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Mania clinical trials

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NCT ID: NCT06426134 Not yet recruiting - Psychosis Clinical Trials

Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS

KISSeS
Start date: July 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if a ketone drink can improve signs and symptoms of patients with a schizophrenia-spectrum disorder (SSD), or a bipolar-spectrum disorder (BD). The main questions it aims to answer are: Does a ketone drink improve information processing in patients with SSD/BD? Other questions it aims to answer are: Does a ketone drink improve cognitive functioning in patients with SSD/BD? Does a ketone drink improve metabolism and inflammation in patients with SSD/BD? Research will compare the effects of the ketone drink with that of an isocaloric carbohydrate drink in the same patients ('cross-over'). Participants will: 1. drink a ketone drink and (after a wash-out period) an isocaloric control drink; after each drink: - EEG to determine information-processing parameters (PPI and P300) - cognitive tests - visual analog scale of mood, energy levels, ability to focus - indirect calorimetry to determine use of energy substrate - blood draws 2. for 5 consecutive days: - wear a continuous glucose monitor (CGM) - wear a non-invasive passive sweat biomarker sensor (EnLiSense device) - register a diet and nicotine diary - saliva sampling (max. 4x/day, only on both intervention days)

NCT ID: NCT06129500 Recruiting - Bipolar Disorder Clinical Trials

CBT for Problematic Impulsive Behaviours in Bipolar Disorder: A Case Series / CBT-PIB

Start date: August 17, 2023
Phase: N/A
Study type: Interventional

The goal of this case series is to explore whether a talking therapy, specifically Cognitive Behavioural Therapy (CBT) is acceptable and feasible in the management of mood-driven impulsive behaviours in people with bipolar disorder (BD). The main questions it aims to answer are: - Whether CBT Is a feasible intervention for participants with BD who report mood-driven, problematic impulsive behaviours. - Whether CBT for mood-driven, problematic impulsive behaviours (CBT-PIB) is acceptable to service users with BD and therapists. - Whether clinical outcomes are consistent with the potential for this novel intervention to offer clinical benefit to participants with BD. The study also hopes to: - conduct a preliminary examination of the safety of CBT-PIB and the research procedures. - gather information on the potential mechanisms of action of CBT-PIB and, - gather information on the types of mood-driven impulsive behaviours individuals with BD may seek support for. Participants will: - be offered up to 12 individual sessions of CBT focusing on mood-driven impulsive behaviours. - be asked to complete a battery of self-report measures (5) when they enter the study and at the start and end of treatment. - be asked to track mood and impulsive behaviours by completing a brief set of measures (3) weekly during the two-week baseline phase, the intervention phase and the 2-week post-intervention phase. - be asked to complete a survey on the acceptability of the intervention and - be invited to an optional semi-structured interview on their research experience.

NCT ID: NCT05956340 Recruiting - Bipolar I Disorder Clinical Trials

A Study of Spoken Language in Mania

Start date: April 19, 2023
Phase: N/A
Study type: Interventional

This research is being done to find if there are changes with voice and speech during episodes of mania.

NCT ID: NCT05766007 Recruiting - Schizophrenia Clinical Trials

Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum

LAMP
Start date: August 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about how long-acting injectable antipsychotic (LAIA) medications are affected by the changes that take place in the body during pregnancy, and how much an unborn baby is exposed to. The investigators are also interested in the amount of these drugs that enters into breastmilk and taken by babies during breastfeeding. In addition to their regular clinic visits to receive long-acting mental health medicine injection, participants will be invited for up to four study visits between day 2 and 14 after the injection. This will happen only once during pregnancy, and once during the breastfeeding period to collect a few drops of blood on special filter paper card from the finger using safety lancet. A few drops of breastmilk will also be collected. Immediately after delivery, a few drops of blood will be collected from the mother, umbilical cord and the baby heel. The investigators will use these samples to determine the amount of the drug in the body during pregnancy and compare this to the amount during the breastfeeding period. Additionally, every month during the third trimester, and during the first 3 months postpartum, participants will complete a questionnaire (using the Liverpool University Neuroleptic Side Effect Scale) to document how they are feeling. Clinical improvement will be documented by the primary care provider using the Clinical Global Impressions Scale. Findings from this study are expected to help healthcare providers to understand these drugs better so that they can make informed decisions about if and how to use these drugs in women who become pregnant or are breastfeeding.

NCT ID: NCT05703711 Active, not recruiting - Depression Clinical Trials

Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa

Start date: June 30, 2023
Phase: N/A
Study type: Interventional

In West Africa, most people with serious mental illness receive care from traditional or faith healers at prayer camps. The stepped-wedge cluster randomized trial aims to evaluate the effectiveness of a dual-pronged intervention package comprised of a mobile health program designed to train healers to deliver evidence-based psychosocial interventions combined with pharmacotherapy delivered directly to the patients at their prayer camps via a visiting nurse in Ghana.

NCT ID: NCT05622552 Recruiting - Manic Episode Clinical Trials

Effect of tDCS Combined With Pharmacological Treatments for Bipolar Mania

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to conduct a randomized double-blind controlled trial to explore the efficacy and safety of transcranial direct current stimulation (tDCS) in the treatment of manic episode (ME) and analyzes the brain functional connectivity to construct the therapeutic effect prediction model of tDCS for ME. The main questions it aims to answer are: - A randomized double-blind controlled trial is conducted to clarify the efficacy and safety of tDCS combined with pharmacological treatments in the ME. - A therapeutic effect prediction model of tDCS for ME by using functional near-infrared spectroscopy to evaluate brain function. Participants will be receive: - clinical data interview and clinical symptom assessment. - the functional near-infrared spectroscopy (fNIRS) to analysis brain functional connectivity. - tDCS stimulation, which was performed once a day sessions of active or sham anodal tDCS to the right dorsolateral prefrontal cortex and Cathode to the left OFC (2 mA, 20 minutes, 10 sessions). In the active group, current stimulations were gradually ramped up to 2 mA (in 30 seconds) intensity for 20 minutes, once a day, for 10 days. For sham stimulation, the procedure was identical, except that the current was gradually ramped up to 2mA and rapidly down to zero (in 30 seconds), thus leading to the same initial sensations of tDCS.

NCT ID: NCT05444907 Recruiting - Parkinson Disease Clinical Trials

Deep Brain Stimulation-Induced Mania in Parkinson's Disease

BPD_DBS
Start date: May 25, 2021
Phase:
Study type: Observational

Parkinson's Disease (PD) is a common and debilitating neurodegenerative disease. While medication can alleviate its symptoms, not all patients will adequately respond to medical therapy. For these cases, deep brain stimulation (DBS) has been used to improve symptoms and quality of life. Nevertheless, this approach is, in some cases, associated with incapacitating neuropsychiatric side-effects, including mood disturbances, such as DBS-induced mania. While this condition has important functional short- and long-term consequences for quality of life and prognosis, its pathophysiology is still poorly understood. In this project the investigators propose to conduct a retrospective and naturalistic study in PD patients in whom DBS stimulation resulted in mania or mixed state episode, to clarify if specific sociodemographic and clinical predictors, namely stimulation parameters and target locations, might be associated to the occurrence of this neuropsychiatric adverse event. Additionally, the investigators aim to clarify if the occurrence of DBS-induced mania results from the impact of specific stimulation parameters and/or target locations in functional connectivity networks. To explore this question, the investigators will use different neuroimaging analysis methods termed lesion topography analysis and lesion network mapping, in order to compute maps of the stimulated regions topography and the functional networks that are associated with DBS-mania, respectively. The data that will be analyzed in this project, including neuroimages, will be obtained retrospectively, by different Movement Disorders and Functional Surgery Groups in the context of Deep Brain Stimulation, and that has been collected according to their usual clinical practice.

NCT ID: NCT05210062 Recruiting - Depression Clinical Trials

Impact of Closely Grouped, Iterative Exposures to Suxamethonium During ECT on the Sensitization to NMBA and the Development of Protective Antibodies

SismoSens
Start date: January 27, 2022
Phase:
Study type: Observational

Acute per-anesthetic hypersensitivity reaction (HSA-PA) is a rapidly occurring systemic reaction following injection of a drug during anesthesia (mortality between 3 and 9%). The substances responsible for these reactions in France are Neuro-Muscular Blocking Agents (NMBA) in 60% of cases. The main mechanism mentioned is an immediate systemic hypersensitivity immune reaction (anaphylaxis). The mechanism of immunization to NMBA is not yet understood. Electroconvulsive therapy (ECT) is a long-standing therapeutic approach still widely used today, for its high efficiency, particularly in depressive syndromes resistant to antidepressants. It has an efficacy comparable (or even superior) to pharmacological treatments and improves the mortality associated with this disease. Treatment with iterative ECT sessions includes an attack phase with an average of 12 sessions over 4 weeks, with secondary spacing of sessions before switching to antidepressant treatment. These sessions are carried out in the operating room under general anesthesia, thanks to a hypnotic and a NMBA, suxamethonium, as recently recommended by the French Anesthesiology Society in 2020. ECT therefore represent an interesting model of iterative exposure of a relatively homogeneous population to a single highly sensitizing substance, which could make it possible to study the evolution of sensitization as a function of various factors, in particular cumulative exposure, for which no data is currently available.

NCT ID: NCT05206747 Recruiting - Bipolar Disorder Clinical Trials

Ottawa Sunglasses at Night for Mania Study

OSAN
Start date: September 7, 2022
Phase: N/A
Study type: Interventional

Mania is a serious condition. Symptoms of mania include decreased sleep, increased energy, changes in mood, thinking, and behavior. Dark therapy, which involves placing patients in a dark room for 14 hours overnight, can effectively treat mania, but is not practical. Dark therapy is also unpleasant. However, similar effects on the brain can be created from blocking only blue light with glasses. This preserves the wearer's ability to see and move safely. A trial of blue-blocking glasses for mania in Norway produced dramatic improvements in manic symptoms within three days of hospitalization. Mania both disrupts the sleep-wake cycle and is triggered by short and interrupted sleep. Examples of triggers include shift work and travel across time zones. Therefore, mania involves the "day-night" clock in the brain. The rhythm of the brain's clock is set by special sensors in the eye that identify daytime from blue light. If light does not include this blue spectrum, this informs the brain it is nighttime. In spite of the obvious potential of blue blocking glasses for mania, there has been no confirmatory study of this simple treatment in the five years since the initial Norwegian trial. Without a second study, this treatment will not find its way into routine clinical care. The investigators will conduct a randomized controlled trial of blue-blocking glasses for mania in hospitalized patients. The investigators will also assess activity, sleep, and saliva melatonin (a hormone secreted in the brain at night) to see how this treatment works. If our trial confirms that blue-blocking glasses are effective, this treatment could help those suffering with mania return to their life more quickly. Medications for mania can also cause serious side-effects and having glasses as a treatment option might also reduce the amount of medicine needed to get well. Blue-blocking glasses could be a low-cost non-medication treatment. The investigators will look at how they could put this treatment into practice as part of everyday care.

NCT ID: NCT04874974 Completed - Schizophrenia Clinical Trials

Feasibility of a Novel Process-based Treatment for Patients With Psychosis

PROBAS
Start date: May 10, 2021
Phase: N/A
Study type: Interventional

The purpose of this single-arm feasibility study is to develop and pilot test a novel process-based and modular group therapy approach for patients with acute psychotic symptoms in an inpatient setting.