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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 8 visit 10
Summary
This trial will evaluate the safety and effectiveness of MYDAYIS as an add-on treatment for adults with bipolar depression. The results will not be used to get MYDAYIS approved for this purpose.
Who is the study for?
Adults aged 18-55 with Bipolar I or II disorder, currently having a major depressive episode despite stable mood stabilizer or antipsychotic therapy. They can have attention deficit or binge eating disorders and continue behavioral treatments. Excluded are those with certain mania scores, MAOI use, drug abuse history, significant heart issues, pregnancy without contraception use, recent suicidality attempts or ideation.
What is being tested?
The study is testing MYDAYIS Extended-Release Capsules as an additional treatment for bipolar depression in adults. Participants will either receive the actual medication or a placebo over an 8-week period at multiple sites to assess its safety and effectiveness.
What are the potential side effects?
Potential side effects of MYDAYIS may include increased heart rate and blood pressure, appetite changes, dry mouth, anxiety/nervousness; it's not suitable for individuals with known hypersensitivity to amphetamines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 8 visit 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 8 visit 10
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Montgomery-Asberg Depression Rating Scale (MADRS) score
Secondary study objectives
Change in Binge Eating Scale (BES) score
Change in Clinical Global Impression for Bipolar Disorder (CGI-BP) score
Change in Digit Symbol Substitution Test (DSST) score
+9 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Mydayis - ActiveActive Control1 Intervention
MYDAYIS®, Oral administration, dose regimen for Double blind phase and open label phase.
12.5 mg x 7 days. 25 mg x 7 days 37.5 mg x 14 days 50 mg daily x 28 days
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo, Oral administration, dose regimen for Double blind phase and open label phase.
12.5 mg x 7 days. 25 mg x 7 days 37.5 mg x 14 days 50 mg daily x 28 days
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,343 Previous Clinical Trials
3,062,259 Total Patients Enrolled
Lindner Center of HOPEOTHER
28 Previous Clinical Trials
1,305 Total Patients Enrolled
Mark A FryePrincipal InvestigatorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of misusing prescription stimulant medications.You have Tourette's syndrome.You have experienced episodes of extreme excitement or mania caused by stimulant medications in the past.You currently have a problem with drinking alcohol, using drugs like opiates or cannabis, or you have recently stopped using them within the past 3 months.You have had a severe allergic reaction, like swelling or difficulty breathing, to amphetamines or any other ingredients in MYDAYIS.You have a history of severe seizures, but it's okay if you had febrile seizures as a baby.Men who do not use condoms correctly or consistently.Patients who have both attention deficit disorder and binge eating disorder will be allowed to participate.You have a medical condition that is not stable or under control.You have shown signs of feeling very sad or thinking about hurting yourself, or you have attempted suicide in the past year.You can continue with therapy focused on your main diagnosis, like cognitive-behavioral therapy (CBT).You have a known condition that affects your blood vessels or have experienced Raynaud's phenomenon in the past.You have a specific type of eye condition called narrow angle glaucoma.You are currently going through a severe episode of depression that hasn't improved despite taking mood stabilizers and/or antipsychotic medications for at least 4 weeks.You have a severe kidney disease called end stage renal disease (ESRD).You have been diagnosed with a serious mental illness like schizophrenia or psychosis.You have a history of heart problems like abnormal heart structure, weak heart muscles, irregular heart rhythms, blocked heart arteries, stroke, or other serious heart-related issues.Your blood pressure is very high (above 160/100) or your heart rate is very fast (above 110 beats per minute).You have a high score on a test that measures the severity of your depression symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Mydayis - Active
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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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