This a study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female subjects diagnosed with severe and moderate postpartum depression(PPD). The study will consist of an up to 5-day Screening Period, 3-day Treatment Period, and 30-day Follow-up Period. Subjects must remain as inpatient during the study Treatment Period, which is approximately 60 hours in duration. Assessments and laboratory samples will be collected during the Treatment Period and the Follow-up Period.
PROJECT SUMMARY Chronic use of opiates is a rapidly escalating crisis in the United States, with over 4.3 million Americans dependent on opiate analgesic, an escalating rate of opiate overdose deaths, and a resurgence of intravenous heroin use leading to total societal cost exceeding $55 billion. The struggle to break the addiction cycle is likely due to factors that affect neural circuits that govern craving and cognitive control. There is growing interest in the utilization of prefrontal cortex repetitive transcranial magnetic stimulation (rTMS) as a novel, non-invasive, non-pharmacologic approach to decreasing craving among chronic opiate users. At this early stage of development, however, it is unclear if the best TMS strategy is to (Strategy 1, Aim 1) increase activity in the dorsolateral prefrontal cortex, or (Strategy 2, Aim 2) decrease activity in the ventromedial prefrontal cortex. To parametrically evaluate these two promising treatment strategies, we have developed a three-visit crossover design wherein a cohort of buprenorphine-maintained (as a therapeutic technique to address opiate dependence) opiate dependent individuals will receive interleaved TMS/BOLD imaging and our established MRI-based thermal pain paradigm immediately before and after rTMS. We will also measure subjective pain and opiate craving ratings. The relative efficacy of Strategy 1 vs 2 will directly translate to development of a large clinical trial of rTMS as an innovative, new treatment option for pain in opiate dependent individuals.
This study aims to conduct focus groups with adolescents and parents (30 adolescents and 30 parents) to gather feedback to help design an integrated psychological therapy for co-occurring PTSD and substance use among adolescents (Teen COPE). This information will be used to make revisions to the new Teen COPE Therapist Guide and Patient Workbook.
This study will examine the effect of N-Acetylcysteine (NAC), an over-the-counter antioxidant supplement on brains of youth (ages 15-19) using magnetic resonance imaging (MRI). 50 adolescents will receive, in a counterbalanced order, a 10-day course of NAC 1200 mg twice daily and a subsequent 10-day course of matched placebo twice daily, separated by 11 days. Urine and blood samples will be collected at baseline and urine samples again before and after each course of medication treatment. Participants will receive a 1- hour MRI scan at baseline and after each treatment trial.
You/your child could be eligible to participate if he or she is:
Between the ages of 15 and 19.
Has consumed alcohol.
Participants must provide informed consent and youth under 18 must have parental consent to participate.
Compensation is available to those who qualify.
We will study healthy adults with a brain stimulation tool (TMS) either inside or outside of the MRI scanner, and test with EEG whether it matters where we place the TMS coil on the head. The TMS induced changes in EEG have been proposed as a surrogate measure of brain connectedness, which changes greatly when we are conscious and when we are not.
The study involves use of a new quit-smoking smartphone application. Participants will use the app for two days, which involves completing surveys several times a day (approx. 15 min each) and logging any smoking activity. Participants do not need to make a quit-attempt. Participants will have the opportunity to make suggestions that may improve the development of the app.
Alcohol use disorders (AUD) and intimate partner aggression (IPA) frequently co-occur. There are significant health and economic burdens associated with AUD and co-occurring IPA, and little empirical data to guide treatment efforts. The neuropeptide oxytocin may help mitigate both AUD and IPA. However, clinical data examining oxytocin?s effects on human aggression is scant. The proposed study is designed to address these gaps in the literature by utilizing a human laboratory paradigm to test the effects of oxytocin on craving and aggression among couples with AUD and co-occurring IPA.
Major depressive disorder is a common, severe, chronic and often life-threatening illness. It is now the leading cause of disability worldwide. There is a clear need to develop novel and improved therapeutics for treatment-resistant major depression.
Studies with esketamine have shown robust antidepressant effects in several clinical studies and it has been well tolerated in these clinical studies.
The main purpose of this study is to assess the long-term safety, tolerability, and effectiveness of esketamine nasal spray plus a newly initiated oral (taken by mouth) antidepressant in patients with treatment-resistant depression.
All patients in this 60 week study will be treated with esketamine nasal spray plus a new oral anti-depressant. The new oral anti-depressant will be one of the following approved and marketed oral antidepressants: duloxetine (Cymbalta), escitalopram (Lexapro), sertraline (Zoloft), or venlafaxine extended release (Effexor XR).
Currently there is an interest in optimizing rTMS protocols and in particular theta burst stimulation as both a therapeutic and investigational research tool. In a recent publication by Gamboa et al. 2010 it was shown that extended theta-burst stimulation duration (80 seconds) might have reverse effects on cortical excitability when compared to the original Huang et al. 2005 publication (40 seconds). While the post treatment effects of the original Huang et al. 2005 protocol were successfully replicated, when cTBS protocols were doubled to 1200 pulses over 80 seconds and the iTBS protocols were doubled to 1200 pulses over 390 seconds, there was increased facilitation after the prolonged cTBS and decreased excitability after prolonged iTBS. In Hanlon et al. 2015 a novel theta burst paradigm (5 minutes) is described in which two trains of 1800 pulses of cTBS, separated by a one-minute interval. This study aims to replicate the findings of the Gamboa and Huang protocols as well as investigate how novel theta burst stimulation paradigms such as those described in Hanlon et al. 2015, which are currently being explored as therapeutic methods in addiction change cortical excitability.
The goal of this pilot study is to determine if, in treatment-seeking substance dependent individuals, ten sessions of continuous theta burst transcranial magnetic brain stimulation (cTBS) over a brain region involved in craving (medial prefrontal cortex) can lower an individual's craving and brain response to drug-related cues. This study involves a screening visit, followed by one MRI visit, followed by ten cTBS treatment visits on consecutive days. There will be three follow-up MRI visits: the first will immediately follow completion of a 28-day outpatient treatment program, while the second and third will be one month and two months post-treatment.