View clinical trials related to Schizophrenia.
Filter by:The CLOZAPINE study is designed as a multisite study across 5 sites and is a clinical trial, involving human participants who are prospectively assigned to an intervention. The study will utilize a stringent randomized, double-blinded, parallel group clinical trial design. B2 group will serve as psychosis control with risperidone as medication control. The study is designed to evaluate effect of clozapine on the B1 participants, and the effect that will be evaluated is a biomedical outcome. The study sample will be comprised of individuals with psychosis, including 1) schizophrenia, 2) schizoaffective disorder and 3) psychotic bipolar I disorder. The investigators plan to initially screen and recruit n=524 (from both the existing B-SNIP library and newly-identified psychosis cases, ~50% each) in order to enroll n=320 (B1 and B2) into the RCT.
The purpose of this study is to evaluate the long-term safety and tolerability of cariprazine in the treatment of pediatric participants with schizophrenia, bipolar I disorder, or autism spectrum disorder (ASD) and to establish the benefit-risk profile of long-term treatment in this population.
Auditory hallucinations (AH) are associated with distress and reduced functioning. Psychological interventions show some promising effects on psychopathology but have been less successful in reducing AH related distress, which patients report to be a priority. Research suggests that distress is associated with the hearer relating to AH in a passive and subordinate manner. A novel approach thus teaches assertive responses to AH through the use of experiential role-plays. A single centre pilot study in the United Kingdom evidenced a large effect of this approach on AH distress but independent multicentre studies are required to ascertain effectiveness across different settings. The planned feasibility trial aims to estimate the expected effect for a subsequent fully powered prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial set up to demonstrate that adding a Relating Module (RM) to Treatment as Usual (TAU) is superior to TAU alone. Feasibility questions relate to patient recruitment, therapist training and therapy monitoring in different types of psychological and psychiatric outpatient facilities.
The primary objectives of the study are to characterize the pharmacokinetic (PK) profiles of paliperidone in LY03010 P1 and P2 following a single IM injection in schizophrenia patients and to compare the PK of LY03010 P1 and P2 with that of INVEGA SUSTENNA® following a single IM injection of 156 mg dosage level.
Lyndra is developing an oral, extended release (ER) formulation of risperidone (LYN-005) presented in a capsule dosage form with the intent of reducing the frequency of dosing orally-administered medications to once weekly or less and thereby improving the management of schizophrenia. Study LYN-005-C-004 will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose administration of the ER formulation at two dose levels of LYN-005 relative to IR risperidone.
The diagnostic announcement of a chronic disorder is an essential step in the patient's care. Recommendations specify the importance of including caregivers at the time of the announcement. In practice, caregivers are not systematically associated with the announcement of the diagnosis of schizophrenia, while the daily support of patients is provided in 75% of cases by the family. This support can lead to the exhaustion of caregivers and have repercussions on their sick loved one. This study will qualitatively describe and explore the experience of the diagnostic announcement in relatives of patients with schizophrenia. Specifically, the investigators will explore the history before the diagnosis is announced, the conditions of the announcement and the experiences of relatives as well as the impact at the personal and family-levels. This study will also explore the expectations of caregivers and avenues for reflection for announcement of schizophrenia diagnosis. The number of subjects to be included in this study is therefore set at 30. A preselection of each potential participant will be carried out by phone or in person to ensure the presence of inclusion criteria and the absence of non-inclusion criteria. The patients will also be provided with oral information about the study to allow sufficient time to reflect before inclusion. Then, the selection-inclusion-interview visit will take place visually in an intra-hospital or extra-hospital consultation structure of the Center Hospitalier Alpes-Isère. This visit will be unique and will consist of the entire protocol. It will be both a selection, inclusion and interview visit. Once the results have been analyzed, this study will provide a better understanding of the experiences of relatives of patients when the diagnosis of schizophrenia is announced, the impact of this announcement on caregivers and family relationships and the expectations of caregivers regarding this announcement. In the long term, the data collected will be add value in developing medical recommendations on consultation to announce the diagnosis of schizophrenia to relatives of patients, in order to best meet the expectations of relatives and to minimize as much as possible the harmful impact that can have such announcement.
The purpose of this study is to test whether administration of levetiracetam (LEV), a commonly used anti-epileptic that alters neurotransmitter release, can reduce hippocampal hyperactivity in people with psychotic disorders. Specifically, the investigators will utilize two functional magnetic resonance imaging (MRI) techniques: 1) blood-oxygen-level-dependent (BOLD) contrast will assess activity with a visual scene processing task that engages the anterior hippocampus and 2) arterial spin labeling (ASL) will assess baseline activity. Previous studies in people with psychotic disorders have shown that the hippocampus is hyperactive and more activity correlates with worsening of clinical symptoms. Therefore, the aim of this study is to use an intervention to further understand the underlying mechanisms of the hippocampus in psychosis.
The primary aim of this study is to provide confirmation that Cognitive Remediation (CR) for schizophrenia, when personalized based on pre-treatment assessment of early auditory processing ability, facilitates improved cognitive and functional outcomes. Additional aims of this study address the mechanisms of treatment effect. The study uses a repeated-measures randomized trial design. Enrollment will be by invitation, open to individuals receiving services at select community behavioral health facilities where CR is offered. Clients who are eligible for the service, who agree to participate in research and who meet inclusion/exclusion criteria will be assessed on outcome measures and categorized via performance on the Tone Matching (TM) test, as EAP impaired (EAP-) or EAP intact (EAP+). Subsequently, EAP- and EAP+ subgroups will be randomized to either (1) Brain Basics (BB; n = 100), an EAP-enhanced CR approach or (2) Brain Training (BT; n = 100), a routine CR approach. Participants will be invited to participate in a second pre-treatment assessment to measure electrophysiologic responses to auditory stimuli. All participants will be scheduled to repeat outcome measure assessments after treatment and after a follow-up period. The EAP- group receiving BB will be invited to repeat electrophysiological paradigms post-treatment to investigate mechanisms of change related to the CR intervention. Verbal learning will be the primary outcome with functional capacity the secondary outcome. EEG is exploratory and will examine neurophysiologic markers of need for and response to EAP training.
The purpose of this research is to examine effects of movement training with the aid of rhythmic auditory stimulation (RAS) on reducing severity of dyskinesia and bradykinesia in at-risk individuals and schizophrenia patients. The investigators hypothesize that training with the aid of RAS reduced severity of bradykinesia and dyskinesia in at-risk individuals as well as in schizophrenia patients.
The aim of this study is to assess the efficacy of a short term compensatory cognitive group intervention - the Compensatory Cognitive Training (CCT) among people with severe mental illnesses, receiving ambulatory treatment