View clinical trials related to Unipolar Depression.
Filter by:Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia, daytime sleepiness and fatigue. This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex (DLPFC) and cTBS over the right DLPFC, compared to sham stimulation, in treatment of insomnia, daytime sleepiness and fatigue in depression.
Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression.
This is an open-label study, in which all participants receives an active treatment with repetitive transcranial magnetic stimulation (rTMS) according to clinical protocol. The aim with this pilotstudy is to investigate the feasibility to perform a trial of low-frequency rTMS on treatment-resistant depression in adolescents. The study includes adolescents 13-19 years old, with average to severe depression.
The study aims at investigating if tDCS applied to left DLPFC or to right OFC to treatment as usual is effective in reducing severe suicidal ideas in major depressive episode.
Based on robust evidence from literature, the investigators hypothesize the presence of disease-specific neurobiological underpinnings for bipolar and unipolar disorder, which may serve as biomarkers for differential diagnosis. However, the group comparison approaches adopted in psychiatric research fail to translate the emerging knowledge to the diagnostic routine. How can physicians predict differential diagnosis and treatment response by using cutting-edge knowledge obtained in the last decade? How can such extensive knowledge be useful and applicable in clinical practice? With this project, the investigators propose a solution to these challenges by developing a software tool that integrates the available clinical, biological, genetic and imaging data to predict diagnosis and outcome of new individual patients. The decision support platform will employ artificial intelligence, specifically machine learning techniques, which will be "trained" through data in order to predict the category to which a new observation belongs to. By doing this, existing and newly acquired multimodal datasets of bipolar and unipolar patients will be translated into predictors for personalized patient diagnosis and prognosis. The project can have a great impact on psychiatric community and healthcare system. Identifying predictive biomarkers for UD and BD will provide an essential tool in the early stages of the disease, ensuring accurate diagnosis, enhancing prognosis and limiting health care costs. The investigators will recruit 80 bipolar patients, 80 unipolar patients and 80 healthy controls for the MRI study. Clinical, genetic and inflammation data will be acquired from all subjects. The following data will be obtained: age, gender, number of episodes, recurrence, age of illness onset, lifetime psychosis, BD or UD familiarity, tempted suicide, medication, scores at HDRS, Beck Depression Inventory and BACS battery. MRI will be performed on 3.0 Tesla scanners. MRI acquisitions will include SE EPI DTI, T1-weighted 3D MPRAGE and fMRI sequences during resting state and a face matching paradigm, which previously allowed defining the connectivity in mood disorder. Blood samples samples will be collected and plasma will be extracted and stored at -80. Pro- and anti-inflammatory cytokines will be measured using the Bioplex human cytokines 27-plex. Genetic variants associated considered for differential diagnosis will be evaluated using the Infinium PsychArray-24 BeadChip. This cost-effective, high-density microarray was developed in collaboration with the Psychiatric Genomics Consortium for large-scale genetic studies focused on psychiatric predisposition and risk. The relevance of the single clinical, genetic, molecular and image-based features as bipolar and unipolar disorder signatures will be evaluated by considered the cutting-edge literature and estimated on a independent already existing dataset (30 subjects per group). General Linear Model analyses followed by two sided t-tests will be used to identify whether each parameter significantly differs among groups, while removing the contribution of age, gender, length of illness and other confounding factors. A multiple kernel learning (MKL) algorithm will project the multisource features to a higher-dimensional space where the three subject groups will be maximally separated. The selected features will be used both separately and in combination. The nuisance effects of age, gender, length of illness and MRI system will be corrected during the training phase of the algorithm. The MKL classifier will be tested using a k-fold nested cross-validation strategy with hyperparameter tuning. The training dataset is already made available and includes about 550 subjects. The software architecture will be designed in Matlab environment by integrating quantitative imaging methods, machine learning algorithm and statistical analyses as separate modules in a user-friendly interface, which will facilitate the sharing of computational resources in the clinical community.
Many different forms of depression exist. It is difficult to predict to what treatment a given patient with depression responds. Studies demonstrate that biomarkers can help to distinguish different forms of depression. Simple markers, like aldosterone/cortisol in body fluids, blood pressure and inflammation markers , have been identified as predictors of therapy resistance in depression. Enoxolone is a molecule derived from the licorice plant and has demonstrated an effect on these biomarkers, which may imply an improved response. The current randomized placebo controlled study is assessing whether the presence of markers of therapy resistance can predict a preferential effect of enoxolone vs. placebo on clinical outcome. Secondarily, it is tested whether these markers change differentially in the treatment groups. Finally, the relationship between the change of the markers and clinical change will be assessed.
Depression is a highly disabling disease that is prevalent throughout the world. The treatments proposed and studied to date have shown to be partially effective in treating this condition. Neuromodulation strategies have been used as an alternative, especially for refractory and challenging cases. In this context, studies investigating the effectiveness of transcranial magnetic stimulation, including the theta burst stimulation (TBS) modality, have been increasing in number. However, there is still a lack of information seeking to explore the maximum effectiveness in the TBS modality. Therefore, the investigators developed a new stimulation protocol consisting of 3 TBS sessions per day, with an offer of 1200 pulses per session and a 30-minute interval between sessions. The protocol will be performed for 15 days, totalizing 45 stimulation sessions. The stimulations will be directed to the left dorsolateral prefrontal cortex (F3) and will be performed in a Magventure MagPro R30 device. The investigators will select 100 patients with unipolar major depression, following previously established inclusion and exclusion criteria, and will apply the protocol randomly, dividing the patients into an active and placebo group. The research team hypothesized that the active group patients will have greater improvement in symptoms of depression assessed by the 17-item hamilton depression scale over patients of the placebo group. In addition, other scales will be used for secondary outcomes. The researchers also hypothesized that there will be no difference between patients placed in the active or placebo groups in terms of side effects.
Pragmatic, 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.
First-line treatments for major depressive disorder (MDD), antidepressants and psychotherapy, are associated with refractoriness and discontinuation due to side effects, and logistical burdens, respectively. In this scenario, transcranial electrical stimulation (tES) is nowadays considered effective and safe for MDD, albeit with a modest effect size, and also prone to logistical burdens when performed in external facilities. In this regard, clinical investigation involving portable tES (ptES), and the potentiation of ptES with remotely-delivered psychological interventions, have shown positive, but preliminary, results. Here, the investigators present the design and rationale of a single-center, multi-arm, randomized, double-blind, sham-controlled clinical trial with digital features, using ptES (ptES) and internet-based behavioral therapy (iBT) for MDD (PSYLECT). This study will evaluate the efficacy, safety, tolerability and usability of (1) active ptES + active iBT ("double-active"), (2) active ptES + sham iBT ("ptES-only"), and (3) sham ptES + sham iBT ("double-sham"), in adults with MDD, with a Hamilton Depression Rating Scale - 17 item version (HDRS-17) score ≥ 17 at baseline, during 6 weeks. No antidepressant washouts will be performed during the trial. Three co-primary hypotheses are presented: changes in HDRS-17 will be greater in (1) "double-active" compared to "ptES-only", (2) "double-active" compared to "double-sham", and (3) "ptES-only" compared to "double-sham". The investigators aim to enroll 210 patients (70 per arm). The results of this trial should also offer new insights regarding the feasibility and scalability of combined ptES and iBT for MDD, in the area of digital mental health.
This study will determine the safety and efficacy of home administered tDCS in adults with unipolar depression. The device used to administer tDCS will be the Soterix Medical 1X1 mini-CT. 32 tDCS sessions of 30 minutes each will be delivered over 10 weeks.