This study examines the effects of the FDA-approved medication Gabapentin among individuals with Bipolar Disorder who smoke marijuana. Participants in the study will take Gabapentin and matched placebo (one at a time) for 5 days each. There are 5 study visits, including 2 MRI scans.
We recently completed an NIMH R34 in which we piloted a patient- and provider-informed tablet-based toolkit designed to facilitate delivery of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) ? a treatment that was selected because it addresses a wide range of symptoms using techniques shared by other treatments for emotional and behavioral disorders. The tablet-based toolkit consists of numerous components (e.g., videos, interactive games, drawing applications) that are designed to facilitate provider-patient interactions in a way that enhances children?s engagement and supports adherence to the treatment model. The tablet-based toolkit was very well received by children, caregivers, and providers in our pilot work. Moreover, all benchmarks for feasibility outlined in our NIMH R34 application were met or exceeded. We now propose to conduct a hybrid effectiveness-implementation trial to examine the extent to which the tablet intervention may improve fidelity, engagement, and children?s mental health outcomes. We will conduct a randomized controlled trial with 120 mental health providers and 360 families in partnership with dozens of clinics in the Carolinas and Florida. Providers will be assigned randomly to tablet-facilitated vs. standard TF-CBT. Youth aged 8-16 years with clinically elevated symptoms of PTSD will be recruited. Baseline and 3-, 6-, 9-, and 12-month post-baseline assessments will be conducted by independent, blind evaluators. Sessions will be videorecorded for observational coding of engagement and fidelity by independent raters blind to study hypotheses. We will also examine costs and conduct semi-structured interviews with families, providers, supervisors, and agency leaders to inform future dissemination and implementation initiatives. Technology-based resources that are scalable, easy to use, and designed for efficient integration into everyday practice may have sustained national impact. The return on investment of these initiatives will ultimately rest on their potential to improve the spread of best-practice treatments and the quality with which they are delivered to the children who need them.
There is an ethical obligation to provide continued intranasal esketamine treatment to subjects who participated in select Phase 3 studies and for whom the benefit versus risk has been favorable. This study provides an opportunity for subjects who have participated in the ESKETINTRD3004 study to continue to receive open label intranasal esketamine until: it is commercially available or a pre-approval access program is made available to the subject in the subject?s respective country; the subject does not benefit from further treatment (based on the investigator?s clinical judgment), the subject withdraws consent; or the company terminates clinical development of intranasal esketamine for Treatment Resistant Depression (TRD).
This study examines the effects of the medication gabapentin and the supplement n-acetylcysteine among individuals with Bipolar Disorder who regularly drink alcohol. Participants in this study will take gabapentin, n-acetylcysteine, and matched placebo (one at a time) for 5 days each. There are 8 study visits, including 3 MRI scans.
Recent research suggests that a new kind of treatment repetitive transcranial magnetic stimulation (rTMS) can help people with addictions quit. This study seeks to recruit individuals who are currently heavy cannabis users, who are attempting to quit using cannabis. In addition to having a 50% chance of receiving rTMS, participants will be given a behavioral treatment with known efficacy.
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 7-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.
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.
The purpose of this study is to understand factors contributing to managing emotions, behavior problems, and substance use risk among girls. Middle school adolescent girls will be asked about their thoughts and feelings about themselves and their ethnic group, perceptions, and discrimination. They will also report on their behavior and substance use risk. Their reactions to recent incidents of unfair treatment or disciplinary action will also be assessed.
The purpose of this study is to understand thoughts, experiences, emotions, and behaviors of African American teens and their families. African American teens and their families will be asked about their thoughts and feelings about themselves and their ethnic group, perceptions, and discrimination. They will also report on their behavior and substance use.
The goal of this study is to receive Veteran feedback on an intervention being developed for female Veterans to reduce their risk of alcohol misuse and sexual assault. We are recruiting 20 female Veterans who engage in alcohol misuse to receive feedback on the intervention content. Feedback will be integrated into the intervention prior to being used with female Veterans.