View clinical trials related to Psychotic Disorders.
Filter by:Insight, or lack of illness awareness, is a prominent and pressing clinical concern in the treatment and recovery of patients with psychotic disorders. Impaired insight results in poor treatment engagement and adherence, more frequent hospitalizations, greater positive and negative symptoms, and poor psychosocial functioning. Addressing these complications early in the disease process may lead to altered illness course with better outcomes. To date, only a small number of nonpharmacological interventions have been developed, none of which adequately address poor insight during the first few years of psychotic illness. Further, presently available therapeutic interventions do not attend to difficulties associated with improved insight, such as depression. The purpose of this investigation is to implement a novel intervention designed to improve insight, metacognition, neurocognition, symptoms, and ultimately overall functioning in persons with early psychosis. The novel intervention will integrate a number of previously established therapeutic approaches, such as metacognitive, narrative, cognitive behavioral and motivational interviewing, and hence be labeled Integrated Metacognitive Therapy (IMT). In order to measure the efficacy of IMT, all subjects will undergo a battery of assessments in each of these domains prior to and following either a novel intervention (N = 10) or treatment as usual (N = 10) for a period of approximately six months. Throughout the study, each IMT session (N = 10, 24 sessions each) will be audio recorded, transcribed, and de-identified to allow for careful ongoing qualitative analyses of potential active and inert ingredients of the approach and ultimately the development of an IMT manual which can then be tested in a larger, more rigorous randomized control trial. This investigation will play an important role in advancing current knowledge about treating insight in early psychosis. Further, it will serve to expand upon the intervention tools available by producing a much needed treatment manual designed specifically to target insight during an illness phase crucial for positive long term outcomes in psychosis.
Obesity occurs at 2-3 times the general population rate in persons living with a psychotic illness. The risk of obesity-related serious medical conditions like diabetes and heart disease are also two to three times higher in this population. Traditional behavioral weight management approaches help more than half of these individuals to lose weight, but a significant proportion are not helped. This pilot study is intended to determine the feasibility, efficacy, acceptability, and potential clinical utility of an intervention that integrates mindfulness, acceptance, distress tolerance, and motivation and commitment combined with traditional behavioral strategies for weight loss. This is the first study to investigate such an acceptance-based behavioral intervention for weight loss in psychotic illness. The results from this study will help to determine whether future research in this area is warranted with a larger sample, over a longer period of time. Primary hypothesis: Weight loss will be greater in individuals who receive the acceptance based behavioral intervention, relative to those who receive nutritional counseling.
Clinically, many patients with AD show no response or minimal response to antipsychotics for symptoms of agitation/aggression or psychosis, or they have intolerable side effects on these medications. Antipsychotics have a wide range of side effects, including the risk of increased mortality (60-70% higher rate of death on antipsychotic compared to placebo) that led to an FDA black box warning for patients with dementia; a more recent review and meta-analysis showed a 54% increased risk of mortality. In addition, some patients show only partial response to antipsychotics and symptoms persist. For these reasons, the investigators need to study alternative treatment strategies. Currently, there is no FDA-approved medication for the treatment of psychosis or agitation in AD. The investigators innovative project will examine the efficacy and side effects of low dose lithium treatment of agitation/aggression with or without psychosis in 80 patients with AD in a randomized, doubleblind, placebo-controlled, 12-week trial (essentially a Phase II trial). The results will determine the potential for a large-scale clinical trial (Phase III) to establish the utility of lithium in these patients.
The proposed pilot study will compare minocycline augmentation with clozapine in individuals with high vs low inflammation as measured by CRP. Investigators hypothesize that minocycline will be well tolerated and will result in an improvement in the symptoms of schizophrenia, cognition, as well as improve the quality of life for patients preferentially in patients with high CRPs. Investigators plan to use a variety of different scales to measure improvement in the varying symptoms of schizophrenia as well as cognitive function, which will be administered to patients at three week intervals for a total study time of twelve weeks. Investigators hypothesize that minocycline could prove to be an effective, well tolerated, and inexpensive medication for treatment resistant patients with schizophrenia whom have particular difficulties with social interactions, obtaining and maintaining employment, and overall quality of life. Furthermore, investigators hypothesize that the data obtained in this study will contribute to the ongoing exploration of the role of inflammation in the brain of patients with schizophrenia and help understand and target the role of various inflammatory markers in the pathophysiology and treatment of treatment resistant schizophrenia.
With medication, many individuals with psychosis experience a remission from hallucinations and delusions, the most salient aspects of the disorders. However, alleviation of these symptoms is not associated with recovery of everyday functioning in important areas like working, socializing, maintaining the household, and recreational pursuits. The reason these difficulties with functioning persist is that psychotic disorders are associated with considerable difficulties with cognitive functions such as attention, memory, and planning. Cognitive impairments persist even when the delusions and hallucinations are treated, and in fact account for most of the persistent impairments in functioning. Recently, psychological treatments called Cognitive Remediation have been developed and tested in research settings, where techniques that train the brain to process information more efficiently result in very large improvements in cognition. However, there are two major hurdles remaining as investigators attempt to determine how this treatment can graduate from research laboratories to become a widespread clinical treatment. First, cognitive remediation in research settings is very intensive: it requires frequent visits with specialized therapists who deliver the treatment to groups of patients. This makes it quite difficult for people with psychosis, who might not have the financial means or motivation to travel and who might be experiencing symptoms that make it unlikely that they will attend groups, to participate fully if the traditional research techniques were directly transported to a clinical setting. The second hurdle is that even though cognitive remediation improves cognition, it does not always transfer to everyday behavior changes. Investigators recently found that this transfer to functioning is more meaningful and durable when using additional techniques that teach people skills such as being aware of your own thinking and to use multiple, flexible problem solving strategies. The goal of this project is to address these limitations by testing a new development in the treatment: delivering cognitive remediation to participants in their homes, with cognitive exercises and therapist support provided online. The techniques are the same as successful in-session cognitive remediation, but those with psychosis can engage in the intervention at home and therapists will be able to service more individuals with online discussion forums and video demonstrations. The more people engage in cognitive remediation, the better the outcomes. This is particularly true for receiving a consistent dose of exercise, rather than in longer, once per week sessions typical of traditional psychotherapies. The online component of this program provides patients with the ability to engage in a higher and more consistent rate of exercises and skill development, and we will explore whether the amount and continuity of engagement is associated with larger and broader improvements.
The investigators propose to test whether curcumin nanoparticles will improve behavioral measures and biomarkers of cognition and neuroplasticity in patients with schizophrenia who are already receiving a stable dose of antipsychotic.
Cognitive deficits are known to be a core feature of schizophrenia and seem to become manifest in the prodromal or Ultra-High Risk (UHR) state of psychosis. The cognitive deficits are known to pose a critical barrier to functional recovery. Hence it is of vital importance to find intervention strategies that can alleviate these cognitive deficits and consequently improve daily functioning, and quality of life, as well as the prognosis for UHR-patients. The investigators will examine whether: - Cognitive remediation therapy will be superior to standard treatment in improving cognitive functioning in UHR- patients (null hypothesis: No difference between the two groups). - Cognitive remediation therapy will be superior to standard treatment in improving psychosocial functioning and clinical symptoms in UHR-patients (null hypothesis: No difference between the two groups).
The present study aims to : 1. compare different approaches (high intensity vs. low intensity) to training community providers (those who routinely treat young patients with bipolar disorder, psychosis, or sub-threshold high-risk conditions) on the implementation of family-focused treatment (FFT); 2. assess the cost of FFT training and implementation support; and 3. determine whether these different forms of clinician training are associated with different outcomes over 1 year among patients with early-onset mood and psychotic disorders.
This study is to assess the bioavailability of LY03004 compared to Risperdal Consta as well as the evaluate the safety and tolerability and preliminary efficacy of LY03004 with repeat injections
The goal of this project, which has not changed, is to improve the health and fitness of persons with serious mental illness (SMI) using an innovative model: In SHAPE Lifestyles. Participants are randomly assigned to the In SHAPE program or Health Club Membership and Education only. The three specific aims of this study are to: 1. To compare the treatment groups with respect to improvement in physical fitness outcomes, including: (a) health behaviors (engagement in exercise and diet changes); and (b) indicators of physical fitness. 2. To compare the treatment groups with respect to improvements in mental health outcomes, including negative symptoms, depression, and self-efficacy. 3. To explore differences in the treatment groups with respect to psychosocial functioning, health status, and acute service use, and the effects of selected demographic, clinical, and health behavior variables on primary outcomes.