Medication Review in Patients With Schizophrenia and Diabetes
SchizophreniaDiabetes1 moreThis study aims to investigate the potential beneficial effects of a medication review by a clinical pharmacologist on patients with coexisting schizophrenia and diabetes. The study is an intervention study in which an intervention group is assigned to the medication review whereas a control group is not. Both groups are tested using a thorough test battery at baseline and 6 months after inclusion. Furthermore a qualitative data assessment will be undertaken using interviews and surveys in order to show any obstacles in implementing the intervention. This is relevant as medication reviews, performed by clinical pharmacologists as well as pharmacists, are not always implemented by the primary physician.
Brain Biomarker on Inflammation Response
SchizophreniaIn a double-blinded, randomized, parallel controlled design, patients with schizophrenia spectrum disorder will be exposed to a single dose of lipopolysaccharide (LPS) (LPS-patient). Clinical symptoms, blood samples, and brain imaging will be assessed at baseline and after LPS. There will be two comparison groups. Comparison groups include an age- and sex-matched healthy control group also exposed to the same LPS (LPS-control), and an age- and sex-matched sample of patients with schizophrenia on placebo (Placebo-patient). As in Phase I studies, multiple interim analyses are expected so the current design may be modified, which will be communicated during annual reports (21CFR312.30).
The Effect of Progressive Muscle Relaxation on Psychological Symptoms and Mental Well-Being in Patients...
Schizophrenic PsychosesSchizophrenia is a mental illness that progresses with delusions or hallucinations, causes changes in interpersonal communication, thoughts and behaviors, continues with recovery and repetitions, and in which the interpretation of reality is impaired. Drug treatment alone is not sufficient in schizophrenia, and it is known that negative symptoms continue even in patients with a good response to drug treatment. For this reason, complementary therapies, psychosocial approaches and rehabilitation in addition to drug therapy increase the effectiveness of the treatment.
Technology-Assisted Implementation of a Mobile Health Program for Serious Mental Illness
SchizophreniaBipolar Disorder2 moreThe goal of this clinical trial is to learn about how a digital training platform can enhance implementation and effectiveness of a validated mHealth system, called FOCUS, in people with serious mental illness. The main question this research aims to answer is whether patients obtain similar outcomes to previous FOCUS studies when using FOCUS with clinicians trained on a newly developed digital training platform. Participants will be asked to use the FOCUS smartphone application and receive mobile health coaching from clinicians who have been trained using the digital training platform.
Physical Exercise in Patients With Schizophrenia
SchizophreniaPhysical Activity2 moreRandomised clinical trial on a cohort of subjects with a diagnosis of schizophrenia of legal age, of both sexes, recruited in the mental health clinics of the Salamanca University Assistance Complex and who will be randomly distributed into two groups (intervention and control). The main objective of the study is to determine the effect of physical exercise on telomere size in patients diagnosed with schizophrenia. As secondary objectives in this group of patients we will try to: Evaluate the influence of strength training on cognition and negative symptoms of schizophrenia. To quantify the impact of strength training on frailty. To determine the effect of strength training on quality of life. To study the possible correlation between physical parameters (frailty) and telomere length. To establish the importance of polymorphisms in telomerase genes, an enzyme involved in the maintenance of telomere length.
The IM-ZBULLE Study : " Z-track " and " Airlock " Techniques During Intramuscular Injection of Haloperidol...
Schizophrenia; PsychosisIntramuscular injection (IMI) is the process of administering a drug treatment into muscle tissue. The transmission of skills in this care practice is essentially based on the experience of peers. In France, there are no official guidelines for this technical procedure. Haloperidol decanoate is widely used in psychiatry. This long-acting antipsychotic treatment considerably reduces the risk of relapse and hospitalization. It is administered by IMI. This treatment is invasive, painful and risks complications for the patient. Nurses must ensure that the treatment is as painless as possible, and adapt their practice in line with current recommendations. Among the various IMI techniques available, the "Z-track" and the "Airlock" limit leakage into subcutaneous tissues when the needle is withdrawn, by locking the active product into the muscular tissues. According to an exploratory study (n=303), 73% of nurses observe active product leakage after injections, and 89% of nurses are not familiar with either the "Z-track" or "Airlock" techniques. Many foreign studies have been carried out to demonstrate the relevance of these techniques, particularly in terms of pain reduction during treatment, but the results have yet to be confirmed. The investigators hypothesize that the combined use of the "Z-track" and "Airlock" techniques during intramuscular injection of Haloperidol decanoate is more effective in reducing patient pain than usual practice.
Shared Decision Making for Antipsychotic Medications
SchizophreniaSchizoaffective Disorder3 moreThis study aims to provide an evidence-based shared decision making intervention for antipsychotic medications, the Antipsychotic Medication Decision Aid (APM-DA), for individuals experiencing early psychosis and provide, for the first time, an understanding of the shared decision making mechanism of action.
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During...
SchizophreniaNeuronal Plasticity1 moreAerobic endurance training has shown positive effects on symptoms, cognition, daily functioning, and the structure of the hippocampus in patients with schizophrenia. The study investigates genetic and epigenetic influences on neuroplastic changes following three months of endurance training. A control group performs flexibility, strength, and balance training. The main objective is to examine the association between a genetic risk score for schizophrenia and volume increase in the CA4/DG region of the hippocampus. Additional goals include examining changes in synapses, brain structure, function, and metabolism, as well as clinical symptoms and cognitive performance.
Anti-Inflammatory Challenge in Schizophrenia
SchizophreniaThis research project will explore negative symptoms of schizophrenia, such as motivational deficits, by examining the relationship between inflammation and reward-related brain regions. To accomplish this, we will administer a single infusion of either the anti-inflammatory medication infliximab or placebo (n=10 per group) to patients with high inflammation. This study is important because schizophrenia can be a chronic and debilitating neuropsychiatric disorder and negative symptoms are some of the most difficult aspects of schizophrenia associated with worst functional outcomes. These symptoms do not typically respond to antipsychotic therapies, and as such, there are no current medications to treat negative symptoms.
An Open-label Study to Assess the Long-term Safety, Tolerability, Effectiveness, and Durability...
SchizophreniaThis is a Phase 3b, 3-year, open-label, multi-center study in which patients with DSM-5 diagnosis of schizophrenia whose current medication(s) is not well tolerated and/or clinical symptoms are not well controlled will be switched to receive KarXT. The primary objectives of the study are to assess the long-term safety and tolerability of KarXT and assess effectiveness, persistence, and durability of effect of KarXT through the Investigator Assessment Questionnaire (IAQ) and Clinical Global Impression - Severity of Illness (CGI-S) scale in patients with a diagnosis of schizophrenia. The secondary objectives are to further assess the effectiveness using the Clinical Global Impression, Global Improvement (CGI-I), long-term safety and tolerability of KarXT, and evaluation of scores from multiple additional patient scales and assessments throughout the study.