Withania Somnifera: an Immunomodulator and Anti-inflammatory Agent for Schizophrenia
SchizophreniaSchizoaffective DisorderWithania somnifera (WSE; Ashwagandha in Ayurveda) extracts have been used as an adaptogen or to build resistance to stress or diseases in indigenous medical systems in India for centuries. Modern scientific data for WSE indicate several bioactive molecules (withanolides, withanosides, indosides, withaferin-A, others) with significant immunomodulatory, anti-inflammatory and stress reducing properties. This study will examine whether a standardized extract of Withania Somnifera (WSE; Sensoril®) will improve total, positive, negative symptoms, and stress in patients with schizophrenia. The study will examine whether WSE reduces PANSS positive and negative symptoms and stress scores in subjects, and whether these improvements are mediated by changes in inflammatory immune indices. An additional aim will determine if patients receiving WSE will have fewer adjustments to their psychotropic medications that those assigned to placebo. The study will examine whether WSE will re-balance Th1/Th2 ratios (cytokine measures) and mediate a reduction of elevated hs-CRP levels. It is hypothesized that those subjects whose Th1/Th2 ratios normalize will likely have a greater magnitude of clinical improvement versus those subjects whose immune ratios remain unbalanced. The proposal is a 12-week, double-blind, placebo-controlled RCT of WSE added to antipsychotic medications in approximately 60 or more patients with schizophrenia with an exacerbation of symptoms. If efficacy is affirmed, this low cost extract could be studied further, and used quite readily across low, middle and high income countries.
Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue
ObesityMetabolic Syndrome X2 moreTo examine if 3 months of treatment with a GLP-1 (glucagon-like-peptide-1) analogue can induce weight loss in obese, non-diabetic patients with a diagnosis within the schizophrenic spectrum. The investigators will also examine possible associations between GLP-1 treatment and peripheral metabolic parameters such as change in body fat and HbA1c. Moreover, the GLP-1 analogue treatment will be associated with the effects/changes on cognition and subjective quality of life. Possible cerebral effects (pro-cognitive) of the GLP-1 analogue treatment will associated and correlated with changes in the brain, functional magnetic resonance imaging (fMRI).
Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia
SchizophreniaSchizophreniform Disorder1 moreThe purpose of this study is to evaluate the efficacy and safety of A-prexa compared to Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective disorder.
Prevention of Relapse With Injectable Paliperidone Palmitate Versus Oral Antipsychotics
SchizophreniaThe purpose of this study is to assess the efficacy (how well the drug works; primarily through the time to relapse) of long-acting injectable paliperidone palmitate compared to treatment as usual with orally administered antipsychotics in monotherapy over 24 months in the treatment of recently diagnosed (1-5 years since diagnosis) schizophrenia.
Safety and Efficacy of Cariprazine in Patients With Schizophrenia
SchizophreniaThe objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
Safety and Efficacy Study for Cognitive Deficits in Adult Subjects With Schizophrenia
Cognitive Deficits in SchizophreniaThis is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia.
Compensatory Strategies Applied to Cognitive Impairment in Schizophrenia
SchizophreniaThe purpose of this study is to determine whether Cognitive Adaptation Training are effective in comparison with conventional treatment, focusing on social functions, symptoms, relapse, re-hospitalisation, and quality of life in outpatients with schizophrenia.
Artemisinin to Reduce The Symptoms of Schizophrenia
SchizophreniaSchizoaffective DisorderThe investigators intend to explore the hypothesis that symptoms of schizophrenia may be reduced by the antimalarial compound artemisinin when used in addition to standard antipsychotic medications.
Efficacy Study on Cognitive Functions in Schizophrenic Patients
SchizophreniaPrimary objectives To compare neurocognitive effects of amisulpride with those of risperidone in patients with chronic schizophrenia, as assessed by the general cognitive index, a measure of overall cognitive functioning in schizophrenia Secondary objectives Secondary analyses will be conducted to determine how the two atypical agents' neurocognitive effects compare with regard to their profile of therapeutic action (based on individual cognitive domain scores in seven cognitive domains, including speed of processing, attention/vigilance, working memory, verbal learning and memory, visual learning and memory, reasoning and problem solving and social cognition); Investigate whether amisulpride elicits more improvement on negative symptoms compared to risperidone treatment, as measured by the total score on the Scale of the Assessment of Negative Symptoms (SANS) 8 and by the Negative Symptom Subscale of the Positive and Negative Symptom Scale (PANSS); Assess whether amisulpride improves overall functioning and individual domains of psychotic symptoms compared to risperidone as measured by the Clinical Global Impression (CGI), and the total and positive and general psychopathology subscale scores of PANSS and by the individual domains of SANS, respectively; Evaluate the safety and tolerability of amisulpride and risperidone based on the study completion rates, and frequency of abnormal laboratory values, prolactin serum concentrations and on the Simpson Angus Scale for Extrapyramidal Symptoms (SAS) 10 and the Abnormal Involuntary Movement Scale (AIMS).
Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol Intramuscular...
SchizophreniaThis is a multi-centre, open, randomized, haloperidol-referenced, 47 days two treatment sessions, parallel-group study. After screening period, eligible subjects will be entered 5 days treatment session I to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation, then will be followed by 6 additional weeks treatment session II for exploring the effect of medicine switching from IM injection to oral.