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Schizophrenia clinical trials

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NCT ID: NCT05778591 Not yet recruiting - Schizophrenia Clinical Trials

Low-dose Buprenorphine as a Modulator of Social Motivation in Schizophrenia

Start date: April 1, 2023
Phase: Phase 2
Study type: Interventional

Low social motivation is a significant symptom of schizophrenia and is a major cause of disability and suffering for many patients struggling with the illness. Social motivation refers to the drive to participate in or abstain from social activities. Many patients with schizophrenia evidence both decreased drive to seek positive social input (approach motivation) and heightened drive to avoid negative social input (avoidance motivation) compared to individuals without the illness. Despite the enormous burden of these deficits on patients, there are no medications that effectively treat impaired social motivation. Buprenorphine is an unusual drug that is used to treat opioid use disorder at higher doses and more recently, to treat depression and suicidality at lower doses. It is a unique opioid medication that has a compound action that gives it the potential to improve social motivation both by boosting approach motivation and by reducing avoidance motivation. The effects of low doses of buprenorphine have previously. been studied in healthy volunteers, showing that the drug enhances social motivation. These results in nonclinical volunteers suggest that buprenorphine may be a promising treatment for deficits in social motivation seen in some patients with schizophrenia. However, no previous studies have investigated the effects of buprenorphine on social motivation in this population. Here the effects of a low dose of buprenorphine (0.15mg) on social motivation in patients with schizophrenia (N=40) will be assessed. In this double-blind, cross-over, placebo-controlled study, participants will attend a 2-hour preparatory session and two 6-hour laboratory sessions, at which they will receive either placebo or buprenorphine. During expected peak drug effect they will complete validated tasks assessing social motivation. It is expected that buprenorphine will increase approach motivation and decrease avoidance motivation as measured by an attention bias task. The results of this study will lay the foundation for the clinical use of buprenorphine as the first medication to treat social deficits in schizophrenia.

NCT ID: NCT05770375 Not yet recruiting - Schizophrenia Clinical Trials

Tolerability of MDMA in Schizophrenia

TMS
Start date: March 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Impaired social motivation, or "asociality," is a negative symptom of schizophrenia (SCZ) and a cause of significant functional impairment in the illness. Whereas many symptoms of schizophrenia can be treated with antipsychotic medications, deficits in social motivation persist, leading to significant social disability in patients. There is currently no effective treatment for this symptom of the illness. One promising and unexplored avenue to enhance social motivation in schizophrenia is ± 3,4-methylenedioxymethamphetamine (MDMA). MDMA is a psychostimulant that shares some pharmacological properties with amphetamines, but in addition, has pronounced pro-social effects, increasing the motivation to engage socially. In healthy volunteers, it produces feelings of empathy and closeness with others and increases attention to positive social cues, perhaps partly through its effects on the social bonding hormone, oxytocin. MDMA has shown promise in other psychiatric conditions such as PTSD. Thus, MDMA could offer a unique therapeutic benefit in patients with SCZ who suffer from impaired social motivation. The investigators plan to take the first step in testing MDMA as a treatment for these social deficits by testing the tolerability of the drug in patients with SCZ. This will be an open-label, ascending-dose, within-subject trial in which participants will receive 40mg, 80mg, or 120mg of MDMA. The doses will be administered in ascending order, but doses will be stopped if subjects experience moderate or greater psychotic symptoms at 24 hours. This trial will assess the tolerability of the drug in this population and guide in the selection of a maximum well-tolerated dose for future studies. The primary tolerability measure will be clinician-rated psychotic symptoms (disorganized speech, delusions, hallucinations) collected at 24 hours after MDMA administration. The results of this project will lay the foundation for further investigations of MDMA and other psychoactive compounds as a treatment for debilitating and difficult-to-treat social deficits in schizophrenia. Future studies will examine interactions between the effects of psychoactive compounds and nonpharmacologic psychosocial interventions targeting social symptoms.

NCT ID: NCT05766540 Not yet recruiting - Clinical trials for Difference in the Change in Cardiovascular Risk in Treatment Resistant Schizophrenia

Add-on Aripiprazole on Cardiometabolic Profile in Treatment Resistant Schizophrenia: RCT

Start date: April 20, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial participant population is to evaluate the effect of add on Aripiprazole in reducing the metabolic parameters in patients of TRS on Clozapine with metabolic syndrome. The cardiovascular risk would be measured by calculating the change in QRISK3(QRISK3 is an algorithm tool used to calculate cardiovascular risk. The software calculates the risk score using various parameters. It is a name not an abbreviation.) score and the metabolic parameters by change in Low density lipoprotein(LDL)/High-density lipoprotein(HDL) ratio, High sensitive C Reactive Protein (hs CRP), Insulin resistance (HOMA IR) and fasting plasma glucose level. The main question is to find out the change in cardiovascular risk score between the study groups in TRS on Clozapine with metabolic syndrome. It aims to answer the change in cardiovascular risk in terms of change in QRISK 3 score. - Participants will be assessed for cardiovascular risk using QRISK 3 and entering the entering information like age, height, BMI, weight, Lipid profile, past history of angina, Chronic Kidney Disease (CKD), Migraine etc in the QRISK 3 algorithm. - Subsequently they will be assessed using rating scales like Positive and negative symptom scale (PANSS) and Clinical Global Improvement (CGI) for positive and negative symptoms and clinical global improvement respectively. - They will be randomized into 2 groups and one group will receive treatment as usual while the other group will receive Aripiprazole 10 mg/day along with treatment as usual. - They will be reassessed at 3 time points like baseline, at 3 months and 6 months. - Blood sample will be collected for hs CRP, lipid profile, Fasting Blood Sugar (FBS) at the baseline and after 6 months. Researchers will compare both the groups to see if augmentation with Aripiprazole will reduce the metabolic risk or not.

NCT ID: NCT05766007 Not yet recruiting - Schizophrenia Clinical Trials

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

LAMP
Start date: March 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about how long-acting, injectable mental health 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: NCT05764148 Recruiting - Clinical trials for Negative Symptoms in Schizophrenia

Effectiveness of Behavioral Activation Treatment for Schizophrenia

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to implement a behavior activation remote program for negative symptoms of schizophrenia and to verify whether the behavior activation remote program for negative symptoms of schizophrenia has effects on negative symptoms, cognitive function, and social function of schizophrenia.

NCT ID: NCT05763966 Not yet recruiting - Clinical trials for Schizophrenia; Psychosis

Uppsala Psychosis Cohort

UPC
Start date: March 15, 2023
Phase:
Study type: Observational

A multimodal longitudinal study in early stage psychosis patients and individuals at high risk for psychosis. Healthy controls are included for baseline comparisons. The aim is to investigate disease mechanisms of psychotic disorders, specifically focusing on the synaptic pruning hypothesis.

NCT ID: NCT05759091 Completed - Nurse's Role Clinical Trials

Effect of Applying Cognitive Defusion Techniques on Mindful Awareness, Cognitive Fusion and Believability of Delusions Among Clients With Schizophrenia

Start date: September 10, 2022
Phase: N/A
Study type: Interventional

Schizophrenia causes hallucinations, delusions, and disorganized thinking, resulting in decreased functioning and lifelong therapy.Delusion believability is the degree of belief in the truth of one's subjective experiences as representations of reality. It was unpleasant, typically accompanied by a suspicious, strange tension. Delusional belief is seen as a means of resolving tension and conflict in cognition and experience. Previous studies have shown that cognitive defusion strategies help people become more aware of their surroundings, accept their thoughts and feelings, and become more psychologically adjustable. defusion is crucial in reducing medication-resistant psychotic symptoms such delusions in schizophrenia patients. Therefore, this study aimed to investigate the effects of cognitive defusion techniques on psychological flexibility, mindful awareness, cognitive fusion, and believability of delusions among clients with schizophrenia. Research Hypothesizes - Clients who participated in cognitive defusion techniques had more psychological flexibility and mindful awareness than the control group. - Clients who participated in cognitive defusion techniques had less cognitive fusion and delusional believability than the control group.

NCT ID: NCT05756855 Not yet recruiting - Schizophrenia Clinical Trials

Young Adults With Violent Behavior During Early Psychosis

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

This study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis.

NCT ID: NCT05748990 Not yet recruiting - Healthy Clinical Trials

Does Abnormal Insulin Action in the Brain Underlie Cognitive and Metabolic Dysfunction in Schizophrenia

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Cognitive impairment (such as challenges in thinking and memory) is a core aspect of schizophrenia (SCZ), contributing to disability and poor functional outcomes. Additionally, almost half of the patients with SCZ are obese, the prevalence of type 2 diabetes is 3-6 times higher, and life expectancy is lower by 15-20 years compared to the general population. This is relevant as metabolic syndrome and diabetes are both associated with worse cognition among SCZ patients. Recent work studying the relationships between metabolic health and cognition has encouraged a new way of thinking about SCZ as both a metabolic and cognitive disorder. Brain insulin is involved in several processes relevant to SCZ, and abnormal brain insulin action may help explain both cognitive and metabolic abnormalities in patients with SCZ, but this has not been examined previously. Glucose uptake in several brain regions relevant to SCZ has been shown to be partially dependent on insulin. Therefore, in this study, the researchers will measure glucose uptake in the brain using an 18F-fluorodeoxyglucose ([18F]-FDG) positron emission tomography (PET) scan after an intranasal insulin stimulus, and will compare this measure between patients with SCZ and healthy controls.

NCT ID: NCT05746494 Recruiting - Schizophrenia Clinical Trials

The Efficacy of Neural Stimulation in Individuals With Schizophrenia

Start date: November 21, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to understand the relationship between psychotic symptoms and social functioning in individuals with schizophrenia spectrum disorders. Our goal is to determine whether stimulating the brain using transcranial Direct Current Stimulation (tDCS) can improve symptoms and daily functioning.