Anxiety & Depression Association of America

This is a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to assess the cognitive effects of lurasidone in bipolar I and II patients (manic depression) who are in remission from an episode. Participants who show cognitive impairment at the screening visit will be enrolled into the study and randomized at the baseline visit to receive either lurasidone or placebo adjunctive therapy in a 1:1 ratio for 6 weeks.

Type: Interventional

Start Date: May 2017

open study

Postpartum depression (PPD) affects 10-20% of women, with immigrant Latinas disproportionately affected. PPD prevention and treatment is limited among immigrant Latinas due to an array of structural and cultural factors, suggesting the need to deliver interventions outside of traditional healthcare settings. Virtual interventions have the potential to reduce barriers to mental health services for immigrant Latinas, but there is little research on the effectiveness of virtual interventions to reduce PPD symptoms. Mothers and Babies is an evidence-based group intervention based on principles of cognitive-behavioral therapy and attachment theory aimed at PPD prevention. Mothers and Babies was adapted for delivery via a virtual group format (Mothers and Babies Virtual Group; MB-VG), with a pilot study suggesting good feasibility and acceptability as well as improved mental health outcomes for immigrant Latinas. The proposed project is a Type 1 Effectiveness-Implementation randomized controlled trial among pregnant individuals and new mothers at risk for PPD based on elevated depressive symptoms and/or other established risk factors who are enrolled in early childhood programs across Maryland. A total of 300 women will be enrolled; 150 will receive MB-VG while 150 will receive usual family support services. The project aims to evaluate: 1) the effectiveness of MB-VG to reduce depressive symptoms, prevent onset of PPD, and improve parenting self-efficacy and responsiveness; 2) implementation of MB-VG; and 3) contextual factors influencing MB-VG effectiveness and implementation. Trained early childhood center staff will deliver MB-VG sessions, with intervention participants receiving virtual group sessions via Zoom using any electronic device (smartphone, tablet, laptop). Maternal self-report surveys are conducted at baseline, 1 week, 3 months, and 6 months post-intervention, with structured clinical interviews also conducted at 3- and 6-months post-intervention. The study is the first to deliver a virtual PPD preventive intervention to immigrant Latinas and to evaluate its impact. Given its virtual delivery modality, MB-VG can be easily replicated and scaled to other family support programs and settings serving immigrant Latinas. If effective and implemented broadly, more immigrant Latinas will receive mental health services and fewer will suffer the negative consequences associated with PPD.

Type: Interventional

Start Date: Oct 2023

open study

TRIAGE-Psych is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored psychiatry clinical trials.

Type: Observational

Start Date: Dec 2021

open study

This study aims to test the effectiveness of virtual reality (VR) as a non-pharmaceutical intervention to reduce pain and anxiety in children undergoing painful procedures in Phlebotomy, Radiology, Infusion, Orthopedics, Gastroenterology, and Immunology, amongst others, at CHLA, as measured by self- and proxy-report. Examples of the painful procedures include IV sticks, cast removals, allergy testing, and anorectal manometries.

Type: Interventional

Start Date: Feb 2016

open study

The goal of this clinical trial is to evaluate the impact of ROSE in individuals with adverse childhood experiences. The main question it aims to answer is, compared to enhanced treatment as usual, does the delivery of ROSE within a collaborative care model improve depressive symptom trajectories and prevent the development of perinatal depression. Participants will be randomized to either enhanced treatment as usual or the ROSE intervention, delivered by a care manager within a perinatal collaborative care program. They will complete self-reported surveys of their depression symptoms every 4 weeks to inform their symptom trajectories. They will also complete clinical interviews to establish any incident diagnoses of a major depressive episode.

Type: Interventional

Start Date: Jul 2023

open study

This pilot open-label study examines the effects of a combination of dasatinib plus quercetin - two drugs that have known senolytics properties - on physiological aging in older individuals with depression or schizophrenia.

Type: Interventional

Start Date: Jul 2023

open study

The purpose of this study is to assess the efficacy of the combined interventions, Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT) or P-STAIR, for treating maternal PTSD and reducing maltreatment recidivism.

Type: Interventional

Start Date: May 2021

open study

There are few treatment options available for patients once they have failed standard psychopharmacological therapy for generalized anxiety disorder. Existing brain stimulation methods such as rTMS fail to target deep brain structures associated with anxiety disorders; structures such as the amygdala. In this double-blind sham-controlled clinical trial, the investigators propose to establish baseline severity of anxiety in 48 patients, then deliver eight treatments over four sessions of focused ultrasound stimulation to the amygdala. Anxiety severity will be assessed using standard psychometric scales after each session, and at follow-ups.

Type: Interventional

Start Date: Jul 2021

open study

The overall goal of this study is to develop an mHealth intervention (Suubi-Mhealth) for use among Ugandan youth (14-17 years) with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs. This digital therapy intervention delivered via a mobile application, will utilize the core tenets of cognitive-behavioral therapy (CBT) found to improve depression and ART adherence.

Type: Interventional

Start Date: Nov 2022

open study

This is a two-site randomized controlled trial, with two goals. First, the investigators aim to demonstrate that single-session interventions for mild-to-moderate anxiety and depression can generate statistically significant symptom change as a main effect across control and experimental (i.e. personalized) conditions. Second, the investigators hope to establish the additional incremental efficacy of personalization via person-specific intensive longitudinal data collection and analysis.

Type: Interventional

Start Date: Jan 2023

open study

This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years).

Type: Observational

Start Date: Jun 2021

open study

This study evaluates the antidepressant effects of an accelerated schedule of theta-burst stimulation, termed accelerated intermittent theta-burst stimulation (aiTBS), in individuals with borderline personality disorder (BPD) or trait and comorbid mood depressive disorder (MDD) or bipolar II disorder in a current mood depressive episode (MDE).

Type: Interventional

Start Date: Jul 2021

open study

The goals of this study are to assess the feasibility and acceptability of a dietary intervention to increase choline intake through whole foods (eggs) in pregnant and lactating women for mental health benefits. We will achieve these goals through the following specific aims: 1. To determine the effects of including eggs as a source of choline in the diets of pregnant and lactating women on biomarkers, we will measure concentrations of choline and choline metabolites in maternal serum and breastmilk at 24-26 weeks gestation and 4-6 weeks postpartum. 2. To evaluate adherence to a food-based dietary choline intervention in pregnant and lactating women, we will track intake via daily photo and written food logs. 3. To assess the feasibility of collecting repeated measures of dietary intake and maternal depression, anxiety, and stress in the perinatal period, we will track completion rates for project surveys. The data from this study will inform the design and sample size calculations for a longitudinal cohort study that will assess neurological outcomes for both mother and child and follow the offspring over time to reassess mental health and cognitive development in preschool-aged children. Choline is an underconsumed nutrient of concern for public health, specifically during pregnancy and lactation. There is limited data on biomarker or health outcomes related to perinatal choline intake. Determining relationships between perinatal choline intake and maternal mental health has the potential to impact public health by ultimately informing development of nutrition education materials in the clinical setting focused on encouraging maternal perinatal choline intake through whole foods such as eggs.

Type: Interventional

Start Date: Jun 2023

open study

We are conducting an eight week longitudinal study to learn if blood levels of certain naturally occurring compounds and genetic markers differ between patients with depression and healthy adults who are not depressed, and if any such differences relate to memory performance, mood, and neurobiology. We are also interested in how the gut microbiome is affected by antidepressant treatment. We will do this by comparing the unmedicated depressed patients with matched healthy controls at baseline and then following the depressed patients over the course of eight weeks of standardized antidepressant treatment to gauge which baseline abnormalities normalize over the course of treatment.

Type: Interventional

Start Date: Dec 2010

open study

The goal of this clinical trial is to test whether an established preventive intervention (group interpersonal therapy) delivered virtually shows the same benefits for preventing postpartum depression as it does when delivered in person.

Type: Interventional

Start Date: Mar 2023

open study

Although anxiety is one of the most common and debilitating mental health conditions affecting children and adolescents, the vast majority of sufferers do not receive effective treatment. Cognitive-behavioral therapy (CBT) is an evidence-based, frontline treatment for pediatric anxiety, yet many community-based practitioners do not implement CBT with high fidelity, which can detrimentally affect its clinical impact. The goal of this study is to develop and test an online platform to support community providers' effective use of CBT for pediatric anxiety.

Type: Interventional

Start Date: Apr 2023

open study

This study will examine the efficacy of an internet-based brief intervention designed to reduce risky behavior in Soldiers as they transition from Active Duty into the civilian workforce as a Veteran. Up to 700 soldiers intending to separate from the Army will be recruited, with the intention of drawing a final sample of 450 participants. Study participants will be randomly assigned to either the intervention or the control group, stratified by age and gender.

Type: Interventional

Start Date: Mar 2021

open study

This is a prospective, crossover study of healthy participants evaluating the impact of passive vs. active virtual reality (VR) games on heat pain threshold (HPT).

Type: Interventional

Start Date: Aug 2023

open study

The goals of this study are to replicate previous findings of genetic predictors of response to clozapine and other antipsychotic drugs.

Type: Interventional

Start Date: Nov 1998

open study

Depression and anxiety disorders rank in the top ten causes of years lived with disability. Less than 50% of patients experiencing long-lasting improvements to current gold-standard treatments. Two gold-standard behavioral interventions include behavioral activation, focused on enhancing approach behavior towards meaningful activities, and exposure-based therapy, focused on decreasing avoidance and challenging negative expectations. While these interventions have divergent treatment targets, there is little knowledge to inform which strategies should be used in the frequent case of comorbid anxiety and depression. Approach-avoidance decision-making paradigms focus on assessing responses when faced with potential rewards and threats, tapping into processes important for both anxiety and depression as well as behavioral activation and exposure-based therapy. For this study, investigators will recruit individuals reporting both anxiety and depression symptoms and randomize them to one of three different interventions: (1) behavioral activation, (2) exposure-based therapy, and a non-specific therapy approach (3) supportive therapy. Participants will complete clinical, self-report, behavioral, and functional magnetic resonance imaging (fMRI) assessments before and after therapy. Investigators will use a computational approach to model factors that may influence one's behavior during approach-avoidance decision-making, including drives to avoid threat versus approach reward and confidence versus uncertainty in one's decisions. This project will accomplish the following aims (1) Determine how changes in brain and behavior responses during approach-avoidance conflict relate to changes in mental health symptoms with the different therapy approaches, (2) Determine the degree to which baseline brain and behavior responses during approach-avoidance conflict predict response to the different therapy approaches, above and beyond the influence of demographics and baseline symptom severity. In addition, by including peripheral blood draws and measures of grace matter volume, the project will also accomplish the following aims: (1) Determine whether kynrenine metabolites measures peripherally may be beneficial as a biomarker of treatment response and (2) determine whether there is an association between change in kynurenine metabolites and changes in gray matter volume with treatment. Results will enhance understanding of how different psychotherapy approaches (behavioral activation, exposure-based therapy) may impact brain responses and decisions when faces with potential reward versus threat and approach versus avoidance drives. In addition, results will have important implications concerning the potential for a more personalized approach to psychotherapy, enhancing knowledge of which types of therapy strategies may be most beneficial for which individuals.

Type: Interventional

Start Date: Sep 2020

open study

The collection of patient self-report and diagnostic data will allow us to examine the efficacy of the treatment delivered in the McLean Anxiety Mastery Program. Using data gathered through routine clinical care, the investigators seek to explore whether patients in treatment show improvements from admission to discharge, compared to patients on the waitlist, and whether these gains are maintained three months post-discharge. The following are included as examples of some of the study's hypotheses.

Type: Interventional

Start Date: Oct 2014

open study

The goal of this study is to test whether a single low-dose of IV ketamine given in the emergency department to adolescents with treatment-resistant depression and suicidal ideation can reduce depression symptoms and suicidal thoughts compared to placebo. Participants will complete depression scales at baseline, and 1 hour, 3 hours, 1 day, 3 days, and 7 days after receiving the treatment.

Type: Interventional

Start Date: Mar 2022

open study

This epidemiologic research is being conducted as an observational prospective case series outcomes study of the use of advanced integrative specialty medical care and its effect on adult and pediatric patients with chronic or serious illnesses or mental health disorders.

Type: Observational

Start Date: Jul 2020

open study

The investigators are conducting a randomized controlled trial to evaluate the antidepressant effects of nitrous oxide in people with Major Depressive Disorder (MDD). MDD is a global medical condition that causes significant health and economic burden. Recent studies have shown that a single dose of ketamine, an NMDA-antagonist, has fast and long lasting anti-depressant effect. Nitrous oxide, another NMDA-antagonist, is widely used for anesthesia and analgesia, safer to administer and has fewer side effects than ketamine. A randomized controlled crossover feasibility study showed significant reduction in depressive symptoms at 2 and 24 hours after a single 1-hour treatment session of inhaled nitrous oxide compared with placebo. Nitrous oxide is inexpensive and can be safely administered by any trained clinician. If found to be efficacious, it could be used to provide rapid anti-depressant effect whilst the benefit of traditional anti-depressants has its delayed effect. Another potential application could be in acutely suicidal patients. This investigated-initiated phase 2b trial will enable confirmation and extension of the findings from the feasibility study, and identify the optimal dose and regimen in a broader population of those with MDD. Participants will be randomized to receive a weekly 1-hour inhalational sessions of either nitrous oxide or placebo (oxygen-air mixture) for 4 weeks, and the nitrous group will be further randomly assigned to a dose of 50% nitrous oxide or 25% nitrous oxide. Depression severity will be assessed by a blinded observer pre-treatment and at weekly intervals during and for 4 weeks after treatment using the Hamilton Depression Rating Scale.

Type: Interventional

Start Date: Jan 2019

open study

Almost 18 million US adults have alcohol use disorders (AUD), with one third of these individuals also diagnosed with anxiety disorders (AXD). The coexistence of AUD and AXD imposes a high burden via healthcare costs and lost productivity. To date, existing treatment approaches for addressing AUD/AXD comorbidity have been only modestly effective and there is a lack of adequate research to guide treatment decisions. The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has shown efficacy in treating emotional disorders. The efficacy of the UP to facilitate abstinence from alcohol consumption in individuals with comorbid AUD/AXD has also been examined, with results from this study indicating a reduction from baseline in drinks consumed per day. However, further evaluation of the UP for managing AUD/AXD is warranted. In this clinical trial, the investigators will further assess the UP's effectiveness in reducing alcohol consumption in patients with comorbid AUD/AXD. Participants will be randomized to one of two conditions: 1) treatment with the UP or 2) treatment with therapist-guided Take Control (TC; a computerized alcohol reduction program). In addition, in a subset of twenty-five participants, functional magnetic resonance scanning (fMRI) will be used to examine the effects of the UP on changes in brain activity in areas important to regulation of emotional and reward processes implicated in excessive alcohol consumption. The researchers' primary hypotheses are that the UP group will, compared to the TC group: 1) be superior in acute symptom reduction from pre- to post-treatment, and 2) evidence greater reductions in percent days heavy drinking, percent days of drinking per week, and alcohol craving.

Type: Interventional

Start Date: Mar 2018

open study