View clinical trials related to Depressive Disorder.
Filter by:Project aim: To compare the effectiveness and acceptability of a conventional and a religious internet-supported cognitive behavior therapy (iCBT) for depression in Romania.
Low levels of vitamin D have been associated with depression. This study will test if a vitamin D supplement is helpful in patients with depression who have not found relief with the use of anti-depressant medication. Participants will continue to take their medication plus vitamin D or placebo for 8 weeks. The investigators will monitor their depression symptoms and the investigators think that the people taking vitamin D may have an improvement in their symptoms.
Background: - At least one third of individuals with major depressive disorder (MDD) remain treatment-refractory after receiving currently available antidepressants underscoring the urgent need for new antidepressant therapies. Of the novel pharmacotherapeutic strategies seeking to rapidly alleviate depressive symptoms, glutamatergic modulators have emerged as promising potential targets. The present study sought to examine the potassium (KATP) channel activator diazoxide as a possible treatment for MDD. Diazoxide increases glutamate uptake from the synaptic cleft by activating the KATP channel to chronically increase expression of the excitatory amino acid transporter (EAAT)-2 system in glial cells. Diazoxide is FDA-approved for the treatment of sulfonylurea-induced hypoglycemia, hypoglycemia due to hyperinsulinemia, and hypertension. Objectives: - To assess the ability of diazoxide, potassium channel activator, to improve overall depressive symptomatology in patients with treatment-resistant MDD currently experiencing a major depressive episode. The efficacy of a three-week course of diazoxide will be compared to three weeks of placebo. The MADRS will serve as the main outcome measure Eligibility: - Adults 18 to 65 years old with MDD who are currently depressed without psychotic features. Design: - Study Phase I (Day -28 to 0): -- Screen and taper off medications (Days -28 to -14): Prior to consenting to this study, subjects will have undergone a screening consisting of laboratory tests, psychiatric and medical history, and psychiatric and physical examinations under protocol 01-M-0254, "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers". After consenting to this study, patients will be tapered off medications. Medications allowed and not allowed are listed in Appendix 1. Patients will be reminded to report all drugs, OTC products, and other agents to the investigators so that they can screen to avoid interactions that might make participation unsafe or might confound the research results. Patients are expected to meet all inclusion and exclusion criteria before medications are tapered (which is usually 1-2 weeks long). Subjects who are not taking medications will enter the drug-free period directly. All participants must have a score of ≥20 on the MADRS at screening and baseline of Study Phase I. Subjects who do not have a score of ≥20 on the MADRS by the end of Study Phase I will be excluded and will receive standard treatment. - Drug-free period (Day -14 to day 0): -- Subjects will begin a 2-week drug-free period prior to the administration of diazoxide or placebo. - Study Phase II (Day 0 to 56): - In this study phase, subjects will be blindly randomized to receive either diazoxide 200-400 mg/day (given BID) or a placebo administered daily by mouth for three weeks. All patients except those who have a 50% or greater decrease in MADRS from baseline at the end of the first cross over point will cross over. To avoid carry-over effects between the different test sessions, there will be an interval of 14-21 days, pending response to test session 1. Subjects will then be blindly crossed over to the second experimental condition (either diazoxide or placebo) for another three weeks. All subjects who discontinue the study or who complete study phase II will then receive either clinical treatment or the opportunity to participate in another research protocol. Patients maintaining response to treatment condition 1 after two weeks will receive an additional one week washout before being crossed over to condition 2.The total duration of the study is approximately 11-13 weeks. The duration of Study Phase I including the 14-day drug-free period is approximately 4 weeks. Study phase II is 8-9 weeks long. Thus, the total duration of the study is approximately 11-13 weeks, except for those patients who were unmedicated at time of entry into the study and therefore do not need to undergo the initial tapering off medications. Subjects will be required to be hospitalized during the entire study. Passes will be permitted if the subject is clinically stable and the pass does not interfere with the study or unit procedures.
Low frequency rTMS (repetitive Transcranial Magnetic Stimulation) for the treatment of patients with depression, is responsible for a decrease in the expression of the C-FOS and DUSP1 genes in peripheral blood leukocytes. The decrease in C-FOS expression could be explained by the inhibiting effect of low-frequency rTMS (in contrast, high-frequency rTMS causes activation of the cerebral cortex) [Rossi, 2009]. This genetic effect could correlate with the antidepressant effect [Hausmann, 2000]. According to this hypothesis, the genetic effect related to medical antidepressant treatments deserves to be studied because we could observe: - either a decrease in the expression of the C-FOS and DUSP1 genes related to the antidepressant effect of the medical antidepressant treatment, - or an increase in the expression of the C-FOS and DUSP1 genes related to cerebral activation due to the medical antidepressant treatment. In summary, we wish to determine the validity of this hypothesis by comparing the genetic effect of rTMS with that of medical antidepressants to know if: - this genetic effect is specific to rTMS or common rTMS and medical antidepressants - this effect correlates with the clinical improvement induced by rTMS and by medical antidepressants - this early modification in the C-FOS and DUSP1 genes may be predictor of the therapeutic response to rTMS and antidepressants (early decrease in gene expression) - the absence of any decrease or increase in C-FOS and /or DUSP1 expression is a predictor of therapeutic resistance to rTMS and/or medical antidepressants.
The purpose of this study is to investigate the use of repetitive transcranial magnetic stimulation (rTMS) in helping to prevent relapse in major depressive disorder. rTMS is known to be an effective treatment for major depressive disorder, but there is also evidence that it may be effective in the maintenance of remission following treatment. However, it is not yet clear what maintenance strategy will yield the best outcome in preventing relapse. In this study, eligible patients who have finished one full course of rTMS for treatment of major depression will be randomized into three groups: (i) cluster rTMS, (ii) taper rTMS, and (iii) treatment as usual. The 'cluster rTMS' group will receive two weeks to daily rTMS six months after the completion of their regular rTMS treatment, the 'taper rTMS' group will receive three sessions a week for two weeks followed by two sessions a week for two weeks immediately following their regular rTMS treatment, while the 'treatment as usual' group will receive standard follow-up care from their own psychiatrist and/or primary care doctor. The investigators hypothesize that the group with cluster treatment will show significantly lower relapse rates in depressive symptoms as compared to the other groups.
According to the 2005 National Comorbidity Survey-Replication study, approximately 20.9 million American adults, or 9.5 percent of the population over the age of 18 suffer from mood disorders including major depressive disorder, chronic, mild depression and bipolar disorder. Major depressive disorder (MDD) is predicted to be the second leading cause of disability worldwide by the year 2020; sub-clinical mood disturbances impact many additional people and are a major reason people seek psychotherapy services. The economic burden of depression in the United States is significant: $83.1 billion in 2000 and increasing. Much of this burden comes from the high rate of sub-optimal treatment outcomes associated with the disorder. Indeed, only 50% of MDD patients recover in less than 12 weeks with adequate treatment, and up to 20% of patients will fail to adequately respond to all currently available interventions. Moreover, current treatments come at the cost of significant central nervous system (CNS) side effects, further highlighting the need for more effective treatments with fewer side effects. To address these pressing clinical issues, the investigators will conduct a placebo controlled, clinical trial to determine if Whole Body Hyperthermia (WBH) enhances the effects of psychotherapy compared to psychotherapy alone in medically healthy patients with moderate to severe mood disorders. The investigators plan to recruit a sample of 24 medically healthy individuals with mood problems who will be randomized to examine whether WBH enhances the effects of psychotherapy. To determine acute and sustained effects of WBH +psychotherapy on mood disorders, the study will include basic psychiatric questionnaire-based assessments at three therapy sessions prior to a single session conducted while receiving one of two intensities of WBH treatment. Subjects who elect not to conduct a therapy session in the WBH chamber will still be able to complete study questionnaires at all therapy sessions. This study challenges the existing paradigm by determining if peripheral afferent sensory pathways can be accessed to enhance the treatment of mood disorders and thus avoid problems of exposing all of the brain to non-selective drugs.
Depression and bipolar disorder are major public health concerns for adolescents today. Teenage depression and bipolar disorder are associated with social isolation, family stress, school failure, substance abuse and suicide. Screening for depression and bipolar disorder so that treatment can be started early in the course of illness is an urgent public health priority. Many teens with bipolar disorder are incorrectly diagnosed as having unipolar depression. It is critical that adolescents receive proper screening and assessment that leads to an accurate diagnosis and treatment. An efficient, cost-effective, blood-based screening program could be performed on an annual or semi-annual basis to potentially detect depression and then differentiate between unipolar and bipolar depression. If this type of screening were able to detect a significant percentage of teens with depression or bipolar disorder, the positive impact on U.S. public health would be substantial. The purpose of this study is to conduct a pilot study to assess the probability of detecting adolescent unipolar and bipolar depression through blood samples.
To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in patients with Major Depressive Disorder (MDD)
There is now overwhelming evidence documenting the efficacy of psychotherapy in the treatment of depression in the general population. Surprisingly, however, given the high prevalence of depression in cancer patients, there are very few studies on the efficacy of psychotherapy in this population. Published studies of psychotherapy in cancer patients generally include patients with high heterogeneity of psychiatric diagnosis and frequently include patients without a psychiatric diagnosis, with the aim of preventing the appearance of a psychiatric disorder. This heterogeneity complicates the interpretation of the efficacy and specificity of these interventions. Specifically, the efficacy of psychotherapy for major depression in patients with cancer is unknown.
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.