Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease...
Parkinson Disease PsychosisThis clinical trial will test whether AGB101 (low-dose levetiracetam, 220 mg, extended release tablet) can improve symptoms of psychosis in Parkinson's disease. Participants will be asked to complete up to 5 in-person study visits over approximately 20 weeks. Participants will receive both AGB101 and a placebo to take once a day for 6 weeks, with a 4-week washout in between. Participation will also involve physical/neurological exams, questionnaires, paper and pencil tests, providing blood and urine samples, and completing two MRI exams.
A Comprehensive Third-generation Intervention for People With Psychosis and Post-traumatic Stress...
TraumaPsychological1 moreExisting data suggest that both trauma and Post-Traumatic Stress Disorder (PTSD) are very common among individuals with psychosis. The presence of PTSD symptoms in psychosis is associated with worse clinical outcomes and poorer social functioning. However, PTSD is a poorly attended and poorly studied condition among this population. Research to date indicates that trauma-focused treatments are safe and effective for PTSD, even when psychotic comorbidity is present. Recent systematic reviews of psychological interventions for trauma in psychosis found that are effective in reducing trauma symptoms, suggesting that they should be implemented in front-line services. Nonetheless, larger confirmative trials are required to form robust conclusions.The aim of this project is to examine the efficacy of comprehensive third-generation protocol for people with comorbid trauma and psychosis.
Acceptance and Commitment Therapy-based Lifestyle Counselling Programme for Early Psychosis on Physical...
Schizophrenia Spectrum and Other Psychotic DisordersThis pilot randomized controlled trial aims to determine the feasibility, acceptability and preliminary effects of an Acceptance and Commitment Therapy-based Lifestyle Counselling Programme (ACT-LCP) on the physical and psychosocial health outcomes of patients with early psychosis over a 12-week follow-up.
D-serine AudRem: R33 Phase
SchizophreniaSchizo Affective DisorderSchizophrenia is a major public health problem associated with cognitive deficits, such as short and long term memory, executive functioning, attention and speed of processing that are amongst the strongest predictors of impaired functional outcome. In addition, schizophrenia patients show reduced "plasticity", defined as reduced learning. D-serine is a naturally occurring activator of the N-methyl-d-aspartate-type glutamate receptors (NMDAR) in the brain, and this project will assess the D-serine treatment over 16 weeks of a program designed to measure auditory plasticity.
Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric...
Mood DisordersAnxiety Disorders1 moreA 24-week, patient- and rater-blinded, two-arm, parallel-group controlled, and multi-centre randomized clinical trial (RCT) to establish the benefits of pharmacogenetics-informed pharmacotherapy versus dosing as usual (DAU) in psychiatric patients suffering from mood, anxiety, or psychotic disorders.
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder...
SchizophreniaPsychotic Disorders10 moreThis is a randomized, single-dose, open-label, parallel-group study. Patients will undergo the screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 80 eligible patients will be randomized in a 1:1:1:1 ratio to 1 of 4 treatment groups.
Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms...
SchizophreniaSchizoaffective Disorder3 moreTo test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.
Remediation of Visual Perceptual Impairments in People With Schizophrenia
SchizophreniaSchizoaffective DisorderThe purpose of this study is to evaluate the effectiveness of a visual remediation intervention for people with schizophrenia. The intervention targets two visual functions that much research has shown are impaired in many people with the disorder, namely contrast sensitivity and perceptual organization. The first phase of the study will test the effects of interventions targeting each of these processes, as well as the effects of a combined package. A control condition of higher-level cognitive remediation is included as a fourth condition. The second phase of the study will evaluate the effectiveness of the most effective intervention from the first phase, but in a new and larger sample of individuals. Outcome measures include multiple aspects of visual functioning, as well as visual cognition and overall community functioning.
Siltuximab in Schizophrenia
SchizophreniaPsychotic DisordersThis study is a Phase 1 clinical trial to determine the safety, tolerability, and efficacy of Siltuximab (Sylvant) as an adjunct to antipsychotic medications in stable outpatients with schizophrenia. Siltuximab (structural formula C6450H9932N1688O2016S50) is a recombinant chimeric (human-murine) anti-human interleukin-6 (IL-6) monoclonal antibody. Siltuximab is formulated as a concentrate for solution for infusion, and will be administered by intravenous infusion. The investigators propose a 9-week randomized controlled trial of siltuximab, given in adjunct to antipsychotics, in N=30 stable outpatients with schizophrenia or schizoaffective disorder and evidence of increased inflammation in the peripheral blood (high-sensitivity C-reactive protein [hsCRP] >0.5 mg/dL). The investigators hypothesize that adjunctive treatment with siltuximab will be associated with significant improvement in cognition compared to placebo in patients with schizophrenia, baseline IL-6 levels are higher in siltuximab-treated responders versus non-responders, and there will be greater decreases in hsCRP from baseline to week 6 in siltuximab-treated versus placebo-treated responders, with response defined as ≥0.5 SD improvement in cognition. Siltuximab is administered as an intravenous infusion every 3 weeks. Following a screening evaluation, participants will receive three infusions of siltuximab, one at baseline, another at week 3 of the study, and another at week 6. The investigators will measure changes in cognitive function and symptoms over a 9-week period. Complementing previous positive clinical trials of non-steroidal anti-inflammatory drugs, this would be a "proof-of-concept" study that targeting specific cytokines is a viable treatment for schizophrenia. Interleukin 6 and its receptor were discovered and cloned at Osaka University, Japan, by Tadamitsu Kishimoto in the 1980s. Janssen Pharmaceuticals, Inc. began the clinical development of siltuximab for the treatment of multicentric Castleman's disease, a rare blood disorder. Other clinical studies with siltuximab have been conduced for patients with B-cell non-Hodgkin's lymphoma, multiple myeloma, and ovarian cancer. In April 2014,siltuxiumab was approved by the U.S. Food and Drug Administration (US FDA) as Sylvant for human immunodeficiency virus (HIV)-negative and human herpesvirus-8 (HHV-8)-negative multicentric Castleman's disease.
Integrated Care in Psychotic Disorders With Severe Mental Illness
SchizophreniaSchizophreniform Disorder5 moreThe study examine the effectiveness of an integrated care program including therapeutic assertive community treatment (ACT) for people with psychotic disorders fulfilling severe and persistent mental illness (SPMI, ACCESS-II study).