Bipolar Disorder Clinical Trials in Canada

The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder. To do this, some of the participants in this study will receive treatment with active iTBS stimulation, while others will receive sham iTBS stimulation. Participants will come for 30 days of either active iTBS or sham iTBS, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion. Read Less

While effective interventions for depression exist, their success rates are unsatisfactory and their provision is haphazard. The Canadian Depression Research and Intervention Network (CDRIN) Maritimes Depression Hub will improve the delivery of care and the quality of outcomes for youths, adults and seniors with depression across the Maritimes. The investigators will establish an integrated system of assessment, treatment, research and education related to depression with the active involvement of those with lived experience. The establishment of a patient registry is a key step that will facilitate evaluation and reform of current services, integration of patient choice and community resources into treatment programs, monitoring long-term outcomes, and development of more effective treatment approaches through research. The registry will facilitate research that will include validation of new diagnostic and outcome measurement tools, low-cost clinical trials and collaborative projects with national and international partners. Educational programs will involve training the next generation of researchers, those with lived experience, clinicians, and health system managers in critical appraisal and will facilitate their involvement in research. The registry, the proposed systematic measurement of outcomes and the broad dissemination of information and skills will improve the quality of research and of care as well as the experience of patients and their families. The need for a registry: It is increasingly recognized that major advances in the treatment of mental disorders will require large scale clinical research. Recently demonstrated ways of completing large-scale research with finite resources include the routine use of electronic health records (EHR), data linkage and randomized registry trial. Use of EHR is the most efficient way of rapidly obtaining large amounts of information. However, EHR cannot completely exclude confounding by indication and other unmeasured variables. Therefore, tests of treatment effects require experimental designs that cannot be replaced by routine health records data. The gold standard for testing the effects of treatment in an unbiased way is the randomized controlled trial (RCT), where measured and unmeasured confounders are balanced through the randomization process and any remaining confounding is due to chance alone. RCTs are valued as the highest level of evidence, but are costly and take significant time to be completed, partly because of the need to screen a large group of individuals to identify eligible participants. The most efficient unbiased test of interventions, new treatment modalities and novel ways of treatment delivery is a method that combines EHR use with the randomized controlled trial (RCT) methodology: the randomized registry trial (RRT). The RRT takes advantage of a registry of individuals with available information to identify a large number of individuals suitable for an RCT. The RRT approach is efficient especially if the same information (e.g. diagnosis and treatment history) is used repeatedly for different purposes. The same information can be used for clinical purposes, service improvement and multiple research projects. RRT will allow obtaining answers about the efficacy of new treatments and management strategies significantly faster and at a much lower cost than traditional RCTs. Therefore, the investigators propose to establish a registry that has the capacity to conduct RRTs. The proposed registry will be integrated with similar efforts across Canada. Jointly, this collaborative network of registries will facilitate fast and economical testing of new treatments, which is urgently needed to advance the therapeutic options for people with depression and related conditions. Read Less

Severe mental illness (SMI) refers to the most burdensome psychiatric conditions. The need to pre-empt the onset of SMI is pressing because once SMI develops, quality of life is poor and available treatments have limited efficacy. Most risk factors for SMI are either unchangeable (e.g., genetics) or difficult to alter (e.g., low socio-economic status). In contrast, cannabis use is one specific risk factor that could be avoided. Certain individuals are more vulnerable to the harmful effects of cannabis. Genetic factors can help us identify these high-risk individuals. One in three individuals are carriers of a higher-risk genetic variant, and cannabis users with this genotype are at up to 7-fold increased risk of developing schizophrenia. In our study, genetic counselling will be provided to participants by a board-certified genetic counsellor. During the genetic counselling session, participants will have the option to receive their genotype. Participants will be counselled regarding their individualized risk of developing and of not developing SMI based on family history, whether or not they choose to use cannabis, and genotype (if the participants accept the genetic test results). The investigators hypothesize that this intervention will reduce exposure to cannabis compared to the youth who are not offered the intervention. Read Less

Severe mental illness such as schizophrenia and mood disorders typically develops at a young age and can cause life-long disability. Currently available treatments cannot cure severe mental illness. This makes it important to find ways to prevent severe mental illness in young people before it has a chance to develop. This research study will pilot a new preventive intervention for young people who are at high risk of developing severe mental illness. The investigators will target early preceding factors (the 'antecedents') to severe mental illness which includes anxiety, unusual hearing and visual experiences, the loss of previously acquired abilities, and sudden and unpredictable changes in mood. These antecedents strongly predict an increased risk of developing severe mental illness. They are often impairing and distressing to the individual but can be improved with self-management skills and parent training, and they are present in the individual years before the onset of severe mental illness which makes them an ideal target for early intervention. The goal is to intervene early enough in the young person's life that severe mental illness can be prevented, hopefully leading to a happy, healthy and productive adulthood. The investigators want to test the acceptability and short-term efficacy of this new preventive intervention. Read Less

Bipolar disorder (BD) is a lifelong condition characterized by recurrent episodes of depression and (hypo)mania. Periods of chronic and recurring depressive episodes are more common and can be severely disabling. Effective treatments exist; however, a significant portion of bipolar depressed patients do not respond to or have difficulty tolerating many of these interventions and thus look beyond established treatments to achieve symptom relief. Cannabidiol (CBD), a chemical from the Cannabis sativa plant, has shown to have some beneficial effects on mood symptoms in a few small studies which assessed its effects in other mental and physical health conditions, but no large studies have been conducted to assess its safety and efficacy in bipolar depression. Additionally, several clinical studies have shown CBD to be safe and tolerable. The primary objective of this study is to assess the effectiveness, safety and tolerability of cannabidiol in patients with bipolar depression (BD I or BD II) who have not responded to adequate trials with at least one first-line treatment for bipolar depression in comparison to those who will be treated with placebo. Placebo is an inactive substance that looks identical to the study medication but contains no therapeutic ingredient. This study is a randomized (like the flip of a coin), double-blind (you and the study team will not know which treatment arm you receive) study in which participants will receive either CBD or placebo added to their current treatment. Participants will have 5 clinical appointments and a phone appointment over a period of 10 weeks. Read Less

This study seeks to bridge the knowledge-to-action gap regarding psychosocial treatment "dosing" for youth with and/or at familial risk for bipolar disorder (BD). In psychiatry, pragmatic collaborative decisions between patient and care provider about pharmacological titrations and tapers are common. Less frequently are there considerations made regarding the pragmatic dosing of psychosocial interventions. Whereas some youth clearly require full/"high-dose" treatment, others may benefit from "lower-dose" interventions, alongside re-evaluation of dosing needs over time. Furthermore, there is a subset of youth who do not require or do not want the intensity and frequency of treatment that current interventions provide. This research presents a unique opportunity to better understand different levels of care within a subspecialized outpatient mental health clinic serving youth with and/or at familial risk for BD who vary greatly in terms of risk indicators, type and severity of symptoms, associated distress, and compounding functional impairment. Read Less

The study intervention is DBT adapted for youth with and/or at familial risk for bipolar disorder. Participants will have completed one full year of DBT in a previous study. This study is examining use of booster sessions. It is delivered in the form of individual sessions and skills sessions, based on the preference of the study participant. The study participant may also receive skills coaching via phone. There is no standard reference therapy/comparator against which the study intervention is being compared. Read Less

Dialectical behavior therapy (DBT) will be conducted over 1 year in youth with and/or at familial risk for bipolar disorder (BD). DBT will be divided into two modalities: 1) DBT skills training; and 2) DBT individual therapy sessions. Skills training sessions will incorporate the 5 standard adolescent DBT modules: mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills and an additional module on psychoeducation about DBT and BD. This study seeks to build upon the knowledge base in this area by offering DBT to youth with and/or at familial risk for BD with an emphasis on predictors and mediators of treatment outcomes. Read Less

Psychosis is a disabling condition that typically has its onset in adolescence and early adulthood. Many young people with psychosis have difficulty navigating services or are reluctant to engage in treatment until their illness becomes an emergency. Consequently, nearly half of all new psychotic disorders are diagnosed in the emergency department (ED). Despite the rationale and evidence for early psychosis intervention (EPI), around half of youth do not access these services. The investigators will use short message service (SMS)/text messaging, a low-cost, low-complexity, youth-friendly approach, to improve transitions in care from the ED and related acute services to EPI services, investigating the intervention's effect on attendance at the first consultation appointment, longer term service engagement, and system-level outcomes. The investigators will also evaluate cost-effectiveness and user perspectives of the intervention. Read Less

The sleep-wake cycle is severely disrupted during an episode of mania. Often mania is treated with medications that can come with significant side effects. Years of patient and family engagement with this population have revealed great interest in therapies targeting the sleep-wake cycle. However, there is still a lack of studies to support using these treatments for mania. Patient partners are especially interested in two specific therapies for mania, blue-blocking glasses and time-restricted eating, because of their perceived feasibility and safety. This pilot study will formally investigate the feasibility and effectiveness of these therapies for participants with mania, an understudied population that faces many difficulties even after recovery. The pilot study will collect interviews to identify barriers and ways to better support patients with mania using the therapies. The study will also investigate how well these therapies can treat manic symptoms and restore sleep-wake cycles by tracking symptom rating scales and measuring activity levels. Results from this pilot will be used to direct a larger study that will use a state-of-the art design to test the effectiveness of both therapies alone and in combination. Read Less

This is a randomized clinical trial to test the effectiveness of combining a proven psychological intervention called behavioural activation therapy alongside esketamine treatment for treatment resistant major depressive episodes in individuals with major depressive disorder or bipolar disorder. Encouraging participants to practice new behaviours while their mood is improved through esketamine treatment may lead to more lasting recovery from depression. Read Less

The goal of this pilot clinical trial is to assess the feasibility of conducting a full-scale study to learn if a new youth-adapted Narrative Enhancement and Cognitive Therapy (NECT-Y) reduces self-stigma in youth living with bipolar disorder or multiple mental health conditions. The main questions it aims to answer are: * What is the feasibility of conducting a definitive clinical trial in terms of recruitment success, study retention/compliance, treatment retention/compliance, and absence of serious adverse events? * Can facilitators deliver the adapted NECT-Y intervention with fidelity? * What is the acceptability of the newly adapted NECT-Y intervention among youth participants and facilitators? Researchers will compare NECT-Y to treatment as usual (TAU). Participants will take part in a virtual 14-week NECT-Y group intervention or receive TAU. They will also complete questionnaires at three time points (baseline, post-treatment, and follow-up). Read Less