View clinical trials related to Major Depressive Episode.
Filter by:The primary aim of this project is to test if OCOsense glasses can function as a digital phenotyping tool derived from behavioural and physiological signals related to facial expression and motion recorded using the glasses.
Background: Major changes in female sex hormone concentrations influence the development of depressive symptoms in women. This hypothesis has been thoroughly investigated with regard to the menopause, the postpartal phase and also premenstrual dysphoric disorder. However, much less is known regarding the impact of female sex hormone fluctuations on depression during the regular menstrual cycle. There are indications that during the luteal phase, women might be more vulnerable to the development of depressive symptoms, while during the follicular phase and at ovulation, hormone concentrations might present a protective factor against depressive symptomatology. Subjective stress could mediate the relationship between depressive symptom development and the menstrual cycle phases. The complex interaction between sex hormones and psychological symptoms in the course of menstrual cycle phases is still understudied. Method: 74 women (37 with and 37 without current depressive episode), will take part in a smartphone-based ambulatory assessment. Women will provide daily ratings of depressive symptoms and perceived stress for a period of one menstrual cycle (approx. 26-30 days). Three menstrual cycle phases will be assessed - the follicular phase, ovulation and the luteal phase. An ambulatory assessment will be used for these daily assessments. To assess the menstrual cycle phase participants will use ovulation tests on five days in the late follicular phase. The following research questions will be investigated: Research question 1: Do depressive symptoms (number and severity) change in the course of the menstrual cycle within the two groups? Research question 2: Which depressive symptoms are particularly sensitive to changes in the course of the menstrual cycle phases? Research question 3: Does the subjective stress change in the course of the menstrual cycle within the two groups? Research question 4: Are there differences between depressive and healthy women in terms of changes in depressive symptoms and subjective stress experience? Implications: The aim of the study is to investigate women-specific psychobiological factors influencing depression. Therefore, fluctuations in depressive symptoms and subjective stress experience will be investigated as a function of the respective menstrual cycle phases. The identification of cycle phases associated with increased or reduced vulnerability to depressive symptoms will support the development of women-specific prevention and treatment programs.
Objectives The primary objective of this study is to determine the convergent validity of the mobile DSST application with the pencil and paper version of the DSST. Design and Outcomes This study will be performed by the Brain and Cognition Discovery Foundation (BCDF). The BCDF is an organization based in Toronto, Ontario, Canada led by Dr. Roger S. McIntyre. Membership of the BCDF has developed and validated rating scales and metrics for adults with mood disorders for over 10 years. A member of the BCDF provides diagnoses and treatment for adults (age 18-65) with mood disorders and provides clinical care to the largest catchment area in Canada. The BCDF conducts clinical research according to the International Conference on Harmonization, Declaration of Helsinki, and Good Clinical Practice (GCP) guidelines. The study will be approved by the community Research Ethics Board. Thirty adults (18-65) with DSM-5 MDD will be enrolled at the BCDF Toronto, Ontario. All subjects will have their diagnosis ascertained clinically and confirmed by Mini International Neuropsychiatric Interview Version 5.0 (M.I.N.I.). At baseline, data will be collected from all participants and will include demographics, comorbidities, medication history and concurrent medications. All subjects will be assessed symptomatically with the Montgomery and Asberg Depression Rating Scale (MADRS) as well as the Hamilton Anxiety Rating Scale (HAM-A), Snaith Hamilton Pleasure Scale (SHAPS) for anhedonia, as well as the paper and pencil version of the DSST at baseline and end of study (Day 7). The DSST has been normed on the sex, age and gender. These norms will be used as reference. All subjects will complete the pencil and paper version of the DSST and complete the mobile app-based version of the DSST. Sample Size and Population This is a small validation study of 30 subjects. Subjects diagnosed with major depressive disorder will be eligible for participation in this study.
This trial attempts to explore the treatment outcome of magnetic seizure therapy (MST) for major depressive episode. Half of the participants will receive MST, while the other half will receive electroconvulsive therapy (ECT).
On November 13th 2015, a terrorist attack killed 129 victims in Paris. An emergency crisis unit (CUMP) has been activated in Paris in the days following the attack and a subunit was in charge to answer to the phone calls of victims and their relatives. The same emergency crisis unit have been activated for the terrorist attack in London, 2017 june 3, terrorist attack in Barcelone 2017 august 17-18, terrorist attack in Strasbourg 2018 December 11 The purpose of this observational study is to document the evolution of psychiatric symptoms among subjects who called the CUMP and to collect information about the type of medical or non-medical care they were seeking for.
Dysregulation of the hypothalamus-pituitary-adrenal (HPA) axis as well as maladaptive activation of the autonomic nervous system (ANS) are discussed as relevant factors in the development of a major depressive episode and as a correlate of its clinical manifestation. Preliminary evidence suggests that the hypercortisolaemic pattern in a subgroup of depressed patients may predict non-responses to psychotherapeutic treatment. At the same time, it is conceivable that disorder-related alterations in HPA axis and ANS regulation change in response to effective treatment, such as cognitive behavioural therapy (CBT), and that those changes could parallel changes in depressive symptoms. Identifying such associations may shed light on biological and psychological mechanisms of action underlying successful treatment. However, so far, no studies have investigated depressed patients with regard to dysregulation in both stress systems, HPA axis and ANS, before psychotherapeutic treatment, nor have changes in functioning of both systems been inspected in response to treatment. Moreover, a detailed investigation of depressive symptom trajectories over the course of treatment and its associations with changes in HPA axis and ANS regulation is lacking. It can be speculated that specific techniques of the treatment, e.g., typical CBT elements, such as behavioural activation or cognitive restructuring, might particularly be associated with changes in HPA axis and ANS regulation. The main aims of this project are to investigate: 1. whether diurnal salivary cortisol and alpha-amylase as well as hair cortisol concentrations change from pre- to post-intervention in treatment responders compared to non-responders; 2. whether diurnal salivary cortisol and alpha-amylase concentrations change from pre- to mid-intervention and from mid- to post-intervention in treatment responders compared to non-responders; 3. whether changes in diurnal salivary cortisol, alpha-amylase and hair cortisol concentrations are significantly correlated with changes in depressive symptoms; 4. whether concentrations of diurnal salivary cortisol and alpha-amylase as well as hair cortisol at pre-treatment predict future treatment response (i.e., on a psychological level). On an exploratory level, it will be investigated: 5. which elements of a CBT intervention for depression (behavioural activation vs. cognitive restructuring) are associated with changes in diurnal salivary cortisol and alpha-amylase concentrations. It is hypothesised: 1. that pre- to post-intervention decreases in diurnal salivary cortisol and alpha-amylase as well as hair cortisol concentrations will be more pronounced in responders compared to non-responders. 2. that pre- to mid-intervention and mid- to post-intervention decreases in diurnal salivary cortisol and alpha-amylase will be more pronounced in responders compared to non-responders. 3. that changes in depressive symptoms will significantly correlate with changes in diurnal cortisol and diurnal alpha-amylase as well as hair cortisol concentrations. 4. that pre-intervention diurnal salivary cortisol and alpha-amylase as well as hair cortisol concentrations will be higher in future non-responders, compared to responders.
This study addresses the unmet medical problem of insufficient treatment of late life depression (LLD). Compared with depression in early adulthood, treatment options of LLD are limited. This trial is the first confirmatory multicentre study to test the efficacy of an LLD-adapted cognitive behavioural therapy (CBT) program. It will test the hypothesis, that LLD-specific cognitive behavioural therapy (CBT) is superior to unspecific supportive intervention (SUI) with regard to reducing symptoms of depression over the course of 6 months. Secondary goals are to test the efficacy of LLD-CBT in comparison with SUI on patient reported outcome in major depressive disorders (PRO-MDD), anxiety, cognition, quality of life, overall health status, sleep and global clinical impression.
The primary goal of the proposed study is to compare the effectiveness of universal school based screening for adolescent major depressive disorder to the current school process of targeted screening based on concerning behavior.
This is an open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in the treatment of participants with bipolar I/II disorder with a current major depressive episode.
This study will determine whether the Medibio Depression Diagnostic Aid exceeds minimally acceptable thresholds for sensitivity and sensitivity in cases with a current depression episode and non-depressed controls.