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Brexpiprazole for Bipolar Disorder
Phase 3
Recruiting
Led By Serge Beaulieu, MD, PhD, FRCPC, DFAPA
Research Sponsored by Douglas Mental Health University Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Summary
This trial is testing whether Brexpiprazole is an effective treatment for bipolar disorder type I depression by improving mood symptoms, cognitive capacity, and global functioning.
Who is the study for?
Adults aged 18-75 with Bipolar I Disorder currently experiencing treatment-resistant depression, who have tried at least one other treatment without success. Participants must be on a mood stabilizer and have normal heart function. They cannot join if they are at high suicide risk, have psychotic symptoms, certain neurocognitive disorders, uncontrolled seizures, known allergies to Brexpiprazole or its components including lactose intolerance.
What is being tested?
The trial is testing the effectiveness of Brexpiprazole as an additional treatment for depressive episodes in Bipolar I Disorder. It aims to improve mood symptoms and cognitive functions while monitoring changes in brain structures associated with these improvements.
What are the potential side effects?
Brexpiprazole may cause side effects such as restlessness, weight gain, digestive issues, fatigue, anxiety or agitation. Some people might experience muscle movements they can't control (especially in their face), or an increase in blood sugar levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline Depressive Symptoms as Assessed by MADRS at 8 weeks
Secondary study objectives
Change from Baseline Cognition as Assessed by the DSST at 12 weeks
Change from Baseline Cognition as Assessed by the DSST at 6 months
Change from Baseline Cognition as Assessed by the DSST at 8 weeks
+29 moreSide effects data
From 2019 Phase 4 trial • 51 Patients • NCT0314999116%
Dizziness
16%
Alteration in Taste
12%
Restlessness/Akathisia
8%
Headache
8%
Dissociation/Detachment
8%
Insomnia/Sleep disturbance
8%
Sedation
8%
Constipation
8%
Gastric Distress
4%
Weight gain
4%
Increased salivation post dose
4%
Increased appetite
4%
Twitching of left side lower lip
4%
Light headedness
4%
Panic episode
4%
Lethargy
4%
Shakiness
4%
Unsteadiness of gait
4%
Irritability
4%
Elevated alt
4%
Hot flashes
4%
Bruxism
4%
Nausea
4%
Bi-lateral hand pain
4%
Euphoria
4%
Irregular/Early Menses
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brexpiprazole
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: PatientExperimental Treatment1 Intervention
Individuals diagnosed with Bipolar Disorder Type I or Type II and suffering a major depressive episode who will receive an adjunctive and variable dose of Brexpiprazole treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brexpiprazole
2013
Completed Phase 4
~4040
Find a Location
Who is running the clinical trial?
Douglas Mental Health University InstituteLead Sponsor
29 Previous Clinical Trials
2,667 Total Patients Enrolled
McMaster UniversityOTHER
906 Previous Clinical Trials
2,613,183 Total Patients Enrolled
Jewish General HospitalOTHER
140 Previous Clinical Trials
278,510 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, and I use birth control.You have never had any mental health disorders.I am using effective birth control or am not able to have children.I have been feeling very sad for 2 to 52 weeks, and treatments haven't helped.You have metal implants in your body.I have been diagnosed with Bipolar Disorder type I or II.I am lactose intolerant or have a similar condition.I do not have active inflammatory diseases like lupus or Crohn's.I have had bad reactions to certain medications before.I have been diagnosed with severe psychotic symptoms.I am currently taking fluoxetine or carbamazepine.I am currently taking risperidone, olanzapine, quetiapine (over 100mg/day), ziprazidone, or another antipsychotic.I do not have any untreated mental health issues or unstable medical conditions like thyroid problems, diabetes, heart issues, or high blood pressure.I have trouble swallowing.My seizures are not controlled by medication.I have a history of serious heart conditions or irregular heartbeats.I have a diagnosed eye condition.I experience uncontrollable twitching, especially in my face.I have been diagnosed with a cognitive impairment.I am taking a mood stabilizer like lithium, valproate, lamotrigine, or low-dose quetiapine.You have an artificial heart valve.You are afraid of small, enclosed spaces.You have a heart or vascular clip.You are currently pregnant.I have a history of serious heart problems or irregular heartbeats.I am either male or female.I have tried at least one treatment for my current depression without success.The study involves a patch that goes on your skin.You have a pacemaker.You have an aneurysm clip.You have a history of alcohol or drug abuse.I have been diagnosed with Bipolar Disorder type I.I am between 18 and 75 years old.You are able to give your consent.\n
Research Study Groups:
This trial has the following groups:- Group 1: Patient
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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