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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline Depressive Symptoms as Assessed by MADRS at 8 weeks
Secondary outcome measures
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%
Alteration in Taste
16%
Dizziness
12%
Restlessness/Akathisia
8%
Insomnia/Sleep disturbance
8%
Gastric Distress
8%
Constipation
8%
Headache
8%
Sedation
8%
Dissociation/Detachment
4%
Euphoria
4%
Nausea
4%
Elevated alt
4%
Light headedness
4%
Irritability
4%
Irregular/Early Menses
4%
Bi-lateral hand pain
4%
Shakiness
4%
Increased appetite
4%
Hot flashes
4%
Increased salivation post dose
4%
Panic episode
4%
Weight gain
4%
Lethargy
4%
Bruxism
4%
Twitching of left side lower lip
4%
Unsteadiness of gait
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
~4150
Find a Location
Who is running the clinical trial?
Douglas Mental Health University InstituteLead Sponsor
29 Previous Clinical Trials
2,668 Total Patients Enrolled
McMaster UniversityOTHER
884 Previous Clinical Trials
2,598,258 Total Patients Enrolled
Jewish General HospitalOTHER
137 Previous Clinical Trials
271,986 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research include test subjects who are over 20 years of age?
"According to the study's inclusion criteria, patients must be aged 18-75. There are currently 220 trials underway for patients under 18 and 1063 for those over 65 years old."
Answered by AI
Will this clinical trial be a pioneer in the medical field?
"There have been a total of 9 clinical trials for Brexpiprazole over the course of 3 years. These studies took place in 14 cities across 3 countries, with the first one starting in 2017. The sponsor for the first trial was H. Lundbeck A/S and it completed its Phase 3 stage successfully with 315 patients. In total, 59 trials have been conducted since then."
Answered by AI
Can people with the relevant medical condition participate in this trial currently?
"According to the public registry, this study is presently recruiting patients. The listing was first created on May 10th, 2021 and updated most recently on March 21st, 2022."
Answered by AI
Has the Federal Drug Administration given their seal of approval to Brexpiprazole?
"There is both clinical evidence and multiple rounds of data supporting Brexpiprazole's safety, so it received a score of 3."
Answered by AI
Would I be able to join this clinical trial?
"Bipolar disorder patients that are aged 18-75 can qualify for this trial, of which there are 58 spots available."
Answered by AI
What other drugs has Brexpiprazole been tested with in previous studies?
"844-687-8522 is the contact number for more information related to clinical trial sites. 59 trials have been completed thus far, and of the 9 ongoing studies, many are based in Montreal, Quebec."
Answered by AI
How many people have been recruited for this experiment?
"That is correct, the online information does show that this study is looking for 58 individuals to take part. The trial was first advertised on May 10th 2021 and was last updated on March 21st 2022. There are 3 different research locations where potential participants could be recruited from."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Quebec
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Douglas Mental Health University Institute
How many prior treatments have patients received?
2
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