View clinical trials related to Major Depressive Disorder.
Filter by:This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an adjunctive treatment of Major Depressive Disorder. Study participants will continue to take their current antidepressant therapy in addition to the study drug or placebo for the duration of the treatment period.
Perinatal depression affects 10-15% of women postpartum and has a recurrence rate of 40%. Women who develop perinatal depression might be particularly susceptible to the rapid and large changes in sex steroid hormones, particularly estradiol, across pregnancy to postpartum. This trial aims 1) to evaluate the preventive effect of transdermal estradiol treatment in the immediate postpartum on depressive episodes in a subgroup of women at high-risk for perinatal depression, and 2) to determine if a set of biomarker gene transcripts can identify this subgroup and thus form the basis for future personalised prevention or treatment. The MAMA Trial is a double-blind, 1:1 randomised, placebo-controlled trial. The trial involves maternity wards at three university hospitals in the Capital Region of Denmark. Women who are singleton pregnant in the third trimester with a prior history of perinatal depression are eligible to participate. Participants will be randomised to either estradiol patches (200 μg per day) or placebo patches for three weeks starting immediately postpartum. The primary statistical analysis will be performed based on the intention-to-treat principle. A sample size of 220 will provide the trial with 80% power (alpha 0.05, beta 0.2) to detect a reduction in postpartum depression of 50% and to tolerate a drop-out of around 20%.
The safety and effectiveness of the BrainsWay deep transcranial magnetic stimulation (DTMS) device for the intended use of Major Depressive Disorder (MDD) using the intermittent theta-burst (iTBS) stimulation protocol will be evaluated in a non-inferiority study, comparing the iTBS treatment with the FDA cleared, (510(k) No. K122288) Brainsway DTMS device to the High Frequency (HF) protocol using the same device.
The R61 will be an open trial to determine if Positive Processes and Transition to Health (PATH) engages the proposed targets: unproductive processing, avoidance, and reward deficits in a sample of 45 adults who have experienced a destabilizing life event involving profound loss or threat, report persistent stressor-related symptoms of PTSD and/or depression, and are elevated on symptoms related to 2 of the 3 therapeutic targets. Additionally, will examine whether patients perceive PATH as helpful and complete/adhere to treatment, and therapist fidelity. Patients will receive 6 sessions of PATH (with 2 boosters, if partial responders). Primary targets will be assessed at pre-treatment, week 4, post-treatment, and at 1- and 3-month follow-up; secondary targets at pre-treatment, weekly during treatment, post-treatment, and at 1- and 3-month follow-ups.
SPL026 (N,N-dimethyltryptamine [DMT] fumarate) is a psychedelic tryptamine being developed as a therapy for patients with major depressive disorder (MDD).
The Electro-Convulsion-Therapy (ECT) is a well accepted treatment option in severe depression. The quality of ECT is evaluated basing on minimal seizure duration (>15sec), the sympathic response and the postictal EEG-suppression. - Page 1 of 3 - For the treatment general anaesthesia is needed. On the other hand anaesthesia strongly influences the quality of the seizure. Standard treatment is to use Anaesthesia to intervention time (ASTI) of 1 to 2 minutes for ideal timing of the electric stimulation. The aim of the study is to assess if timing of electric stimulation aiming for ar an anaesthesia depth of Narcotrend values 41-64 may provide better convulsion quality than standard approach of using ASTI 1-2 minutes.
The objective of this post marketing surveillance is to further gather local data on the safety and efficacy of Brexpiprazole (RexultiTM) Film-coated Tablet in the treatment of schizophrenia and adjunctive therapy of Major Depressive Disorder.
Background: In 2012, over 3.2 million Canadians over 15 (11.3%) years reported symptoms of major depressive disorder (MDD), and barriers such as lack of readily available care system, stigma and affordability of health care services were reported by millions of Canadians who expressed they had unmet or partially met mental health care needs. There is the need to develop innovative psychological interventions which are not human resource intensive, are easily accessible, cost-effective, are geographic location independent, scalable, and can be offered to thousands of people simultaneously. Supportive text messaging has been proven in clinical trials to be effective in alleviating depression symptoms but are limited in their ability support those without active cell phones. Objective: The objective of this study is to evaluate the feasibility, comparative effectiveness and user satisfaction with daily supportive e-mail messaging as an intervention to treat patients with MDD when compared to daily supportive text messaging. Method: In this innovative two-arm randomized non-inferiority pilot trial, patients with MDD receiving usual care would be randomized to receive either daily supportive email messaging or daily supportive text messaging of the same content for six months. The Patient Health Questionnaire (PHQ)-9 scale will be utilized to record depression symptom scores, the Generalized Anxiety Disorder (GAD)-7 scale would be used to record the anxiety symptoms and quality of life will be measured using the WHO (Five) Well-Being Index (WHO-5) at baseline, 6, 12 and 24 weeks. Primary outcomes would be the mean difference in change scores on the PHQ-9 and WHO-5 scales from baseline to 6, 12 and 24 weeks for the two study arms. Secondary outcomes include changed scores on the GAD7 scale from baseline to 6, 12 and 24 weeks for the two study arms, the dropout rates and the satisfaction rates at 12 and 24 weeks for participants in the two treatment arms. All outcome measures would be analyzed using descriptive and inferential statistics. Qualitative data will be analyzed using thematic analysis aided by NVIVO software. Results: We expect the study results to be available within 18 months of study commencement. Conclusion: The results of this study will shed light on the feasibility, acceptability and effectiveness of using automated email supportive message interventions in the management of patients with MDD.
Most of the current antidepressants for major depressive disorder (MDD) are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. NMDA hypofunction has been implicated in the pathophysiology of depression. Therefore, this study will examine the efficacy and safety as well as cognitive function improvement of an NMDA enhancer (NMDAE) in the treatment of MDD in the adults.
This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with treatment resistant depression (TRD) and major depressive disorder (MDD).