Title: Safety and Feasibility of Individualized Low Amplitude Seizure Therapy (iLAST)
Unipolar DepressionBackground: Electroconvulsive therapy (ECT) is used to treat people with severe depression. During ECT, the brain is given electric pulses that cause a seizure. Although it is effective, it can cause side effects, including memory loss. Researchers want to study a new way to give ECT called iLAST. Objective: To see if iLAST is safe and feasible in treating depression. Eligibility: People ages 22 70 years old who have major depressive disorder and are eligible for ECT Design: Participants will be screened under protocol 01-M-0254. This includes: Medical and psychiatric history and exam Blood and urine tests Participants will be inpatients at the Clinical Center. They study has 3 phases and will last up to 20 weeks. Phase I will last 1 week. It includes: MRI: Participants will lie in a scanner that takes pictures of the body MEG: A cone over the participant s head will record brain activity. TMS: A wire coil placed on the participant s scalp will produce an electrical current to affect brain activity. SEP: An electrode on the participant s wrist will give a small electrical shock to test nerve function. Phase II will last 2 and a half weeks. It includes: Seven sessions of iLAST under general anesthesia. Participants may also get standard ECT. EEG: A small electrode placed on the participant s scalp will record brain waves. Interviews about mood, symptoms, and side effects. Participants facial expressions may be video recorded. TMS Phase III will last at least 1 week. It will include: MRI EEG TMS MEG Standard ECT if needed. Participants will have sessions every other day, 3 times a week. Sponsoring Institution: National Institute of Mental Health ...
Whole-body Hyperthermia for Mild to Moderate Depressive Disorder
DepressionUnipolarThe primary aim of this study is to investigate the effectiveness of whole-body hyperthermia in comparison to wait list on depressive symptom severity in patients with mild to moderate depressive disorder currently not under psychotherapeutic or antidepressant drug treatment. Secondary aims included further quality of life outcomes, immunological parameters, and tolerability/safety of the hyperthermia.
Effectiveness of an Integrated Treatment to Address Smoking Cessation and Anxiety/ Depression in...
Human Immunodeficiency VirusSmoking Cessation6 moreSmokers living with HIV represent a major health disparity population in the United States and the world more generally. Major contributing factors to the maintenance and relapse of smoking among smokers living with HIV include increased exposure to multiple stressors associated with HIV, which often exacerbates anxiety/depression. In a previous project, the feasibility, acceptability, and initial efficacy of a 9-session, cognitive-behavioral-based intervention to address smoking cessation by reducing anxiety and depression via specific emotional vulnerabilities (anxiety sensitivity, distress tolerance, and anhedonia) was tested against an enhanced standard of care in a pilot randomized controlled trial (NCT01393301). It was found that when compared to a brief enhanced treatment as usual control, patients in the intervention achieved higher short-term and long-term smoking abstinence rates. In this project, the investigators seek to test this same intervention in a fully powered, 3-arm efficacy/effectiveness trial. The goal of this study is to randomize 180 smokers across three sites to test the efficacy/effectiveness of the intervention at increasing point prevalence abstinence by reducing anxiety and depression at a 1-month follow-up (the end of treatment timepoint/ approximately 1-month post quit day) and a 6-month follow-up (approximately 6-months post quit day).
Testing TRUST Depression Management Intervention
DepressionQuality of LifeThis study evaluates the effectiveness of a novel depression management intervention in adolescents with depression. Half of participants will receive a traditional depression management intervention, wile the other half will receive the novel depression management intervention.
Do Omega-3 Fatty Acids Have an Antidepressant Effect in Patients With Signs of Peripheral Inflammation?...
Major Depressive DisorderIn this study, the investigators will stratify depressed subjects a priori based on CRP levels to test the hypothesis that eicosapentaenoic (EPA) would be more efficacious to treat depression in subjects with high CRP levels compared to subjects with low CRP levels. Depressed subjects, with ongoing stabilized antidepressive treatment who remain clinically depressed, will be enrolled in an "Inflammation group" or in a "Non-inflammation group" depending on baseline levels of CRP. Subjects in both groups will receive EPA enriched omega-3 fatty acids for 8 weeks, added to their pre-stabilized antidepressant medication.
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine...
Healthy VolunteerMajor Depressive Disorder1 moreBackground: Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For most people, this lasts a week or less. Repeated doses of ketamine may help maintain this effect. Objective: Main Study: To study the effects of ketamine in treating depression. Ketamine Metabolites Substudy: To study how ketamine effects brain chemistry. To study how ketamine effects the brain. This is done by looking at metabolites, which are created when a drug is broken down. Eligibility: Main Study: People ages 18-65 with major depressive disorder and healthy volunteers Ketamine Metabolites Substudy: Healthy volunteers ages 18-65 Design: Main Study: Participants will be screened in another study, with: Medical and psychiatric history Psychiatric and physical exam Blood, urine, and heart tests Participants will be inpatients at NIH for 4 phases totaling 14-20 weeks. Phase I (2-7 weeks): Gradually stop current medications MRI: Participants lie and perform tasks in a machine that takes pictures of the body. Mood and thinking tests Blood and urine tests Sleep test: Monitors on the skin record brain waves, breathing, heart rate, and movement during sleep. Transcranial magnetic stimulation: A coil on the scalp gives an electrical current that affects brain activity. Stress tests: Electrodes on the skin measure reactions to loud noises or electric shocks. Phase I tests are repeated in Phases II and III and in the final visit. Phase II (4-5 weeks): 4 weekly IV infusions of ketamine or a placebo during an MRI or MEG. For the MEG, a cone over the head records brain activity. Phase III (optional): 8 infusions of ketamine over 4 weeks Phase IV (optional): Symptoms monitoring for 4 weeks Participants will have a final visit. They will be offered standard treatment at NIH for up to 2 months. Ketamine Metabolites Substudy: Participants will be screened in another study, with: Medical and psychiatric history Psychiatric and physical exam Blood, urine, and heart tests Participants will be inpatients at NIH for 4 days. Study Procedures: Mood and thinking tests Blood and urine tests 1 infusion of ketamine Spinal tap and spinal catheter: Used to get samples of cerebrospinal fluid (CSF). This is a fluid that moves around and within the brain and spinal cord. Studying CSF will help us learn how ketamine effects brain chemistry
NRX101 for Suicidal Treatment Resistant Bipolar Depression
Bipolar DepressionSuicidal Ideation and BehaviorNMDA antagonist drugs have shown to reduce symptoms of depression and suicidal ideation. NeuroRx has developed NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for oral use in the treatment of bipolar depression with suicidal ideation. This study will test the hypothesis that NRX-101 is superior to lurasidone alone (standard of care) in maintaining remission from symptoms of depression (primary endpoint) and suicidal ideation or behavior (declared secondary endpoint) over a six week period of twice-daily oral dosing.
A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
DepressionBipolarThis is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or inpatients) with type I or II bipolar disorder accompanied by major depressive episode, without any psychotropic features. This study involves patients who are considered by the investigator not to have a proper improvement, despite receiving a mood stabilizer (lithium or valproic acid) for a sufficient (≥ 28 days) period of time during the current depressive episode.
Sleep Subtypes in Adolescent Depression
Major Depressive DisorderThe purpose of this study is to compare sleep neurophysiology and behavior in adolescents with MDD with hypersomnia (MDD-HYP) and insomnia (MDD-INS) with healthy controls (HC). In addition, the investigators will test the efficacy of a simple behavioral sleep restriction on mood and sleep in their sample.
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder...
Major Depressive DisorderThis is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.