Efficacy and Safety Study of Combination of Ginkgo Extract and Ginseng Extract(YY-162)in Children...
Mental DisordersThis study will evaluate clinical efficacy and safety of treatment with YY-162 in children with ADHD
Yoga and Aerobic Exercise in Psychosis
Psychotic DisorderThe current study aims to evaluate the impacts of yoga and aerobic exercise on neuro-cognitive function, symptoms and brain changes in early psychosis. A total of 120 female subjects who aging from 18-55 years old, and diagnosed with psychotic disorders within the past 5 years, will be randomized into 3 groups: 1) yoga therapy, 2) aerobic exercise, and 3) waitlist group as the control. All groups will try to be kept consistent with their medication with no more than 25% change in their entry level dosage for at least six weeks. The primary outcomes of the present study will be neuro-cognitive changes; the secondary outcomes will be changes of brain structure and function.
A Large Pragmatic Cluster Randomized Controlled Trial of a Multi-element Psychosocial Intervention...
PsychosisMulti-element interventions for first-episode psychosis (FEP) are promising but have mostly been conducted on non epidemiologically representative samples in experimental settings, raising the risk thereby of underestimating the complexities involved in treating onset psychosis in "real world" services. The PIANO Trial (Psychosis early Intervention and Assessment of Needs and Outcome) is part of a more broad-based research program (Genetics, Endophenotype and Treatment: Understanding early Psychosis - GET UP) and aims to: 1) test, at 9 months, the effectiveness, as compared to treatment as usual (TAU) of multi-component psychosocial intervention on a large epidemiologically-based cohort of FEP patients and their family members recruited from a 10 million inhabitant catchment area; 2) identify barriers that may hinder its feasibility and patient/family conditions that can render this type of treatment ineffective or inappropriate; 3) identify clinical, psychological, and environmental and service predictors of treatment effectiveness in FEP. Study participants will be recruited from Community Mental Health Centers (CMHCs) operating for the Italian National Health Service and located in several Northern and Central Regions of Italy. The GET UP PIANO Trial has a pragmatic cluster randomized controlled design, which is considered the gold standard approach for trials that evaluate complex interventions implemented at the institutional level, with the aim of improving health. The assignment units (clusters) are the CMHCs, and the units of observation and analysis are the Centers' patients and their family members. Patients in the experimental group will receive TAU plus: (a) Cognitive-Behavioural Therapy (CBT) sessions, (b) psycho-educational sessions for family members, and c) a case manager, to serve as the patient's referent. Patient enrollment will take place over a 1 year interval, after a 3 month-long piloting. The fidelity of the experimental interventions and the characteristics of TAU will be regularly monitored. Several psychopathological, psychological, functioning and service use variables will be assessed at baseline and 9 month follow-up by independent evaluators. Assuming an expected incidence rate of 17/100.000 per year for functional psychoses (as previously estimated in Italy), the investigators expect to recruit about 800 patients, and 600 relatives. Assuming an attrition rate of about 50%, the size of the trial would detect at 9 months a difference in terms of primary outcome from 25% for the TAU arm to 10% for the intervention arm, with a power of 80%.
Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects...
Smoking CessationThis study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).
Escitalopram Treatment for BPSD in Alzheimer's Disease in Comparison to Risperidone
AgitationPsychosis1 moreBehavioral and psychological symptoms of dementia (BPSD) are among the most distressing manifestations of dementia. Pharmacotherapy is frequently used and especially in institutional settings. Current guidelines recommend the use of second-generation antipsychotics (SGAs). Nonetheless, there are concerns regarding both their safety and effectiveness in patients with dementia. Inconclusive evidence support the use of other psychoactive agents such as SSRI antidepressants or cognitive enhancers. In two published studies citalopram was as efficacious as, but better tolerated than perphenazine or risperidone in patients with BPSD. Thus, with proven efficacy and a beneficial safety profile the evaluation of the use of escitalopram for BPSD is warranted.
Assessing the Effectiveness of Acceptance and Commitment Therapy for Distress Following Psychosis...
PsychosisSchizophrenia2 moreThis research investigates a new talking therapy aimed at helping people to come to terms with the experience of psychosis. The new therapy is called Acceptance and Commitment Therapy for psychosis (PACT). PACT aims to help people: Develop a sense of "mindfulness." Mindfulness allows you to be fully aware of your here-and-now experience, with an attitude of openness and curiosity. It is hoped that this will help reduce the impact of painful thoughts and feelings. Take effective action that is conscious and deliberate, rather than impulsive. It is hoped that this will allow people to be motivated, guided, and inspired by the things that they value in life. It is hoped that PACT will help to reduce the level of distress that individuals diagnosed with psychosis have been experiencing and help them to stay well in the future.
A Study of the Effectiveness and Safety of Long-acting Injectable Risperidone Versus Placebo in...
SchizophreniaPsychotic DisordersThe purpose of the study is to compare the effectiveness and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) versus placebo for the treatment of the symptoms of schizophrenia over a 12-week period.
Combination Of PAXIL Tablet And Benzodiazepines
Mental DisordersThis study was designed to assess the efficacy and safety of combination therapy of PAXIL and benzodiazepine anxiolytics. PAXIL Tablet will be administered to patients with depression or depressive episodes who have received Benzodiazepines for at least 4 weeks, and changes in the symptoms of depression will be evaluated by use of the rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D).
A Study of the Safety and Effectiveness of Risperidone for the Treatment of Conduct Disorder and...
Conduct DisorderOppositional Defiant Disorder1 moreThe purpose of the study is to assess the safety and effectiveness of oral risperidone (an antipsychotic medication) in the treatment of conduct disorder and other disruptive behavior disorders in children ages 5 to 12 with mild, moderate, or borderline mental retardation.
A Comparative Study of New Medications for Psychosis in Adolescents
Psychotic DisordersSchizophrenia2 moreThe overall goal of this study is to determine the efficacy and tolerability of three atypical antipsychotic medications (risperidone, olanzapine, and quetiapine) in the treatment of adolescents with psychosis. It is hypothesized that the three medications will be equally effective in reducing the symptoms of psychosis.