View clinical trials related to Depressive Disorder, Major.
Filter by:The study's primary objective is to evaluate the effectiveness of Tinazidine compared to Zolpidem in enhancing sleep quality, with secondary objectives including the assessment of adverse effects, safety profile, and patient tolerance with each treatment. The trial will be conducted as a double-blind RCT, with participants randomly assigned to receive either Tinazidine (0.1 mg/Kg/HS) or Zolpidem 10 mg HS, for 12 weeks. Eligible participants, aged 18-60 years, diagnosed with primary insomnia as per DSM-5 criteria, will be recruited from an outpatient sleep clinic affiliated with Al-Masara Hospital. Data on sleep quality, and side effects, will be collected using the Sleep Pittsburgh Sleep Quality Index (PSQI), Clinical Global Impression (CGI), sleep diaries, actigraphy, polysomnography, and regular clinical interview though OPD follow-up visits. The primary outcome considered was the mean global PSQI score before and after the treatment. The primary outcome will be measured four times (baseline, 4 weeks, 8 weeks, and 12 weeks), We considered an attrition rate (dropout/lost follow-up) of 10%. Therefore, the sample size is 90 subjects (45 in each group). Group comparisons for mean scores will be conducted using independent samples t-tests, and within-group comparisons will be assessed using paired samples t-tests. Changes in sleep quality over time between treatment groups will be evaluated using repeated measures ANOVA. Associations between categorical variables will be examined using Chi-square tests (including Fisher's exact or Likelihood ratio tests as appropriate). Statistical significance will be considered for p-values less than 0.05. All analyses will be performed using IBM SPSS Statistics (Version 29.0). The findings of this study seek to elucidate the comparative efficacy and safety profiles of Tizanidine and Zolpidem in treating primary insomnia. The study aims to offer insights into the effectiveness of Tizanidine versus Zolpidem in improving sleep quality among patients with primary insomnia. Through the evaluation of efficacy, adverse effects, and safety profiles. This study aims to inform clinicians and healthcare practitioners about the optimal treatment choices for individuals with primary insomnia.
The goal of this clinical trial is to test a new brain stimulation treatment target for individuals with depression plus at least one additional psychiatric disorder. The main question is to understand the safety profile of a non-invasive form of brain stimulation called accelerated intermittent theta burst stimulation when it is targeting the posterior parietal cortex. Additional questions focus on whether this stimulation improves symptoms of depression and other psychiatric disorders as well as whether this stimulation changes brain function.
The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of major depression disorder compared to venlafaxine hydrochloride sustained-release tablets, to provide evidence-based basis for clinical rational drug use.
The purpose of this study is to use transcranial magnetic stimulation (TMS) to better understand the neural circuits associated with social motivation. Participant includes four study visits each that range from 1.5 - 3.0 hours in duration over approximately a one month period. The first study visit involves answering survey questions, a clinical interview, and computer tasks. The second study visit involves a magnetic resonance imaging (MRI) scan, computer tasks, and a brief TMS protocol. The second and third study visits involve a full session of TMS followed by an MRI scan and computer tasks. Adults in the Auburn/Apelika area who avoid social situations, experience symptoms of depression or social anxiety, and are between 25 years old and 50 years old are eligible to participate.
The purpose of this study is to investigate the responses of the brain region known as the subgenual anterior cingulate cortex (sgACC) during transcranial magnetic stimulation (TMS) in individuals with depression. Specifically, investigators aim to determine whether the sgACC is engaged when TMS is delivered to specific targets and if the engagement of sgACC changes throughout a full TMS treatment intervention. To achieve this goal, the investigators will employ a combination of TMS and Magnetic Resonance Imaging (MRI) procedures. Study participation will include completing various questionnaires, clinical assessments, receiving a full transcranial magnetic stimulation (TMS) treatment intervention (every weekday for 4-6 weeks), and undergoing MRI scans, both with and without concurrent TMS.
To explore the effectiveness and safety of rTMS intervention with different targets in the left prefrontal cortex defined using the pBFS method, in adult patients with moderate and severe depressive disorder. Second, investigate the neural circuit that responds to the rTMS intervention using individualized brain image analysis, which may help to establish an effective target for the neuromodulation of patients with major depressive disorder.
This open-label functional Magnetic Resonance Imaging (fMRI) study will assess the effects of a single dose of psilocybin on rumination and the neural correlates of rumination in individuals with major depressive disorder.
The effectiveness of psychomotor therapy in improving clinical outcomes or quality of life for individuals with depression is unclear. The investigators will assess how the participants' quality of life and psychomotor profile change over time. The study aims to compare the quality of life at 3 months between patients who received 3 months of personalised psychomotor therapy in addition to standard treatment and those who received standard treatment alone. The study lasted for 6 months, and the investigators expects a total of 128 people to participate in this research across several hospital establishments. This study evaluates the effectiveness of two types of treatment, divided into two randomly selected groups. To participate, individuals must have a medical diagnosis of major depressive disorder (MDD) and be between the ages of 20 and 60. They must have depressive symptoms with an HDRS score greater than 16 and provide informed consent. They must be treated or hospitalised at the Centre Hospitalier Esquirol or the Centre Hospitalier Henri Laborit (France). After providing consent, they will undergo an initial clinical interview that evaluates anxiety, self-esteem, pleasure, and quality of life. The therapist assessed the participant's muscle tone, gross motor skills, praxis, manual dexterity, rhythm, processing of sensory information, and body image. Following the assessment, the participant was randomly assigned to either the experimental or control group. The experimental group received the usual treatment for depression and underwent psychomotor therapy once a week for 12 weeks. The control group received the standard treatment for depression and underwent weekly telephone interviews. An assessment is scheduled at 1 month to evaluate the participant's health status, including any changes to treatment and assessment of anxiety and depressive symptoms. Another interim check-up is scheduled at 3 months to assess the patient's health status. The interview will also assess any changes to treatment, anxiety and depressive symptoms, quality of life, and psychomotor function. A final visit will be scheduled at 6 months for an assessment of the participant's health. The interview will also assess any changes to treatment, anxiety and depressive symptoms, quality of life, and psychomotor function.
The purpose of this study is to evaluate the efficacy of psilocybin on the symptom of anhedonia in individuals with treatment-resistant major depressive disorder.
The aim of this clinical trial is to evaluate the effects of a Resilience and Stress Management Intervention Program (RASMUS) compared with yoga on stress perception, coping strategies, depressive symptoms, anxiety, resilience and quality of life in people diagnosed with major depressive disorder (MDD) in the short and long term. In addition to psychological factors, biological parameters will be examined to define biomarkers involved in stress response. In the optional neuroimaging part, the effects of the planned interventions on the structure, metabolism and function of the brain will be investigated. The epigenetic part, which is also optional, will examine the effects of the planned interventions on the histone modifications.