Active clinical trials for "Depression"

This study follows children into adolescence who were first randomized to intervention condition in infancy.

In Canada, approximately 20% of patients with Major Depressive Disorder (MDD) have treatment-resistance and fail to respond to trials of pharmacotherapy or psychotherapy. Although the treatment of choice has historically consisted of electroconvulsive therapy (ECT), this is not always feasible or practical, and carries a risk of side-effects that may be unacceptable to certain patients. In this pragmatic, multi-site, placebo-controlled and double-blinded clinical trial, participants with ultra treatment-resistant MDD will be randomized to receive either active or sham transcranial direct current stimulation in addition to their usual treatment. Ultra treatment-resistant depression will be operationally defined as MDD that has failed to respond to at least five previous trials of antidepressants at sufficient doses, or ECT, or ketamine. Patients will receive a total of 30 active or sham treatment sessions (5 per week), for 30 minutes per session. In both groups, the anode will be placed over the left dorsolateral prefrontal cortex (position F3), and the cathode over the right dorsolateral prefrontal cortex (position F4). Patients in the sham group will receive electrical stimulation at 2 mA for less than 30 seconds, whereas patients in the active group will receive that level of stimulation for the entire duration of treatment. The study's primary outcome is the change in score on a clinician-graded depression inventory (the Montgomery-Asberg Depression Rating Scales). Secondary outcomes include change in scores on a self-administered depression rating scale and measurement of function scale. Information on language ability will also be collected, as will data on side-effects of treatment. Scores will be collected before the trial start, after every 10 sessions, and one month after trial completion.

In West Africa, most people with serious mental illness receive care from traditional or faith healers at prayer camps. The stepped-wedge cluster randomized trial aims to evaluate the effectiveness of a dual-pronged intervention package comprised of a mobile health program designed to train healers to deliver evidence-based psychosocial interventions combined with pharmacotherapy delivered directly to the patients at their prayer camps via a visiting nurse in Ghana.

Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease-including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. Lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in ART. As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care, and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes. The investigators will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9). Rollout will follow a stepped-wedge cluster randomized design in which 14 health facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g. HIV: viral load, ART adherence; diabetes: A1C levels, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every three months through 12-month follow-up. The investigators will also evaluate the model's cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model. This study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. The investigators will also look at the indirect effects of the intervention at the household level. The investigators' hypothesis is that the intervention will be effective at reducing depression symptoms, improving physical health, and improving household members' wellbeing, compare to treatment as usual. The investigators also hypothesize that the intervention will be highly cost-effective, meaning that the cost per QALY gained will be less than Malawi's median GDP per capita. If determined to be effective and cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence.

Posttraumatic stress disorder (PTSD) is a major public health concern that disproportionately effects minorities and those with low-socioeconomic status, such as homeless women, creating a critical health disparity. PTSD has been linked with dysregulated hypothalamic-pituitary-adrenal (HPA) functioning and increased inflammation, which can lead to long-term physical-health problems and PTSD-symptom maintenance, exacerbating disparities. Mindfulness-based interventions, including Mindfulness-based Stress Reduction (MBSR), have shown promise as a complementary tool for addressing PTSD in veterans and with low-income, minority populations, but homeless women have not been examined adequately. MBSR may improve PTSD symptomatology and help modulate the dysregulated stress response common in individuals with PTSD, improving physical and mental health concurrently. This project is an open-label, parallel, modified-cross over clinical trial of a modified-MBSR intervention to reduce PTSD symptoms in homeless women and to explore physiological correlates of treatment-response. Hypotheses: Participation in an MBSR-based intervention will be associated with clinically significant reduction in PTSD (primary outcome), lower depression symptoms and greater drug and alcohol abstinence (secondary outcomes) compared to participation in an attention control. Compared to an attention control, participants in an MBSR-based intervention group will demonstrate improvements in cortisol reactivity and lower inflammation. At baseline, women will complete psychosocial assessments (e.g., depression, substance use, trauma history) and participate in a brief stress task, providing salivary samples before and after the task (which will be assayed for cortisol and C-reactive protein, a marker of inflammation). Women will then participate in 1) a 9-session MBSR-based program that was modified based on an initial qualitative component that involved a Community Advisory Board and focus groups with women from the community (N=4 focus groups; 28 women total) or 2) a nine-session health-promotion course (i.e., attention-control condition). Follow-up assessments that include psychosocial and biological data will occur immediately after final intervention session and again 6-months later. Clinically-meaningful improvements in PTSD (primary outcome) and secondary outcomes (e.g., depression, substance use, inflammation, cortisol reactivity) will be examined.

Therapeutic latency, lack of efficacy, and adverse drug reactions are the major concerns in current antidepressant therapies. One-third of the patients with major depressive disorder do not respond to conventional antidepressants that act through the monoaminergic system. To overcome these treatment hurdles, add-on therapy to standard antidepressant drugs may lead to better therapeutic outcomes. The recent discovery of the rapid and sustained antidepressant effect of subanesthetic dose of ketamine led to many extensive clinical and preclinical research in the recent past and has established the possibilities of NMDA receptors as a potential drug target for depression. As repeated doses of ketamine are related to abusive potential and adverse effects, the search for a similar antidepressant agent with a better safety profile is essential. Dextromethorphan has the property of noncompetitively blocking N-methyl-D-aspartate receptors (like ketamine) with additional serotonin transporter and norepinephrine transporter inhibitory action. So, the investigators expect that adding dextromethorphan to selective serotonin reuptake inhibitors (SSRIs) regimen can improve clinical outcomes in major depressive disorder. The literature search found that to date, there is no randomized controlled trial on Dextromethorphan as add-on therapy to first-line antidepressants like SSRIs. So, the present randomized controlled trial has been planned to evaluate the efficacy and safety of add-on dextromethorphan to SSRIs in major depressive disorder.

Objective: Chronic epidural cortical stimulation (ECS) involves the neurosurgical placement of an electric wire on the surface of the brain with intermittent activation. Over time, ECS modulates local and distal connected brain regions. It is being currently applied over the motor cortex to treat intractable pain. Because of the important role played by the medial prefrontal cortex in mood regulation, the goal of this study is to apply this minimally invasive neurostimulation modality over medial prefrontal cortex in severely ill depressed subjects who have failed all other attempts at treatment.

To examine the effectiveness and clinical care outcomes of cognitive-behavioral therapy interventions at Massachusetts General Hospital (MGH).

This is an open label pilot feasibility study that will recruit 15 participants. The purpose of the pilot study will be to evaluate the feasibility of open label Transcranial direct current stimulation (tDCS) in combination with computerized cognitive behavior therapy (cCBT) to maintain wellness following an acute course of Electroconvulsive therapy (ECT) for up to 6 months.

The investigators are conducting a comparative effectiveness trial among adult patients with sickle cell disease (SCD) who report chronic pain (N = 350), randomized to receive either mobile phone-delivered computerized cognitive behavioral therapy (cCBT; n = 175) or digital education (m-Education; n = 175). Both intervention groups will receive weekly (more frequent if requested or needed) follow-up with a health coach for at least 3 months to reinforce learned materials. Both groups will also use their mobile device to track daily pain, mood, and medication used for two-week periods at baseline and each of the follow-up points (3, 6 and 12 months). Participants will also be given access to a study-associated online support group page where members can discuss with other patients, issues participants faced and what skills were or could be used to address them. Participants will continue all routine care including opioid pain management and novel therapies.