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Study to Assess the Efficacy and Safety of Adjunctive NBI-1065845 in Adults With Major Depressive Disorder (MDD) (SAVITRI)
The purpose of this study is to evaluate the efficacy of NBI-1065845 compared with placebo used in addition to oral antidepressants in adults with MDD on improving symptoms of depression.
• The subject has completed written informed consent.
• At the time of signing the informed consent, subject must be 18 to 65 years of age, inclusive.
• The subject has a primary diagnosis of Major Depressive Disorder (MDD), without psychotic features, meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
• Subject must have had inadequate response to antidepressant treatment.
• Subject is currently on stable pharmacological treatment for depression.
• Subject must have a total Hamilton Depression Rating Scale-17 Item (HAMD17) score ≥ 22 at screening.
• Subjects must have been taking current antidepressant medication(s) for ≥ 8 weeks.
• Subjects must be willing to comply with all study procedures and restrictions.
• Subject is pregnant or breastfeeding.
• Subject has an unstable medical condition or chronic disease.
• Subject has a history of neurological abnormalities.
• Subject is currently diagnosed with or prior diagnoses of psychiatric disorder which was the primary focus of treatment other than MDD.
• The subject's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT).
• The subject has an alcohol or substance use disorder.
• In the Investigator's opinion, the subject is not capable of adhering to the protocol requirements.
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)
Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.
Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents
Study Objective: to develop a phone-based intervention to aid parents of suicidal adolescents to adhere to lethal means safety. Lethal means counseling is the practice of educating patients and their families about limiting access to items that can be used to attempt suicide. Though lethal means counseling is standard practice in treating suicidal patients, there is little experimental literature related to its utilization across different providers and its efficacy. Further, there is a significant gap in the literature on lethal means counseling as it relates to adolescents. The proposed project will investigate a novel text message-based intervention aimed to promote lethal means safety.
• Proficiency in spoken and written English
• Own cell phone that has internet capabilities
• Adolescent participants are patient's at Children's Health SPARC IOP (ages 12-17)
• Adult participants are parents and/or legal guardians of adolescent participants (ages 18+)
• Non-English speaking