View clinical trials related to Depressive Disorder.
Filter by:This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. In this double-blind randomized placebo-controlled trial, 75 individuals with a Patient Health Questionnaire (PHQ-9) scale score ≥ 10 (MDD) will be enrolled to participate in an 8-week treatment study to obtain 60 completers. Participants will be randomized with a 1-1 ratio to receive the keto-like supplement (n= 30 completers) or placebo (n=30 completers) taken orally three times per day for 8 weeks. Participants will undergo a 10.5-hour screening/baseline evaluation visit split over 2 days at week 0 including questionnaires, neuroimaging before and after supplement or placebo administration and blood draws, office visits at week 2 (1.5 hours), week 4 (3 hours), week 6 (0.5 hours), week 8 (6 hours), a follow-up visit at week 10 (1.5 hours) and two phone calls between visits (weeks 1 and 3) during which a brief clinical assessment will be obtained (10 minutes each). The total time involved in the study is approximately 23.5 hours.
The purpose of this study is to evaluate the Effectiveness and Safety of JS1-1-01 in Patients With Moderate to Severe Depression
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 is a Phase 2B clinical study evaluating the effectiveness and safety of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.
The purpose of this study is to decode different thinking states from the brain activation patterns and identify the neural circuits that disengage from these thinking patterns using functional magnetic resonance imaging (fMRI) measurement in individuals with major depressive disorder.
In certain low- and middle- income country settings, there is a disproportionate level of untreated postpartum depression that presents both acute and long-term risks to a mother's well-being. Although there is increasing willingness among health systems to involve non-specialists, such as community health workers, in the delivery of psychosocial interventions for postpartum depression, the effectiveness of these interventions has been mixed. The incorporation of digital technology, though, has the potential to improve the effectiveness of non-specialist-delivered interventions. The goal of this clinical trial is to evaluate the acceptability and clinical efficacy of the StandStrong intervention- a non-specialist, passive sensing technology-informed (i.e., digital) mental health intervention- as compared to a standard non-specialist mental health intervention among postpartum-depressed mothers in Nepal. Successful completion of the trial will contribute to the optimization of psychosocial intervention delivery for the postpartum context in low- and middle-income country settings.
The peripartum period is the period between the last month of pregnancy and up to a year after childbirth. It can be considered a difficult time for women, as it is a period of transition during which vulnerability to psychiatric disorders and in particular to major depressive disorder (MDD) (Vesga-Lopez, Blanco, Olfson, Grant & Hasin, 2008). Depression with peripartum onset (PPD) is characterised by the fact that the onset of symptoms may occur during pregnancy or within four weeks of delivery, but may also persist for up to 12 months after delivery (American Psychiatric Association, 2013). PPD affects 10 to 20% of women who have given birth (Tebeka et al. 2021). In addition, the psychological distress experienced by the mother during the peripartum period can disrupt interactions with her newborn (Lefkovics et al. 2014). Depression during this period can therefore have long-term consequences, not only for the women who suffer it, but also for their children (Gavin et al. 2005). The investigators now know that women with PPD have deficits in metacognition. Metacognition is the body of knowledge, processes and practices that enable individuals to control and evaluate their own cognitive activities, thereby enabling them to regulate them (Flavell, 1976). Patients with PPD therefore have difficulty identifying, controlling and evaluating their own cognitive activities. These deficits may also represent a risk factor for the development of PPD if they are present at an early stage (Diop et al. 2022). In patients with PPD, metacognitive therapies appear to be effective in reducing symptoms. In 2013, Bevan, Wittkowski and Wells conducted a pilot study to test the effects associated with metacognitive therapy in depression. This was the first published study to evaluate the effects of metacognitive therapy on patients with depression in the peripartum period. It shows promising results which it would be interesting to replicate, as this is a pilot study. A metacognitive training program for depression (D-MCT) was developed by Jelinek, Hauschildt, Moritz and Dubreucq in 2016, it is a brief group intervention that is easy to manage to participants. To date, no study has yet tested this specific program in patients with PPD, but it has been able to show its effectiveness in reducing the metacognitive deficits. In the light of the scientific literature, the aims of this study are, firstly, to demonstrate the efficacy of D-MCT therapy in subjects with post-partum depression. Secondly, to examine the effects of this therapy on mother-child interactions. The investigators make the following assumptions: - Women in the experimental group showed a greater reduction in depressive symptoms and an improvement in metacognitive functioning than those in the control group. - Women in the experimental group showed a reduction in depressive symptoms after therapy (v2) and maintenance of this improvement (v3). - Improvement in the quality of mother-child bonding for women who took part in the program compared with those in the control group. - Improvement in the quality of mother-child bonding after the program (v2 and v3) for women in the experimental group compared with when they entered the program.
This study is a pilot open label crossover trial to assess the feasibility and acceptability of reducing ultra- processed foods (UPF) in a personalized manner from the diets of patients with major depressive disorder who eat a large percentage of UPF.
A feasibility pilot trial that aims to evaluate the acceptability and feasibility of mentalization-based treatment for adolescents (MBT-A) adapted for early adolescents diagnosed with depression.
A randomized controlled study will be conducted to evaluate the impact of nursing intervention based on Meleis' Transition Theory on postpartum depression, maternal self-efficacy, and breastfeeding self-efficacy in women who have experienced preterm birth. The postpartum period represents a transitional and adaptive phase for mothers as they embrace a new role. However, the occurrence of preterm birth and the necessity of neonatal intensive care unit (NICU) care for the newborn can initiate emotional distress in mothers, particularly when facing the admission of their infants to the intensive care setting. Consequently, the transition to new roles for mothers becomes challenging. A healthy transition to the maternal role is crucial for mothers who have experienced preterm birth, positively influencing maternal self-efficacy and breastfeeding practices while reducing the likelihood of postpartum depression. Therefore, the transition to motherhood in women with preterm births is of paramount importance for both the mother and the premature infant, warranting careful consideration and discussion. Women who have experienced preterm birth will constitute the population of the study. During the research period, women who have experienced preterm birth and whose infants are admitted to the neonatal intensive care unit (NICU) will form the population of the study, and the sample will consist of women who consent to participate in the study during the study period. The sample size was estimated using power analysis (G Power 3.1.9.4.) program with a power of (1-β=0.90) and a significance level of (α=0.05), taking into account the mean and standard deviation of a similar study in the literature (Kadiroğlu and Güdücü Tüfekci 2022) (63.53±8.67 for the experimental group; 56.63±9.73 for the control group). The sample size of the study was calculated to be sufficient with a total of 64 women, with 32 women in each group. Considering potential losses during the study process, and in order not to compromise the statistical power of the research, an additional 20% of women were included in the study, resulting in a total of 76 women to be included in the study. Within the scope of the research, data will be obtained through the 'Personal Data Form' containing information about the socio-demographic characteristics of the participating women, as well as the 'Edinburgh Postnatal Depression Scale,' 'Perceived Maternal Self-Efficacy Scale,' and the 'Breastfeeding Self-Efficacy Scale.