8 Week Multi-site Study of MYDAYIS for Bipolar Depression

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    90
  • sponsor
    Mayo Clinic
Updated on 26 January 2021
depression
bipolar disorder
depressive disorder
antidepressants
scid
depressed mood
mania
depressive episode
lithium
mood stabilizer
valproate
binge eating disorder
structured diagnostic interview

Summary

This protocol is a Phase 2 multi-site study which aims to evaluate the safety and effectiveness of MYDAYIS® as adjunctive therapy for adults with bipolar depression. Results from this study WILL NOT be used to contribute to an approval of MYDAYIS ® for this indication.

Details
Condition Bipolar Disorder, Bipolar Disorders (Pediatric), Manic Disorders, bipolar depression, depression, bipolar
Treatment Placebo, Mydayis Extended-Release Capsule
Clinical Study IdentifierNCT04235686
SponsorMayo Clinic
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female between 18 and 55 years of age
Bipolar I or II disorder as confirmed by structured diagnostic interview by Axis I of the SCID by DSM-IV-TR
Currently experiencing a major depressive episode unresponsive to stable (i.e. at least 4 weeks) anti-manic mood stabilizers (lithium, valproate) and/or antipsychotic therapy, with or without concomitant antidepressant therapy
Symptom severity score 11 on the self-report version of the Quick Inventory for Depressive Symptomatology (QIDS-SR16) or score 11 on the Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C16) and 3 on the Clinical Global Impression for Bipolar Illness (CGI-BP) Depression Severity Scale
Patients with a comorbid attention deficit disorder and binge eating disorder will be included
Patients will be allowed to continue with their behavioral treatments (ie. CBT) targeted at their primary diagnosis

Exclusion Criteria

Ability to provide informed consent and understand fully English and score 90% on comprehension test questionnaire that reviews study goals
Clinically significant signs of suicidality from any of the following assessments
Response 4 on MADRS question # 10
Response 2 on QIDS-C or QIDS-SR question # 12
Yes response on Columbia Suicide Severity Scale (CSSR) Question # 3 (ideation without plan or intent) ,Question #4 (ideation with intent, but no plan), or Question # 5 (ideation, intent, and plan)
Suicide attempt within the past year, as defined by the Columbia-Suicide Severity Scale
Known lifetime history of DSM-IV-TR diagnosis of cocaine or methamphetamine abuse or dependence. Nicotine dependence will be an exception
Positive toxicology screen for drugs of abuse (ie. cocaine, methamphetamine, cannabis, opiates)
Known history of prescription abuse of stimulants
Lifetime history of stimulant-induced mania
Active abuse or dependence of alcohol, opiates or cannabis that is either current or less than 3 months full remission
Baseline Young Mania Rating Scale (YMRS) score 8
Patients with active psychosis identified by SCID or a diagnosis of schizophrenia, schizoaffective disorder, delusional or schizophreniform disorder
Known hypersensitivity, such as angioedema or anaphylaxis, to amphetamines or other ingredients of MYDAYIS
Clinically unstable medical disease
Known history of a structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, stroke or other serious cardiovascular problems
ECG with significant arrhythmias, conduction abnormalities, or voltage criteria met for left ventricular hypertrophy (unless cleared by cardiology consultation)
Uncontrolled hypertension (>160/100) or tachycardia (heart rate >110)
History of grand mal seizure; history of febrile seizure as infant permitted
Established vasculopathy or history of Raynaud's phenomena
Narrow angle glaucoma
Patients with end stage renal disease (ESRD)
Concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor
Tourette's syndrome
Women who are pregnant, lactating or of child-bearing potential and not using at least one adequate contraceptive measure (i.e. hormonal contraception-birth control pills-, intrauterine devices (IUD), tubal ligation or condoms during sexual intercourse)
Men who do not use adequate measures (male condoms)
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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