Active clinical trials for "Bipolar Disorder"

The aim of the AKTIBIPO VALIDATION study is to evaluate the effect of the Mindpax monitoring and microeducation system in patients with bipolar disorder (BD). Up to 130 participants (BD patients) who participated previously in the observational AKTIBIPO study, as well as new patients (DeNovo) will be enrolled for a follow-up period of 12 months. All participants will wear the wrist actigraphy device and use the Mindpax mobile application on their mobile phone. Through the application, the patients will fill in the weekly mood self assessment questionnaire (ASERT) and receive evidence-based health microeducations aimed at understanding the bipolar disorder and associated risk factors. Apart from general psychoeducation, the participants will receive additional individualized targeted health microeducation when the system detects deviation from individual patterns of mood, activity and sleep. The outcomes will evaluate the subjective and objective impact of system usage on self-reported and clinical outcomes.

Interpersonal and Social Rhythm Therapy (IPSRT) is a type of psychotherapy that applies social rhythm theories in bipolar disorder. The purpose of IPSRT is to stabilize people's social routines (daily routines, sleep-wake balances), gain insight into the two-way relationship between interpersonal events and mood, and increase their satisfaction with social roles. This study was planned as a follow-up study in a quantitative, randomized controlled experimental design, aiming to determine the effectiveness of Peplau's Interpersonal Relations theory-based IPSRT applied to individuals with bipolar disorder to determine the effect on biological rhythm, interpersonal relationships and relapse frequencies. Pre-intervention pre-test, post-intervention post-test and follow-up scheme will be used. To carrying out of this study, first of all, intervention and control groups will be formed by randomization according to gender and bipolar type (I-II), using the Introductory Information Form, Young Mania Rating and Hamilton Depression Rating Scales from individuals with bipolar disorder registered to the Community Mental Health Service (CMHS). As a pre-test (Introductory Information Form, Young Mania Rating Scale, Hamilton Depression Rating Scale, Biological Rhythm Assessment Interview, Interpersonal Competence Scale) to the intervention and control groups, Peplau Interpersonal Relations based IPSRT will be applied to the intervention group, and the control group will be given a CMHS and will also continue the treatment. IPSRT will take 40-45 minutes twice in a week and will be conducted in 10-12 individual meetings in total. Immediately, 1 month and 3 months after the interviews, post-tests will be applied to the intervention and control groups With this study, the biological rhythms of IPSRT individuals based on Peplau Interpersonal Relationship Theory in bipolar disorder will be regulated and the frequency of relapse will decrease. In addition, individuals with bipolar disorder, which is one of the lifelong mental illnesses that cause stigmatization, will continue their lives in the community, their functionality will increase in their work life, school life and social life, and hospitalization will decrease

The protocol involves functional Magnetic Resonance Imaging acquisitions immediately before and after Low Field Magnetic Stimulation treatment on two separate days in a sham controlled, randomized trial, in order to assess the physiologic effects of Low Field Magnetic Stimulation on brain function in a geriatric population with bipolar depression.

The purpose of the registry is to record incidence of adverse events during treatment with clozapine in patients suffering from bipolar disorder.

The purpose of the Pilot Study Investigating the Efficacy of Minocycline and n-acetylcysteine for Bipolar Depression is to test the effectiveness of minocycline, n-acetylcysteine, and combined minocycline and n-acetylcysteine pharmacotherapy in order to fill the gap in treatments for bipolar depression. The treatment of bipolar depression remains the greatest unmet need in the management of this lifelong and chronic psychiatric disorder.

People have had to make a lot of changes to their lives due to the COVID-19 health crisis. Most experts agree that social distancing and other safety measures have taken a toll on people s mental health. Amish and Mennonite communities often have large families. They may have limited access to health care. Their lifestyle is based on interaction and group events rather than technology. So people in Amish and Mennonite communities may experience the pandemic in their own special ways. Objective: To describe the relationship between stress related to the pandemic and self-rated measures of mental health symptoms and distress among Amish and Mennonite people with bipolar disorder and related conditions, and their family members. Eligibility: Adults ages 18 and older who are taking part in the NIMH AMBiGen study (80-M-0083). Design: Participants will be mailed 4 surveys. One survey will ask about depression symptoms. One survey will ask about mania symptoms. One survey will assess a broad range of psychological problems. One survey will assess the impact of COVID-19 on their mental health. They will fill out the surveys 4 times over 24 months. The surveys will not include participants names, just codes. This will help protect privacy. Data collected in 80-M-0083 will be used. This includes data about participants genes, medical conditions, and assessments. Participants will get an 800 number they can call to speak to the research team. They can also write to the team if they prefer. Participants who wish will get referrals for mental health services. Participation will last up to 24 months. There will be an option for recontact in the future.

While there are effective treatments for depression available, some patients do not see results with these options. Often, these patients are referred to electroconvulsive therapy (ECT) which has drawbacks such as adverse side effects, cost, and limited access. Recent research shows that intravenous ketamine may be an alternative option for these patients due to its rapid antidepressant effect sustained with multiple treatments. This study will recruit 240 participants from the ECT waiting list at the five participating hospitals, and randomize them to either the ketamine or ECT treatment arm. Participants in the ketamine treatment arm will receive 0.5mg/kg ketamine intravenously (IV) over 40 minutes as described in the study schedule. Participants in the ECT treatment arm will receive ECT as described in the study schedule and as decided by their treating physician. Throughout the study, clinical, neuroimaging, molecular, and cognitive assessments will be conducted. The aim of this study is to show that compared to ECT, ketamine treatment produces faster results, has less side effects, requires less or shorter hospitalizations, and is less expensive. The measures collected throughout the study (clinician scales, self-reports, blood samples, and neuroimaging) may help with predicting if future patients will respond to ECT or ketamine. This could lead to faster, more effective treatment for patient with depression.

To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS) as an antidepressant treatment in subjects with mood disorders.

Bipolar disorder is a frequent condition in the general population with a high morbimortality, which consists in dysfunctional temporal fluctuations between different mood phases ranging from depression to manic episodes with frequent subsyndromal symptoms between them. Usually during these phases, the subjects have a lack of insight about the diagnosis and symptoms. Besides the pharmacological treatment, additional psychological interventions have shown to improve the long-term outcome of the disorder, yet taking into account the limited resources currently available, its general implementation is still difficult and costly. Among these interventions, group psychoeducational programs have proved to be cost-effective in helping patients recognize early signs and symptoms in order to prevent full blown episodes which very usually are associated with a high morbidity and hospital admissions. On the other hand, numerous projects have tested the potential benefits of new technologies such internet in the treatment of bipolar and psychotic disorders patients using either online signs and symptoms monitoring or web-based psychoeducational programs, yet to the investigators knowledge, none of them have integrated both approaches in one single intervention. The hypothesis that, combining both interventions (signs and symptoms monitoring along with psychoeducational contents) in a single smart-phone application will prove to be at least equal or superior in terms of efficacy comparing to the standard treatment, seems promising, given the fact that both approaches have independently demonstrated their efficacy in the same population. This could extend the range of the patients in whom this kind of additional interventions could be implemented; preventing relapses, suicide attempts, consultations and hospitalizations at a much lower cost.

Differentiation between major depressive disorder (MDD) and bipolar disorder (BD) as soon as possible in the patient journey represents a major clinical issue. When the patient is in a depressive phase, the symptoms are similar between the two pathologies and the current clinical scales fail in distinguishing them. Physicians often report this difficulty and as a consequence, the mean time from onset to bipolar disorder diagnosis is currently 7.5 years. These diagnostic delays and misdiagnosis lead to damaging consequences for patients and their loved ones: worsening of symptoms, comorbidities, suicide risk and inadequate care resulting in severe impairment in social and occupational functioning. Faced with these high expectations for accurate diagnostic methods for an earlier management of psychiatric patients, the combination of relevant clinical features and biomarkers could stand for a solution, leading to a personalised approach in patients with mood disorders. In a first clinical discovery study, a panel of RNA biomarkers in the blood of patients with a major depressive episode (MDE) has been identified, allowing to differentiate bipolar disorder from MDD (unipolar depression). These biomarkers are based on RNA modifications, namely RNA editing, that could be identified using molecular biology, NGS and artificial intelligence. This panel constitutes EDIT-B test, which is based on Alcediag's proprietary and patented biomarkers and algorithms. The present study aims to validate the biomarker signatures proposed by Alcediag by measuring the association between the modifications of the RNA editing and major depressive disorder/ bipolar disorder diagnosis, in patients with a MDE in real-life setting pilot centres.