64 Clinical Trials for Various Conditions
The objective of this study is to collect data to finalize the development of MEB-001 software as a medical device. The data collected in this study will be used to develop MEB-001 machine learning algorithms by training the algorithms to match the patient's demographic and clinical information, and the objective physiological signals (i.e., electroencephalogram (EEG) and electrocardiogram (ECG)) recorded during PSG with the diagnosis of cMDE performed through the MINI neuropsychiatric evaluation.
This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression). Participants in the study will receive the drug being studied. This study is accepting male and female participants between 18 and 65 years old who have completed Study SEP380-301. This study will be conducted in approximately 90 study centers worldwide. The treatment duration for this study is one (1) year.
A clinical trial to study the efficacy and safety of an investigational drug in people with major depressive episodes associated with with Bipolar I disorder (bipolar I depression) Participants in the study will either receive the drug being studied or a placebo. The study will be conducted in approximately 90 sites in North America, Europe, Latin America and Japan. It will be have both male and female participants ages 18-65. Participation in the study will be approximately 10 weeks.
This is an open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in the treatment of participants with bipolar I/II disorder with a current major depressive episode.
A clinical study to test the effectiveness of an investigational drug to treat people that have major depressive episodes when they have Bipolar 1 Depression
Background: Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. It stimulates the brain. Researchers want to see if using magnetic resonance imaging (MRI) scans helps locate the best area for rTMS in each person. They also want to find other ways to make it more effective. Objective: To study the effects of combining MRI- guided transcranial magnetic stimulation (TMS) and talk therapy on the brain in people with depression. Eligibility: Adults ages 18-75 with a major depressive disorder and current depression. If taking an antidepressant, should have been doing so for at least 4 weeks. Design: Participants will be screened with medical and psychiatric history, psychiatric evaluation, physical exam, and blood and urine tests. Phase 1 is 1-4 visits in 1 week. Participants will have: * Brain MRI. Participants will lie on a table in a scanner. * Questions about their medical history and psychology symptoms * Tests of mood and thinking * Tests of brain activity. Participants may do tasks during these tests: * A cone with magnetic detectors is put on the head. * A cap with electrodes is put on the scalp. * TMS. A brief electrical current passes through a wire coil on the scalp. * A metal disk will be placed on the arm. A nerve will be stimulated with a small electrical shock. Phase 2 is about 6 to 7 weeks. * There will be 30 daily sessions of combined therapy and repetitive TMS (rTMS) for 6 weeks. * Participants will receive rTMS and another therapy by computer. * For rTMS, repeated pulses will pass through the coil. * This is followed by up to 3 additional visits, when: * Participants will repeat Phase 1 tests * Participants will rate their depression symptoms. Phase 3 is 3 visits over 3 months. Participants will rate their depression symptoms and repeat some of the previous questionnaires and tests of mood and thinking.
This is a retrospective chart review study to determine if Deplin® 7.5mg-15mg combined with an antidepressant is better than an antidepressant alone in adults with major depression.
The purpose of this study is to evaluate flexible doses (5-30 mg) of aripiprazole in patients with bipolar depression.
The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.
This study will evaluate a new form of non-invasive brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will be delivered using a range of stimulation parameters during psychological and physiological monitoring. Individualized optimal targets will be selected using structural MRI and diffusion tractography. Brain target engagement will be evaluated using functional MRI.
The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.
This is a randomized, double-blind, placebo-controlled pilot study aiming to evaluate the effects of NMRA-335140 on symptoms of major depression in adults with Bipolar (BP) II disorder. The study design consists of a Screening Period (up to 28 days), a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo), and a 6-week Safety Follow-up Period.
Development and preliminary testing of a text messaging intervention that will reduce the risk of a major depressive episode and worsening depressive symptoms in perinatal individuals. The system will screen pregnant individuals, send tailored text messages with links to enhanced content, and will include a peer chat function.This accessible text platform will leverage both the ease of use inherent in text messages and the power of enhanced content drawn evidence from based behavioral interventions (Interpersonal Therapy).
Severe depression is devastating for those affected and is often associated with significant risk of suicide. Electroconvulsive therapy (ECT) is a highly effective acute treatment for severe depression, but its use and acceptability are limited by cognitive side effects. Of these, retrograde memory loss is most concerning, and can be long-term. The introduction of ultrabrief right unilateral (UBRUL) ECT into clinical practice has been an important step in reducing the risk of memory impairment, but significant deficits still occur. A new form of UBRUL ECT which utilises a Frontoparietal electrode placement represents a further development. Preliminary data suggest that Frontoparietal UBRUL has good efficacy and less cognitive side effects than UBRUL given using the conventional Temporoparietal electrode placement. Designed as a pivotal trial, this protocol will be the first RCT comparing these two forms of ECT, producing the rigorous efficacy and safety data required to change clinical practice/policy. This is a multicentre, parallel group RCT with 1:1 allocation ratio between Frontoparietal (intervention) and Temporoparietal (comparator) forms of UBRUL ECT. Participation will involve receiving randomised acute ECT under blinded conditions during the randomised acute treatment period (typically around 4 weeks), then completion of a 24-week follow-up period which commences after the cessation of all acute ECT. The study protocol aims to provide 12 randomised acute ECT treatments, though the number of treatments (and hence the length of the randomised acute treatment period) can be adjusted by the participant's own treating/admitting psychiatrist according to their clinical judgement.
This study will evaluate a new form of non-invasive brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychological and physiological monitoring. A well-tolerated stimulation protocol will then be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial to evaluate brain target engagement using magnetic resonance imaging.
This neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) in reducing suicide risk in patients with major depressive episode (MDE) or borderline personality disorder (BPD).
This study will determine whether the Medibio Depression Diagnostic Aid exceeds minimally acceptable thresholds for sensitivity and sensitivity in cases with a current depression episode and non-depressed controls.
This study is designed to evaluate the safety and preliminary efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Bipolar Disorder type I in a Major Depressive Episode. This is an open label study in which subjects will receive treatment 5 days per week for 6 weeks.
This is a single-site open-label clinical trial of the Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT®) protocol. The goal of this clinical trial is to learn if a new form of transcranial magnetic stimulation (TMS)-known generally as accelerated intermittent theta burst stimulation (aiTBS) and specifically as SAINT®-is effective as a first-line therapy in treating adolescents aged 14-19 years-old in their first episode of depression who have not undergone a full course of depression treatment prior to starting the trial and who remain antidepressant-free throughout the trial. The main questions this trial aims to answer are: * Does SAINT® relieve symptoms of depression as a first-line therapy in adolescents? * Is SAINT® a feasible option as a first-line treatment for adolescent depression? Researchers will measure the depression symptoms in adolescent participants before and after SAINT®. Parents of the adolescent participant will also participate in the study providing information about their experience and preference for TMS as a first-line treatment. Adolescent participants will: * Remain antidepressant-free throughout the study period of 6-7 weeks. * Receive an MRI of their head for precision targeting * Receive 5 days of aiTBS (SAINT®)
Randomized, multi-site, sham-controlled, double-blinded study
Deficits in motivation and pleasure are common in depression, and thought to be caused by alterations in the ways in which the brain anticipates, evaluates, and adaptively uses reward-related information. However, reward processing is a complex, multi-circuit phenomenon, and the precise neural mechanisms that contribute to the absence or reduction of pleasure and motivation are not well understood. Variation in the clinical presentation of depression has long been a rule rather than an exception, including individual variation in symptoms, severity, and treatment response. This heterogeneity complicates understanding of depression and thwarts progress toward disease classification and treatment planning. Discovery of depression-specific biomarkers that account for neurobiological variation that presumably underlies distinct clinical manifestations is critical to this larger effort.
The purpose of this study is to examine the effects of interventional/procedural therapies for treatment-resistant depression (TRD) and Obsessive-Compulsive Disorder (OCD). These treatments include electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), racemic ketamine infusion and intranasal esketamine insufflation. The investigators will obtain various indicators, or biomarkers, of a depressed individuals' state before, during, and/or after these treatments. Such biomarkers include neurobehavioral testing, neuroimaging, electroencephalography, cognitive testing, vocal recordings, epi/genetic testing, and autonomic nervous system measures (i.e. "fight-or-flight" response). The results obtained from this study may provide novel antidepressant treatment response biomarkers, with the future goal of targeting a given treatment to an individual patient ("personalized medicine").
The primary goal of the proposed study is to compare the effectiveness of universal school based screening for adolescent major depressive disorder to the current school process of targeted screening based on concerning behavior.
This multi-site, double-blind, randomized, sham-controlled mechanistic trial aims to test the effects of Magnus Neuromodulation System (MNS) with Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT®) Technology on the neural circuitry of suicidal cognitions in psychiatrically hospitalized patients with Major Depressive Disorder (MDD) and active suicidal ideation (SI). This will be accomplished by applying the MNS with SAINT to a customized target within the left dorsolateral prefrontal cortex (L-DLPFC) identified with fMRI for five consecutive days and measuring resting-state functional connectivity (RS FC) between the subgenual anterior cingulate cortex (sgACC) and the default mode network (DMN) at baseline and immediate-post visit. The relationship between changes in RS FC and changes in both Explicit and Implicit Suicidal Cognitions (ESC and ISC, respectively) will be determined. This study will also determine the relationship between changes in RS FC in neural networks underlying mediators of suicidal cognitions and changes in such mediators with active versus sham SAINT.
Lithium is highly effective in the treatment of bipolar disorder. This study aims to investigate, for the first time, the impact of lithium monotherapy on the structural and functional connectivity of the brain using MRI imaging.
We hope to demonstrate that magnetic resonance spectroscopy can detect brain concentration levels of paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) in depressed patients.
The goal of the study is to conduct a comparative randomized trial of electroconvulsive therapy (ECT) vs. ketamine for patients with treatment resistant depression (TRD) in a real world setting with patient reported outcomes as primary and secondary outcome measures.
This research study will examine if a targeted computerized cognitive remediation (CCR) training program is better for treating geriatric depression than general computer activity. We will also examine whether this intervention is related to improvement in cognitive and depressive symptoms. Elderly patients with depression, who have, and who have not been treated with antidepressant medication for their illness, will be recruited to participate in either a 30 hour cognitive remediation program or general computer activity designed to be both challenging and interesting. They will be asked to complete between 1 and 3 hours of remediation per day over 4 weeks. While undergoing the cognitive remediation participants will be asked questions to assess their symptoms of, as well as the severity of, their depression weekly. This will inform researchers about whether or not the CCR is helping to improve depressive symptoms. At the end of the CCR study, participants will be given a battery of cognitive tests design to tell investigators whether or not the CCR improved their thinking in a variety of different ways including improving attention, memory, and organization. Investigators will also determine whether changes in participants' thinking are related to changes in their mood or other depressive symptoms. It is hoped that information gained from this study will help investigators to better understand the brain processes associated with depression, recovery from depression, and will help inform the development of future alternative treatments for this illness.
This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar depression. The first drug, ketamine, is an experimental antidepressant that early studies have shown may quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the comparison drug, is not thought to reduce depression or suicidal thoughts.
To evaluate the feasibility, tolerability and efficacy of Magnetic Seizure Therapy (MST) in elderly patients with a major depressive episode, who are randomly assigned to receive an acute course of MST or ECT. The investigators hypothesize: 1. MST and ECT will have similar antidepressant efficacy 2. MST will have less post-treatment amnesia than ECT as reflected in a primary measures of anterograde and retrograde amnesia following the acute treatment phase. 3. At follow up, MST will show a lesser degree of persisting deficit in measures of retrograde amnesia than ECT.