Intracalvarial Prefrontal Cortical Stimulation in Treatment-Resistant Depression
Chronic intracalvarial cortical stimulation is a minimally invasive method involving the neurosurgical placement of an electrode above the inner table of the skull. Over time, intracalvarial cortical stimulation is intermittently activated to modulate locally and distally connected brain regions. Because of the important role played by the dorsolateral prefrontal cortex in mood regulation, the goal of this study is to apply intracalvarial prefrontal cortical stimulation (IpCS) over the dorsolateral prefrontal cortex in severely treatment-resistant depressed (TRD) patients. Per the DSM-V and Centre for Medicare and Medicaid Services (CMS) nomenclatures, TRD patients are commonly defined as those whose treatment failed to produce response or remission after 2 or more attempts of sufficient duration and treatment dose. In the investigator's study, eligible TRD subjects will have a diagnosis of major depressive disorder with a suboptimal response to an adequate dose and duration of at least two different antidepressant treatment categories. These subjects will also have had exposure and transiently (non-durably) responded to non-invasive neurostimulation. The investigator anticipates that severely Treatment Resistant Depressed (TRD) Subjects with IpCS of the dorsolateral prefrontal cortex will show a significant decrease in depression symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at four months post-implant when compared to baseline. The investigator will enroll up to 20 subjects with severe refractory depression in an open trial, followed for up to one year. Depressive and cognitive symptoms will be rated periodically to assess the safety and efficacy of this procedure.
NCT05393622 — Depression Severe
Status: Recruiting
http://inclinicaltrials.com/depression-severe/NCT05393622/
Feasibility, Acceptability, Appropriateness, and Preliminary Effectiveness of "Thinking Healthy Programme" for Perinatal Depression in Nepal: A Pilot Cluster Randomized Controlled Trial
As many as 1 in 3 women in Nepal suffer from perinatal depression however, they often go unidentified and untreated. Lack of knowledge limited trained human resources, and unavailability of specific maternal mental health services are some of the major barriers impeding help-seeking. To mitigate this gap, the World Health Organization recommended Thinking Healthy Programme (THP), a psychological intervention that can be delivered by non-specialists and has been proven effective for perinatal depression in a resource constrained context. The THP has already been translated and adapted to Nepali context. In this study, the investigators plan to pilot test the intervention and assess its feasibility, acceptability, appropriateness, and preliminary effectiveness when delivered by the Female Community Health Volunteers (FCHVs). The FCHVs are cadre of Nepal Government mobilized for the prevention and promotion of maternal and child health in the community level.
NCT05393479 — Perinatal Depression
Status: Active, not recruiting
http://inclinicaltrials.com/perinatal-depression/NCT05393479/
TBS Treatment for Treatment-Resistant Depression: a Randomized, Sham-Controlled Trial
Depression is a highly disabling disease that is prevalent throughout the world. The treatments proposed and studied to date have shown to be partially effective in treating this condition. Neuromodulation strategies have been used as an alternative, especially for refractory and challenging cases. In this context, studies investigating the effectiveness of transcranial magnetic stimulation, including the theta burst stimulation (TBS) modality, have been increasing in number. However, there is still a lack of information seeking to explore the maximum effectiveness in the TBS modality. Therefore, the investigators developed a new stimulation protocol consisting of 3 TBS sessions per day, with an offer of 1200 pulses per session and a 30-minute interval between sessions. The protocol will be performed for 15 days, totalizing 45 stimulation sessions. The stimulations will be directed to the left dorsolateral prefrontal cortex (F3) and will be performed in a Magventure MagPro R30 device. The investigators will select 100 patients with unipolar major depression, following previously established inclusion and exclusion criteria, and will apply the protocol randomly, dividing the patients into an active and placebo group. The research team hypothesized that the active group patients will have greater improvement in symptoms of depression assessed by the 17-item hamilton depression scale over patients of the placebo group. In addition, other scales will be used for secondary outcomes. The researchers also hypothesized that there will be no difference between patients placed in the active or placebo groups in terms of side effects.
NCT05388539 — Major Depressive Disorder
Status: Completed
http://inclinicaltrials.com/major-depressive-disorder/NCT05388539/
A Feasibility Study Evaluating an Online Physical Activity Intervention for Young Adults With Low Mood and/or Depression Engaged in Community Primary Clinical Care
Physical activity (PA) has recently been established as both a primary intervention for mild to moderate, and a secondary therapy for moderate to severe Major Depressive Disorder (MDD; Fortier et al., 2020). Those with mental health disorders do not on average achieve recommended levels of PA (Hallgren et al., 2016), and exercise prescription is extremely lacking in clinical care (Stanton, Reaburn, & Happell, 2015; Stanton et al., 2018). Theory-based behavioural interventions have proven to be an effective tool for improving physical activity levels in clinical populations (Glowacki, et al., 2017; Stanton et al., 2015). More research is needed to understand PA intervention effectiveness for MDD patients (Glowacki et al., 2017), support integration of such behavioural treatments with primary care (Lederman et al., 2017), and address growing concerns regarding mental health during the global pandemic and beyond (Boyce, 2021). This community-based study examines the feasibility of a co-designed, 10-week, asynchronous, web-based beta platform PA intervention for patients with experience of low mood and/or mild to moderate depression, and will provide important parameters for a future randomized-controlled trial (RCT). Primary outcome measures will focus on acceptability and feasibility, including recruitment and retention rates. Secondary measures will include physical activity and depression symptom severity. Behavioural predictors of PA are to be evaluated as tertiary outcomes. Questionnaires will include an adapted participant experience measure, Godin Leisure-Time Exercise Questionnaire, and the Patient Health Questionnaire-9. This study features a controlled baseline, post-intervention evaluative design with an embedded quantitative process evaluation with a waitlist control. Participants will be young adults with experience of low mood and/or mild to moderate depression, 19-30 years of age, with access to a device with internet, English speaking, living within British Columbia, CAN., and falling below the minimum Canadian recommendations for PA. Study recruitment will primarily be facilitated by multiple youth mental health primary and community care clinics. This study will contribute to understanding of acceptable, efficacious, behaviour-based and mobile health intervention approaches for young adults with depression. It will also provide young people with a platform to share invaluable feedback to direct innovations in their own alternative care and mental health treatment. If outcome benchmarks set based on previous literature are met or exceeded for each of recruitment, retention, and acceptability, and depressive symptoms trend downwards for intervention participants, then a future randomized controlled trial exploring principally mental health outcomes will be recommended.
NCT05386745 — Inactivity, Physical
Status: Completed
http://inclinicaltrials.com/inactivity-physical/NCT05386745/
Psilocybin Versus Ketamine - Fast Acting Antidepressant Strategies in Treatment-resistant Depression
The main goal is to compare the antidepressant effects of psilocybin and ketamine in patients with TRD versus the antidepressant inactive substance midazolam. The primary endpoint will be the antidepressant effect on the Montgomery- Asberg Depression Rating Scale (MADRS) 24 hours after treatment, the key secondary endpoints being the duration of antidepressant effect, the number of responses and remissions, and the time to standard antidepressant treatment during 3 months of observation. The exploratory part of the study aims to monitor changes in the functional brain states using simultaneous EEG / fMRI, before treatment versus 1 day and 1 week after. Based on literature data and recent data from healthy volunteers who participated in a previous study with psilocybin, the investigator will correlate antidepressant effects of drugs (using psychometric scales and reactions to emotionally salient stimuli (eye tracker)) with entropy and functional connectivity measures. Finally the investigator will explore the role of plasmatic neurobiological biomarkers in depression (BDNF, prolactin, ACTH and oxytocin).
NCT05383313 — Treatment Resistant Depression
Status: Recruiting
http://inclinicaltrials.com/treatment-resistant-depression/NCT05383313/
Better Sleep in Psychiatric Care - Clinical Feasibility and Preliminary Effects of CBT for Insomnia in a Mixed Psychiatric Sample at an Outpatient Clinic
Between 50-80 percent of patients in psychiatry have insomnia-type sleep problems. In addition to reduced quality of life and impaired function, sleep problems can aggravate other psychiatric problems and increase the risk of relapse into, for example, depression. According to international guidelines, cognitive behavioral therapy for insomnia (CBT-i) should be used as the first choice for treatment of insomnia. In practice, however, it is very uncommon for psychiatric patients to be offered CBT-i, instead most are treated with sleep medications. There is also a lack of research studies evaluating CBT-i in regular clinical practice. This pilot study investigated the feasibility of a group treatment with CBT-i at a psychiatric outpatient clinic in Stockholm for patients with depression, bipolar disorder II, anxiety syndrome and PTSD. Changes in symptoms of insomnia, depression, and anxiety after treatment were also investigated. Patients with self-perceived sleep problems were offered a six-session group treatment based on CBT-i. The primary outcome was clinical feasibility, defined as: the influx of patients sufficient to start at least one group per semester (at least 8 patients); at least half of included patients participate in the first session; patients participate in at least half of the sessions; less than half of the patients drop out of treatment; group leaders find the treatment manual credible, easy to use and want to continue working with it after the study is completed. Secondary outcomes were changes in insomnia symptoms, and changes in symptoms of depression and anxiety.
NCT05379244 — Anxiety Disorders
Status: Completed
http://inclinicaltrials.com/anxiety-disorders/NCT05379244/
Technology and Emotion Study "TECH-E": Randomized Controlled Trial of MoodRing Compared to Usual Care: Mobile Monitoring of Adolescent Depression Phase II
The MoodRing intervention is a mobile application for adolescents, parents, and an accompanying web-based clinician portal which enables adolescents to monitor their mood through the use of passively collected smartphone data. This randomized controlled trial will evaluate whether MoodRing as compared to usual care improves the quality of depression management.
NCT05376358 — Depression in Adolescence
Status: Active, not recruiting
http://inclinicaltrials.com/depression-in-adolescence/NCT05376358/
A Pilot Study of iTBS in Bipolar I Depression
A multisite, open label pilot study to investigate the efficacy and safety of a novel accelerated intermittent theta-burst stimulation (iTBS) protocol while assessing for changes in neuroimaging biomarkers associated with treatment response.
NCT05375214 — Bipolar Depression
Status: Completed
http://inclinicaltrials.com/bipolar-depression/NCT05375214/
Comparison of a Mobile Digital Health Intervention Versus Waitlist Control for the Treatment of Depression and Anxiety: A Randomized Controlled Trial
Although mobile applications ("apps") for mental health are popular and widely available, little is known about how well they actually help people with common mental health symptoms of depression, anxiety, and stress. We are partnering with a commercially available app to test how well this app helps people's mental health over 8 weeks. Participants will be randomly assigned (like flipping a coin) to two groups: (a) using the app, (b) no app until after 8 weeks. We will ask participants to complete online surveys about their mood and well-being so we can better understand the effects of these different treatments.
NCT05373329 — Depression, Anxiety
Status: Completed
http://inclinicaltrials.com/depression-anxiety/NCT05373329/
Evaluation of Voice Analysis Technology in Detecting and Managing Depression and Anxiety in Patients Undergoing Cardiac Rehabilitation
The purpose of this study is to learn if a voice analysis smartphone app which detects anxiety and depression could be used along with cardiac rehabilitation to improve results compared to cardiac rehabilitation alone.
NCT05371470 — Myocardial Infarction
Status: Recruiting
http://inclinicaltrials.com/myocardial-infarction/NCT05371470/