A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness...
Treatment Resistant DepressionObjectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.
Treating Depression With Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS)....
Mild-to-moderate DepressionOne multi-center, randomized controlled clinical trial is designed to examine whether transcutaneous electrical cranial-auricular acupoint stimulation (TECAS) is non-inferior to the antidepressant drug (Escitalopram) in treating mild-to-moderate depression, to evaluate the depressive subtypes who are suitable for the TECAS treatment. To achieve this objective, 470 patients with mild-to-moderate depression will be recruited and assigned to receive TECAS treatment (n =235) or Escitalopram (n =235, 10-20mg/day, q.d.) for 8 weeks. The primary outcome is the Montgomery-Åsberg Depression Rating Scale (MADRS); other outcomes include the17-item Hamilton Depression Scale (HAMD-17), the Hamilton Anxiety Rating Scale (HAMA), Pittsburgh sleep quality index (PSQI), the Short Form 36 Health Survey and TCM diagnosis of depression. In addition, the safety index will be measured throughout the whole study.
Efficacy of Convulsive Therapies During Continuation
DepressionBipolar Depression2 moreThis trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) and two different forms of electroconvulsive therapy (ECT) in sustaining response during and after a course of continuation treatment.
FaReWell Depression - Facial Exercise Program to Treat Depression
DepressionThis study investigates if a physiotherapeutic exercise program designed to relax facial muscles associated with the expression of negative emotions and to activate and strengthen facial muscles associated with the expression of positive emotions can reduce the symptoms of depression and improve wellbeing and quality of life in the affected patients.
NMDA Modulation in Major Depressive Disorder
Major Depressive DisorderMost of the current antidepressants for major depressive disorder (MDD) are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. NMDA hypofunction has been implicated in the pathophysiology of depression. Therefore, this study will examine the efficacy and safety as well as cognitive function improvement of an NMDA enhancer (NMDAE) in the treatment of MDD in the adults.
DBS for Depression
Treatment Resistant DepressionThe goal of this clinical trial is to demonstrate the feasibility and safety of deep brain stimulation in treatment resistant depression. The main questions it aims to answer are: Is deep brain stimulation effective in treating treatment resistant depression? Does deep brain stimulation improve overall clinical well-being and functioning? Participants will be implanted with a deep brain stimulation device. They will then be monitored over a 5-year period by using multiple questionnaires to track their depression symptoms. The device will be turned off at certain time points, unbeknown to the participant, to show the efficacy of the device when it is turned on. The device will be ON for 8.5 months and OFF for 3.5 months during the first year. Researchers will compare questionnaire scores when the device is off versus on to see if the device is working in reducing depression.
Ketamine as an Adjunctive Therapy for Major Depression (2)
Major Depressive EpisodeUnipolar Depression1 morePragmatic, randomised, controlled, parallel-group, superiority trial of ketamine vs. midazolam as an adjunctive therapy for depression. The main purpose of the trial is to assess the mood-rating score difference between ketamine and midazolam from before the first infusion to 24 hours after the final infusion, supplemented by a 95% confidence interval. There will also be a 24-week follow-up after the final infusion session.
Clinical Effectiveness of TARA Compared to Standard Treatment for Adolescents and Young Adults With...
Depression in AdolescenceDepressive Disorder1 moreDepressive Disorders constitute an increasing global health concern and available treatments for young people have not been sufficiently effective in haltering this trend. The novel group treatment program "Training for Awareness, Resilience, and Action" (TARA) was developed to target specific mechanisms based on neuroscientific findings in adolescent depression. TARA is framed within the National Institute of Mental Health's Research Domain Criteria and has documented feasibility and preliminary efficacy in adolescents with depression. In this study, young people (age: 15-22) with depression will be recruited from specialized Child and Adolescent Psychiatry and Youth Clinics and randomized to receive either TARA or Standard Treatment (ST) until n=67 is reached in each arm. Outcome measures will be obtained before randomization (T0), 6 weeks after treatment start (T0.5), at 3- and 6 months follow-up (T1, T2). The primary outcome measure is Reynold's Adolescent Depression Scale (RADS-2) score at T1. Secondary outcome measures are RADS-2-score at T2, clinician depression rating with Children's Depression Rating Scale, Revised at T1,and self-rated anxiety with Multidimensional Anxiety Scale for Children, 2nd ed. at T1 and T2. Other outcomes include heart rate variability and systemic bioindicators for depression from blood and hair. Data collected from subgroups within the study will include: brain magnetic resonance imaging and accelerometry. Qualitative interviews will be performed to reach a more comprehensive understanding of the subjective experience of being depressed and to what extent treatment adequately addresses this experience. A 2-year follow-up (T3) will be performed and presented separately. The study will be the first Randomized Controlled Trial to examine the clinical effectiveness of TARA compared to ST for young people with depression. The investigators hypothesize that (1) TARA will result in greater reduction of depression symptoms compared to ST and that group differences will be maintained or increased at T2, (2) the treatment effect of TARA will be mediated by improved emotion regulation, sleep, and psychological flexibility, (3) bioindicators for depression will improve more in the TARA-arm compared to the ST-arm, (4) it will be possible/meaningful to explore the contextual factors perceived to drive the depression onset and maintenance, and the extent to which the different treatments address these factors.
Comparing Effect and Change Processes in Cognitive Behavioral Therapy and Emotion-Focused Therapy...
DepressionDepression is a common mental illness which is costly for both society and for those affected. There is a need for effective treatments of depression and there is a need to make sure that the treatments that are given are based on scientific findings. In this study the investigators want to examine and compare two common treatment models for depression - Cognitive Behavioral Therapy and Emotion-Focused Therapy. The investigators want to investigate what characterizes these treatments when they are successful, and seek to better understand what it is like for patients to receive these treatments. Also, the investigators will investigate the experience of patients who abruptly discontinue treatment. To investigate these questions, self-report measures, interviews and analysis of session recordings will be used.
ICBT (Internet Based Cognitive Behavioral Therapy) for Maternal Depression: Community Implementation...
DepressionLow income women of childbearing age are at increased risk for depression and often do not receive needed treatment. Investigators developed Mom-Net, an on-line cognitive behavioral treatment (CBT) for depression to address the needs of low income women of childbearing age. The intervention program also includes live coaching to help the mothers engage and learn the CBT material. Mom-Net has been shown to be highly effective in reducing depressive symptoms and improving parenting behavior and child adjustment, in earlier controlled trials. In this project the investigators are examining whether access to Mom-Net can be expanded by delivering it in Head Starts (HS). To address that broad question, the investigators will focus on two sets of scientific questions: Implementation Questions: e.g., Can HS agencies deliver the program successfully; do HSs choose to sustain the program after the research project ends; what agency characteristics are associated with successful delivery of Mom-Net); Effectiveness Questions: e.g., Does Mom-Net reduce maternal depression when delivered by Head Start agencies, with HS staff doing the coaching? Head Start agencies will be randomized to deliver either Mom-Net with the usual high-intensity coaching or with a low-intensity coaching alternative. Within each agency, depressed mothers will be randomized to receive either: 1) Mom-Net program; or 2) Treatment as Usual (TAU;) referral to community mental health providers). Mothers initially assigned to the TAU condition, will have the option of receiving Mom-Net at a later date. Mothers will participate in assessments of depressive symptoms, parenting behavior, and child adjustment at Time 1 (T1; prior to randomization); and Time 2 (T2; after the intervention period) and Time 3 (T3; one year after T1).