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Depressive Disorder clinical trials

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NCT ID: NCT03548545 Recruiting - Clinical trials for Major Depressive Disorder

tDCS as add-on Treatment to Cognitive-Behavior Therapy in People With MDD

ESAP
Start date: March 28, 2018
Phase: N/A
Study type: Interventional

This is a parallel randomized, double-blinded, sham-controlled clinical trial in which a total of 72 drug-naïve MDD subjects (36 per arm) are randomized to one of two groups: Cognitive-Behavior Therapy (CBT) combined with either active or sham tDCS. The primary outcome is mood improvement, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). The secondary outcome is to test whether tDCS combined with CBT can engage the proposed mechanistic target, of restoring the prefrontal imbalance and connectivity, by changes over EEG.

NCT ID: NCT03522545 Recruiting - Clinical trials for Treatment-resistant Bipolar Depression

Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression

Start date: April 20, 2022
Phase: Phase 1
Study type: Interventional

The overall objective of the investigators is to assess the therapeutic efficacy and tolerability of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow for treatment of treatment-resistant bipolar depression patient (TRBD).

NCT ID: NCT03518749 Recruiting - Depression Unipolar Clinical Trials

Effects of tDCS-enhanced Cognitive Control Training on Depression

Start date: March 19, 2018
Phase: N/A
Study type: Interventional

Deficient cognitive control (CC) is one of the central characteristics of major depression (MD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) has been linked with this deficit. Antidepressants and cognitive-behavioral therapies modify CC most-likely as a common mechanism of treatment. Transcranial direct current stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the cortical excitability. It has been shown, that the activity of the dlPFC can be modulated by transcranial direct current stimulation (tDCS) with polarity-dependent learning-phase specific effects on performance that, when combined with training, can outlast the stimulation. The goal of this randomized, sham-controlled, rater blind clinical trial is to investigate the effect of a tDCS-enhanced CC Training (CCT) on depressive symptom severity and compare the stimulation intensities 1mA, 2mA and sham tDCS. Overall, the study will include 57 participants (n = 19 per group). Each participant will complete 12 training sessions with online sham/ anodal tDCS. As a training task we will use an adaptive version of the paced auditory serial addition task (PASAT). In the PASAT, digits are presented auditive and participants have to add the current digit to the digit they heard before. In the adaptive version the interstimulus-intervals decrease (increase) when four consecutive trials are correct (incorrect). The PASAT is known to elicit frustration. Participants have to exert cognitive control over these emotions to complete the task successfully. Before, during and after the training symptom severity will be assessed. Baseline and post-training performance in the PASAT and in a transfer task (delayed working memory task, DWM) will be measured. To further explore variables that influence the effect of tDCS on depressive symptom severity we will measure brain activity (EEG, NIRS), heart rate, global functioning (GAF), emotion regulation strategies, self-esteem, mood ratings and subjective performance ratings before and after the training and collect genetic factors. Sustainability of the training effects will be measured at a follow-up visit (3 months later).

NCT ID: NCT03509077 Recruiting - Depressive Disorder Clinical Trials

Study of Addiction Criteria in the Elderly

CAPA
Start date: June 19, 2018
Phase:
Study type: Observational

Patients over 65 years old who are exposed to alcohol or benzodiazepines will be recruited through the Fragility Assessment and Addictions Prevention Day Hospital, the Addiction Service and the Geriatric Post-Emergency Department. Toulouse University Hospital. The investigators will study descriptively the frequency of substance use disorder and the frequency of DSM-5 criteria associated with this diagnosis in a population of elderly subjects.

NCT ID: NCT03505905 Recruiting - Clinical trials for Major Depressive Disorder

A Neurosteroid Intervention for Menopausal and Perimenopausal Depression

Start date: September 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

HYPOTHESIS: Pregnenolone administration will be associated with greater reduction in depressive symptom severity than placebo in women with current mMDD. STUDY AIMS: Primary Aim: Determine if pregnenolone is associated with greater reduction in depressive symptom severity than placebo in women with mMDD, as measured by MADRS. Secondary Aims: 1. Determine if pregnenolone is associated with greater reduction in anxiety symptom severity than placebo in women with mMDD. 2. Determine if pregnenolone is associated with greater improvement in cognition than placebo in women with mMDD. 3. Determine if pregnenolone is associated with greater improvement in quality of life than placebo in women with mMDD. 4. Determine if pregnenolone is associated with greater improvement in vasomotor symptoms of menopause than placebo. Mechanistic Aims: 1. Determine whether changes in neurosteroid levels with pregnenolone mediate clinical response. 2. Determine if baseline neurosteroid levels predict pregnenolone response. 3. Determine whether depressive symptoms, anxiety, sleep or vasomotor symptoms improve first. A crossed-lagged panel model will explore serial correlations between changes in outcome measures.

NCT ID: NCT03500029 Recruiting - Depression Clinical Trials

The Study About Mechanism of Transcranial Magnetic Stimulation Treatment of Depression Using Medical Imaging

Start date: March 1, 2018
Phase: Phase 1
Study type: Interventional

Depression is the most common psychiatric condition and a important public health concern in society. But medications for depression don't work as well as people expected and cause serious side-effects. Transcranial magnetic stimulation (TMS) is a noninvasive electrical stimulation treatment for depression, which has been approved by the FDA and added to the Guidelines for the Treatment of Depression in China. Despite the effect of the treatment is clear ,the TMS target,the neural circuit which plays a role in TMS and its mechanism remain unknown now. TBS target and effective site may be not in the same position. A large number of previous studies demonstrate the advantages and application prospects of different techniques of magnetic resonance (MR)in the study of pathogenesis of depression. Based on the results of previous research supported by the National Natural Science Foundation of China,the National Key Technology Research and Development Program of China during the "10th Five-Year Plan" and New Health Care and New technology. project team puts forward the idea of joint use of brain structure imaging of MR ,Diffusion Tensor Imaging (DTI) and resting-state functional MRI (fMRI) with different analysis methods to conduct a comprehensive study. The study is focused on the effects of TBS treatment on brain structure network, fiber connectivity network and functional connectivity network ,and nodes affected by it. Then we make further investigation about the mechanism of TMS treatment. The research will provide not only help for studying the pathogenesis of depression but also more reliable targets of next TMS treatment.

NCT ID: NCT03492203 Recruiting - Major Depression Clinical Trials

Remote Cognitive Remediation for Depression

RECORD
Start date: December 2016
Phase: N/A
Study type: Interventional

Major depressive disorder is the number one cause of disability worldwide. Evidence regarding the effectiveness of various treatments for patients with severe depression is still lacking. Although many patients achieve treatment response, only a minority of patients achieve full remission and even fewer sustain it. In fact, within one month 10% will be re-hospitalized and the rate climbs to 30% within a year. Further, remission from depressive symptoms is a surprisingly poor predictor of recovery of community functioning following discharge. It is clear that the traditional focus on diagnostic symptoms is insufficient for promoting a full return to everyday functioning. The present aim is to examine the efficacy and effectiveness of treating neurocognition, a symptom that explains persistent deficits in community functioning for those with depression. The study design that maps on to the contemporary clinical setting, in order to reflect the changing landscape of inpatient and community treatment.

NCT ID: NCT03491696 Recruiting - Depressive Disorder Clinical Trials

Effects of the Addition of Metyrapone to Antidepressant Therapy in Depression With Dexamethasone Suppression Test Non-suppression.

Start date: December 22, 2018
Phase: Phase 4
Study type: Interventional

The hypothesis of a link between depression and Hypothalamic-Pituitary Axis (HPA) dysfunction is now experienced. Since a first description in 1949 this link has made the HPA one of the most investigated hormonal axis in depression. Many studies have demonstrated quantitative variations of circulating cortisol in situation of depression including increasing of basal concentration of blood cortisol or Adrenocorticotropic Hormone (ACTH). Furthermore there is an attenuated negative feedback performance of the blood cortisol on the release of ACTH and cortisol. This attenuation seems to be a consequence of a bluntness of sensibility of the hypothalamic cells and their Glucocorticoids Receptors type 2. Actually it seems that these phenomena are included in a diversion of the cortisol's action. From a function of acute stress management, with short-time exposures, the cortisol become one of the factors increasing an allostatic load, or resulting of this increase, maintaining a permanent state of stress, an inertia delay to adaptation and facilitating the emergence of psychiatric disorders. This lack of function can be estimated by the Dexamethasone Suppression Test (DST) which, by stimulation attempting of feedback mechanisms by Dexamethasone (which has cortisol-like properties), can show a non-suppressor population with HPA bluntness. If this biological feature isn't a biological marker of depression, because of a lack of specificity and sensibility, is notably associated with a poor outcome and higher risks of suicidal behaviors and pharmacological resistance. Many studies have explored possibilities of action on the HPA to treat depression or improve antidepressant specific therapeutics, with inconstant results. One of the most promising molecule seems to be Metyrapone, a reversible inhibitor of the 11ß-hydroxylase enzyme which transform desoxycorticosterone and 11deoxycortisol to respectively corticosterone and cortisol. There have been several open label studies which aim to explore the possibility of an effect of the combination between Metyrapone and antidepressant molecules. This led to two randomized double blind controlled versus placebo studies whose conclusions are divergent. These conclusions and their heterogeneity lead to think that there is a sub-population which could be better responder to this type of association. Physiopathological knowledges and preliminary observations in DST non-suppressor population by using anti-glucocorticoids therapies , makes it possible to consider possible that responsive sub-population can be defined by the feature " DST non-suppressor ".

NCT ID: NCT03473704 Recruiting - Depression Clinical Trials

Telematic Program for the Treatment of Depression in Type 1 Diabetes

Start date: January 19, 2017
Phase: N/A
Study type: Interventional

In diabetes, web programs have been designed that have integrated cognitive-behavioral therapy (CBT) with diabetes education, obtaining positive results in the mood of the patient. In Spain, no similar approach has been performed in people with diabetes and depression. However, the need to provide professionals with adequate tools to help people with this problem is justified. The main objective of this project is to apply a telematic program for the treatment of specific depression for people with type 1 diabetes designed by our research team in a sample of patients with type 1 diabetes and mild-moderate depressive symptomatology of the province of Malaga. To do this, the sample will be divided into two groups: treatment group (TG) and control group (CG). The design of the study is quasi-experimental, longitudinal randomized pre-post with control group. The treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions, while the control group (CG) will be evaluated in the same phases as the TG. For ethical reasons, the CG will receive the web treatment once the TG intervention has been completed. There will be a follow-up at 3, 6 and 12 months.

NCT ID: NCT03458143 Recruiting - Clinical trials for Ventilatory Depression

Respiratory Depression During an Analgosedation Combining Remifentanil and Ketamine in TCI for Oocyte Retrieval

Start date: February 12, 2018
Phase: N/A
Study type: Observational

This study evaluates the effect of the addition of ketamine to a conscious sedation protocol including remifentanil during oocyte retrieval. The investigators will have 2 groups with different target effect site concentrations, namely 150 ng/ml and 200 ng/ml.