Active clinical trials for "Depressive Disorder"

Major depressive disorder (MDD) is a common psychiatric condition, mostly treated with antidepressant drugs, which are limited for issues such as refractoriness and adverse effects. In this context, the investigators investigate a non-pharmacological treatment known as transcranial direct current stimulation (tDCS). To prove that tDCS is similarly effective than antidepressants would have a tremendous impact in clinical psychiatry, since tDCS is virtually absent of adverse effects. Its ease of use, portability and low price are also interesting characteristics for using in primary and secondary health care. Thus, our aim is to compare tDCS against a fully dosed, effective antidepressant. The study will be a non-inferiority, randomized, double-blinded, placebo-controlled, three-arm trial comparing active tDCS/placebo pill, sham tDCS/escitalopram 20mg/day and sham tDCS/placebo pill. Our primary aim is to show that tDCS is not inferior to escitalopram 20mg/day with a noninferiority margin of at least 50% of the escitalopram-placebo effect.

This study is evaluating the effects of two brain training exercises on: memory, cognitive processing and depression symptoms.

This is a double-blind, randomized, sham-controlled phase II study of the effects of Low Field Magnetic Stimulation (LFMS) on brain circuitry of adults with treatment-resistant Major Depressive Disorder (MDD). Eligible subjects will be randomly assigned to double-blind treatment with three 20 minute sessions of either (1) active LFMS or (2) sham LFMS. Resting state fMRI will be performed at baseline and following the third and final treatment session.

This project seeks to elucidate the mechanisms by which antidepressant medications have limited efficacy in Late Life Depression (LLD) in order to develop new treatment interventions for this prevalent and disabling illness. Investigators hypothesize that the presence of executive dysfunction (ED),which is common in depressed adults over 60, impairs the ability to form appropriate expectancies of improvement with antidepressant treatment. Greater expectancy has been shown to improve antidepressant treatment outcome and is hypothesized to be a primary mechanism of placebo effects. Moreover, white matter hyperintensities (WMH) on magnetic resonance imaging (MRI) are more prevalent in patients with LLD compared to healthy controls. It has been argued that WMH contribute to the pathogenesis of LLD with ED and decrease the efficacy of antidepressant medications by disrupting connections between prefrontal cortical (PFC) and subcortical structures. Vascular lesions to white matter tracts may also compromise the pathway by which expectancy-based placebo effects influence depressive symptoms. Expectancies reflect activation in PFC areas that may improve depressive symptoms by modulating the activity of subcortical regions subserving negative affective systems (i.e., amygdala) as well as those important in reward and hedonic capacity (nucleus accumbens and ventral striatum). Thus, LLD patients with ED and WMH may sustain a "double-hit" to their ability to experience placebo effects in antidepressant treatments: ED diminishes the ability to generate appropriate treatment expectancies, while WMH disrupt the physiologic pathways by which expectancies lead to improvement in depressive symptoms.

Observational evidence and findings from clinical trials conducted for other reasons suggest that lithium, a drug used for the treatment of bipolar disorder, and, to a lesser extent, depression, may reduce rates of suicides and suicide attempts. However, this hypothesis has not yet been adequately examined in a randomized clinical trial conducted specifically to test lithium's efficacy in preventing suicides. This clinical trial fills this gap. This study is feasible within the Department of Veterans Affairs (VA) because it is a large, integrated health system with existing programs for identifying patients at risk for suicide and delivering enhanced services. In VA, approximately 12,000 patients with depression or bipolar disorder survive a suicide attempt or related behavior each year, and 15% of them repeat within one year. Experimental treatment in this study will supplement usual care for major depression or bipolar disorder, as well as VA's standard, enhanced management for patients at high risk. The investigators will recruit 1862 study participants, from approximately 30 VA Hospitals. Participants will be patients with bipolar disorder or depression who have survived a recent episode of suicidal self-directed violence or were hospitalized specifically to prevent suicide. Randomly, half will receive lithium, and half will receive placebo. Neither the patients nor their doctors will know whether a particular person has received lithium or placebo. The treatment will be administered and the patients will be followed for one year, after which patients will go back to usual care. Recruitment will occur over 3 years. The investigators are primarily interested in whether lithium leads to increases in the time to the first repeated episode of suicidal behavior, including suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide. In addition, this study will allow us to explore whether lithium decreases the total number of suicidal behaviors, and whether it has comparable effects on impulsive and non-impulsive behaviors. If there is an effect of lithium, the investigators will be interested in whether or not it could be attributed to improved control of the underlying mental health condition, or, alternatively, whether it represents a direct effect of suicide-related behavior.

Objectives: To demonstrate the duration of the antidepressant effect of Low Field Magnetic Stimulation (LFMS)in subjects with bipolar depression. Hypotheses: Investigators expect subjects who receive LFMS to show significant mood improvement one week after the start of a three day course of daily stimulation as compared to subjects who receive sham LFMS. Investigators expect subjects who receive LFMS to show immediate mood improvement over the first treatment as measured by the difference in pre and post-treatment PANAS+ ratings. Investigators expect to show that LFMS will be well tolerated in a three-treatment protocol.

Standard treatments for depression in specialty care settings are effective but resources for delivering empirically supported psychotherapies are often limited. Computerized cognitive behavioral therapy (cCBT) is an effective and highly scalable treatment for depression that might help expand services in psychiatric settings, however, little is known about its efficacy in this population. The present study aims to establish the efficacy of a internet-delivered cCBT program ("Beating the Blues") plus email and telephone support for depression in a psychiatric outpatient clinic setting. The secondary aim is to pilot an assessment procedure designed to identify moderators of treatment effectiveness.

Background The rates of perinatal depression in South Asian women are reported to be amongst the highest in the world, ranging from 18%-30% in urban areas and 28%-36% in rural areas. In addition to its profound impact on women's health, disability and functioning, perinatal depression is associated with poor child health outcomes such as pre-term birth, infant under-nutrition and stunting. There is robust evidence that perinatal depression can be effectively managed with psychological treatments delivered by non-specialist health care workers. The Thinking Healthy Program (THP), a psychological treatment delivered by community health workers (CHWs) in Pakistan, more than halved the rate of perinatal depression among mothers and led to significant improvements in child health outcomes. To enhance access to such evidence-based psychological treatments there is a need to examine the potential role of other human resources such as lay persons in delivering psychological treatments such as THP in poor resource settings. Objective To evaluate the effectiveness and cost-effectiveness of THP delivered by peers (the Thinking Healthy Program-Peer delivered in Goa, India; THPP-I) over the duration of 6 months. Peers will be healthy mothers who live in the same community as potential trial participants (TPs). Study design and outcomes Individual randomized controlled trial in Goa, India involving 280 women. TPs will not be blinded to treatment allocation. Mothers attending antenatal clinics at hospitals will be assessed for eligibility to participate in the trial (e.g. whether they are in the second or third trimester of pregnancy). Those who are eligible will be invited to participate in screening for depression; mothers who consent will be screened for depression with a locally validated version of the Patient Health Questionnaire (PHQ-9). Women who screen positive (PHQ-9 score ≥ 10) and give informed consent for further participation in the trial will be randomly allocated in a 1:1 ratio to receive enhanced usual care (EUC) or THPP-I+EUC, using a computer generated allocation sequence. The primary outcomes will be remission (i.e. recovery from depression and depressive symptoms), both assessed by the PHQ-9 at 6 months. Secondary outcomes are depressive symptoms and remission at 3 months (PHQ-9), maternal disability at 3 and 6 months (measured with the WHO-DAS), perceived social support, breastfeeding rates and infant weight and height of children at 3 and 6 months. Outcomes will be analyzed on an intention to treat basis. Interventions EUC will comprise communicating the results of the screening to the mother through an information sheet on self-care for mental health, communicating the results to the mother's gynaecologist, providing the gynaecologist with the WHO mhGAP guidelines for the treatment of depression, and providing guidance on referral of depressed mothers to mental health services. TPs who are in the THPP-I group will receive, in addition to EUC, between 6 to 14 sessions of THPP starting from their recruitment in the second/ third trimester until up to 6 months after child birth. Sessions will be delivered by peers on an individual basis at a location of convenience to the TPs (usually at their own homes). Implications THPP-I has the potential to advance knowledge of the extent to which task-shifting of the delivery of evidence-based psychological treatments can be extended to peers in the community. If effectiveness is observed, this approach offers a potential opportunity to access a vast untapped human resource for maternal mental health care and addresses a major barrier in global mental health - the lack of skilled and motivated human resources in the formal health sector - offering a new avenue for the scaling up of evidence-based psychological treatments and mental health services in low resourced settings.

The study's primary goal is to assess the effectiveness of behavioural activation in reducing depressive symptoms and re-integrate patients with depression into their personal and professional lives thus improving quality of life and helping in attaining and maintaining remission of depression. It is aimed at helping patients re-engage with several life areas that they may have lost in the course of depressive illness. The intervention is centred on behavioural activation (BA) with complementary interventions including recreation activities, and behavioural modifications. The study question is: in patients with depressive disorder attending a specialized hospital based mood disorders clinic, does the addition of behavioural activation program delivered in a group format improve depressive symptoms and quality of life compared to treatment as usual after 18 weeks of treatment? Study investigators hypothesize that behavioural activation is an effective treatment for depressive disorder in patients with depression.

Since a few years, Mindfulness Based Cognitive Therapy (MBCT) has been used as treatment for patients suffering from recurrent depression. Though a number of studies show that MBCT is effective in this population and MBCT reduces the chances of relapse/recurrence in recurrent depressive patients, the chance of a new depression developing after end of treatment is still considerable. Ergo, there is room for improvement. Especially the development of a non-judging or compassionate attitude towards all experience seems to mediate the treatment effect. It is therefore our expectation that a follow-up intervention that focuses specifically on self-compassion could prove very useful in elaborating on the effects of MBCT. The research question of this research is therefore: what is the effect of compassion training in people suffering from recurrent depression who have already received MBCT training?