8 Week Multi-site Study of MYDAYIS® for Bipolar Depression (NCT04235686) | Clinical Trial Compass
CompletedPhase 2
8 Week Multi-site Study of MYDAYIS® for Bipolar Depression
United States74 participantsStarted 2020-07-17
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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)
What they're measuring
1
Change in Montgomery-Asberg Depression Rating Scale (MADRS) score