Active clinical trials for "Depressive Disorder"

Open label placebo treatment has been tried for irritable bowel syndrome (Kaptchuk et al, 2010), where three weeks of open label placebo proved superior to a wait-listed control group. Another pilot study demonstrated efficacy in treating children suffering from ADHD with open label placebo treatment (Sandler & Bodfish, 2007). Recent work has shown that placebo openly given can have significant analgesic effects for acute migraines (Kam-Hansen et al, 2014) and for experimentally-induced pain (Schafer at al, 2015). A preliminary attempt to treat depression with open label placebo proved the feasibility of such a study, but was too small and brief for conclusive results (Kelley et al, 2012). We provide here the protocol for a study to assess the effect of open label placebo treatment for depression.

Major depressive disorder (MDD) characterized by high prevalence, high recurrence rate and high disability rate is a mental illness with the heaviest burden and has become a major public health issue in China and the world. Great challenges in diagnosis and treatment of depression consist of the complicated pathogenesis, a lack of objective diagnostic criteria, unsatisfactory treatment outcomes and poor treatment compliance. The previous studies of our research team showed that depression is affected by multiple factors. We could explore important markers for the diagnosis, treatment and prediction of treatment efficacy in depressed patients' data collected from different dimensions including immunometabolism, brain electrophysiology, brain structure and functional neural circuits, neuropsychology and psychophysiology. Our completed studies in the National Science and Technology Support Program and National Key Research and Development (R&D) Program of the 12th and 13th Five-Year Plan in China found that treatment designed for specific clinical subtypes can improve the treatment effect, and meanwhile, the application of electronic-measurement based care (e-MBC) combined with smart mobile terminals can effectively provide whole-course medical management for patients, improve patient compliance and increase the efficacy of clinical diagnosis and treatment. However, due to disease diagnosis based on clinical symptomatology without subtype distinction and lack of multi-scale biological data mining, multidimensional assessment and deep integration, the results of most previous studies can hardly be used in clinical practice. Therefore, there is a strong urge to carry out a systematic research in which multidimensional evaluation of clinical characteristics and a large scale of data collection and mining are needed to form clinical diagnosis and optimal treatment regimens for depression subtypes. To achieve the goal, patients with depression will be our research subject in this study. First, on the basis of the previous cohort study and the whole-course e-MBC, patients' data of movement, respiratory rate, heart rate and sleep will be further collected. With the help of artificial intelligence (AI) technology such as deep machine learning, the data integrated with EEG imaging and specific immunometabolic markers in blood will be analyzed with clinical characteristics. The model of diagnosis and classification will be established based on multidimensional clinical assessment and verified. Second, through a prospective multicenter randomized controlled trial, optimal treatment regimens for different depression subtypes and individualized magnetic stimulation physical intervention technology navigated by AI will be explored so as to establish a predictive model of curative effect. Finally, long-term follow-up and its regular data collection can be completed on the patient diagnosis and treatment platform which is linked to the e-MBC. Thus, a stable clinical cohort and an advanced database containing multidimensional information of depression will be set up. The whole course e-MBC management platform will be optimized and promoted to improve patient compliance, treatment efficiency and prognosis. This study can provide evidence for precise diagnosis and classification of depression and optimal treatment regimens for different subtypes.

To compare the efficacy of blue light, bright light and dim light in the treatment of with nonseasonal major depression disorder(MDD) in adults.

Internet-Based Interventions are increasingly relevant as an alternative for reducing the gap in treatment of metal disorders such as depression, especially in resource-limited regions. In this study the investigators will try to evaluate the effectiveness of an Internet-Based Intervention culturally adapted to the Ecuadorian population for treatment of depression.

Postnatal psychopathology have adverse impact on both mothers and infants. Few postnatal women with depressive symptoms receive treatment, and pharmacological intervention has not been well accepted due to the medication side-effects. Recently, mindfulness-based interventions were found to be beneficial for symptoms in perinatal and antenatal women with depression. These non-pharmacological interventions require less resources and are more feasible for postnatal women to practice at home. To date, no randomized controlled trial has examined mindfulness-based intervention program as a treatment for women with postnatal depression. The proposed randomized controlled trial aims to examine the effects of an 8-week mindfulness-based intervention program on symptom and cognition for postnatal females with depressive symptoms. A total of 70 postnatal women with depressive symptoms will be recruited from the psychiatric outpatient clinics in Hong Kong, and will be randomized into two groups: 1) an 8-week mindfulness-based intervention program (n=35); 2) a booklet-based psychoeducation control group (n=35). All participants will be assessed for depression, anxiety, stress, cognition, role functioning, quality of life, sleep quality and mindfulness ability at the baseline, 8 weeks, and 3 months after intervention. The intervention sessions will be held once weekly lasting 90 minutes for 8 weeks. The investigators primarily hypothesize that participants in the mindfulness-based intervention group will improve depressive symptom after 8 weeks compared with the control group. Secondary, the mindfulness-based intervention will improve anxiety, stress, cognitive functions, sleep quality, quality of life and mindfulness ability.

The purpose of this study was to evaluate the efficacy and safety of agomelatine augmentation antidepressant therapy in patients with major depressive disorder with inadequate response during early stage of treatment.

The TARGET study is an active-controlled evaluation of AXS-05 compared to bupropion in patients with treatment-resistant major depressive disorder (MDD) who are adherent to study drug. Subjects are considered to have treatment-resistant MDD if they have had a historical inadequate response to 1 or 2 prior antidepressant treatments (ADTs) and a prospective inadequate response to treatment with bupropion SR, during the current major depressive episode. The TARGET study will first determine treatment adherence based on analysis of drug concentrations of dextromethorphan (in the AXS-05 group) and bupropion (in the bupropion group), and then evaluate the efficacy of AXS-05 in patients determined to be treatment-adherent. Efficacy data for evaluation of treatment effect will be obtained from assessments made during study AXS-05-301.

This study intends to carry out a prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subanesthetic sevoflurane for treatment-resistant depression.

Bipolar disorder, a type of mood disorder that occurs in various forms, such as depression, mania, hypomania or irregularity.According to the World Health Organization mental health survey, the lifetime prevalence of bipolar disorder is 2.4%; the 12-month prevalence was 1.5%. The lifetime incidence in Shenzhen was 1.5%, and the 12-month incidence was 1.1%. In another study in Hong Kong, the 12-month prevalence of bipolar I, II, and "soft" II was 1.4%, 0.5%, and 1.8%, respectively. Due to endocrine effects, bipolar disorder is more common in women than men, and mainly occurs in late adolescence and early adulthood, with an early trend. An investigation involving 23 countries around the world found that the average age of onset of bipolar disorder was 25 years old, and the low age group (17.24±3.20 years old) accounted for 41.7%. Another study in the United States showed that the average age of onset of bipolar disorder was 20 years old, and the low age group (14.5±4.9 years old) accounted for 63%. With the improvement of medical level, the diagnosis rate of bipolar disorder is getting closer to the true prevalence rate. Without active treatment, the symptoms of bipolar disorder, especially depression, will accompany the patients for a long time. The quality of life of patients is seriously affected. The safety of piperopilon hydrochloride has been widely recognized from pre-market clinical research to post-market clinical practice. A total of a clinical study involving 1191 patients showed that the incidence of side effects from long-term use of piperopilone was 21.3%, and the main side effects were mild in the nervous and digestive systems. In addition, it has been reported that piperopirone is also safe and effective for adolescents.Therefore, the investigators designed this study to explore the atypical antipsychotic drug piperopirone as a monotherapy or in combination with mood stabilizer.Clinical efficacy and safety of lithium acid in the treatment of depressive episodes in adolescents with bipolar disorder, and its improvement in cognitive function were assessed.The goal is to evaluate the efficacy and safety of piperopilone hydrochloride tablets in the treatment of bipolar depressive episode in adolescents.

This study will be a randomized controlled trial on the effects of group-based LM as an intervention for depression. Prior to all study procedures, an online informed consent (with phone support) will be obtained from potential participants. Around 90 eligible participants will be randomly assigned to either the LM intervention with self-tracking tools (LM/S), pure LM intervention (LM), or care-as-usual (CAU) control group in a ratio of 1:1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. In order to obtain unbiased data with respect to the participants' attitudes and behaviors, incomplete disclosure will be used to withhold the self-tracking component in this trial. Participants in the two LM groups will receive six weekly group lifestyle modification sessions (~2 hours each) at the Chinese University of Hong Kong (an online approach will be adopted if face-to-face sessions are not possible due to COVID-19). The group treatment will primarily be delivered by clinical psychology trainees under the supervision of a clinical psychologist and other healthcare professionals such as a dietitian and a fitness trainer. The CAU group will continue receiving the routine care as usual and be given a smartphone-based LM intervention after the completion of follow-up assessments. Both the treatment groups and control group will complete a set of online questionnaires before the treatment commences, immediately after treatment, and 12 weeks after the treatment sessions are completed. In addition, participants in the LM/S group will complete a set of self-developed survey questions related to lifestyle and mood on a daily basis.