 75 years old at the time they sign the consent form.
-Diagnosis and Depression History
Have been diagnosed with Major Depressive Disorder (MDD) based on standard medical guidelines (DSM-5), without psychotic symptoms.
Have had at least 3 depressive episodes in their lifetime.
Be in remission or near remission (feeling much better, but possibly with mild remaining symptoms) for 6 months or less at the first study visit.
Still be in remission or near remission at both screening and randomization visits, based on:
-Current Treatment
Be on a stable antidepressant treatment plan for at least 4 weeks before the first study visit.
Be willing to stay on the same medication plan during the study.
-Allowed treatment plans may include:
One antidepressant,
A combination of antidepressants, or
An antidepressant plus certain approved add-on medications (such as antipsychotics, mood stabilizers, lithium, stimulants, thyroid hormone, or limited-dose benzodiazepines).
If receiving psychotherapy, it must have been stable for at least 6 weeks, and the participant must agree to continue it unchanged during the study.
-Physical Health
Have a Body Mass Index (BMI) of 22.0 or higher at screening and at randomization.
-Sex and Birth Control
Individuals assigned male or female at birth may participate.
Participants who can become pregnant must agree to use approved birth control methods, according to local regulations and study guidelines.
-Study Participation Requirements
Participants must:
Be willing and able to attend study visits.
Follow study instructions.
Self-inject the study medication (or have a trained support person help).
Store and use the study medication as instructed.
Complete study diaries and questionnaires.
-Informed Consent
Be able to understand the study and sign a written informed consent form.
Agree to follow all study requirements and restrictions.
Exclusion criteria:
You cannot take part in this study if any of the following apply:
Certain Mental Health Conditions
-Schizophrenia, bipolar disorder, borderline personality disorder, or an eating disorder.
-Recent serious drug or alcohol problems (in the past 6 months).
-Current serious suicidal thoughts or a recent suicide attempt.
Diabetes or Hormone Problems
-Type 1 diabetes.
-Poorly controlled Type 2 diabetes.
-Certain thyroid cancers or a family history of them.
-Serious, uncontrolled hormone problems.
-Recent use of certain diabetes or weight-loss medicines (especially GLP-1–type drugs or insulin).
Serious Medical Conditions
-Severe kidney or liver disease.
-Certain cancers in the past 5 years (with a few exceptions).
-Serious stomach or digestion problems, including severe gastroparesis.
History of pancreatitis.
-Major heart problems in the past 6 months (such as heart attack or stroke).
-Severe heart failure.
-Planned major surgery during the study.
-Organ transplant (except corneal transplant).
-Very low blood counts or certain blood disorders.
-Recent Depression Treatments Not Allowed
-Recent treatment with ECT, TMS, ketamine, esketamine, deep brain stimulation, vagus nerve stimulation, or psychedelic drugs.
Other Reasons
-Positive drug test at screening (with one chance to repeat).
-Pregnant, breastfeeding, or planning pregnancy during the study.
-Currently in another clinical trial or recently in one.
-Previously received brenipatide in a study.
-Any condition that the study doctor believes would make participation unsafe.
Participate
Fill out the following form if you want to participate in this research
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Additional information
Contact information
403-210-6903; 403-210-6904
Principal investigator:
Thomas Raedler
Clinical trial:
Yes
REB-ID:
REB25-1711