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Psychiatric Disorders clinical trials

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NCT ID: NCT03809897 Withdrawn - Clinical trials for Tobacco Use Cessation

Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders

Start date: January 2019
Phase: Phase 4
Study type: Interventional

Varenicline increases smoking abstinence rates compared to bupropion, nicotine patch or placebo in outpatients with psychiatric disorders. The American Psychiatric Association identifies psychiatric hospitalizations as an ideal opportunity to treat tobacco dependence. However, no previous studies have tested whether varenicline may improve smoking cessation rates compared to nicotine patch in hospitalized patients with mental illness. Additionally, varenicline has shown to be safe for mental health stable outpatients, but safety in psychiatric inpatients is unknown. Multisite open trial controlled study designed to assess varenicline's effectiveness on smoking cessation compared to nicotine patch, in patients who are discharged from a psychiatric unit. Treatment will start during hospitalization and last 12 weeks followed by a non-treatment follow-up phase for 4 weeks. Safety will be assessed by comparing the incidence of adverse events. Participants will be randomized to receive varenicline or nicotine patch during 12 weeks. All participants will receive smoking cessation counseling.

NCT ID: NCT03313154 Completed - Clinical trials for Cognitive Impairment

Impact on QoL and Cognitive Functioning of New Antiviral Therapies in Subjects With Chronic Hepatitis HCV-related

Start date: November 2015
Phase:
Study type: Observational

Chronic hepatitis HCV-related is the most common cause of chronic liver disease in Italy. Patients with chronic hepatitis C present a prevalence of depressive disorders higher than that of the general population; moreover, it has been repeatedly demonstrated the presence of cognitive deficits and poor quality of life. Chronic hepatitis C therapy was based on the combined use of pegylated alpha-interferons (PEG-INF), and ribavirin. Recently, new therapeutic protocols have been introduced, and while some antiviral drugs, including the first-generation ones, were used only in combination with PEG-IFN and ribavirin, the second and third generation antiviral drugs protocols are interferon-free. However, because of the high cost, the access to interferon-free protocols is only for patients with advanced fibrous stages, or with concomitant extra-hepatic HCV-related diseases, or for transplanted patients. Many side effects, such as flu-like symptoms, and psychiatric symptoms (depression, anxiety, irritability, insomnia) are common during antiviral therapy with IFN. However, in patients with chronic hepatitis C, a high lifetime prevalence of major depressive disorder, panic disorder, and brief recurrent depression have been observed, irrespective of IFN treatment and the use of alcohol and narcotics; such associations between mood and anxiety disorders and chronic hepatitis C may reflect a high prevalence of bipolar spectrum disorders. The presence of severe psychopathological symptoms requires the reduction of posology and causes high rates of discontinuation of antiviral therapy. This project represents an innovative psychiatric and neuropsychological screening program for patients with chronic hepatitis C, eligible for antiviral therapy. 1. Primary objectives: 1. to verify the medium-term impact of new antiviral therapies on quality of life, psychological well-being and cognitive function in subjects with chronic hepatitis C; 2. to verify the predictability of specific psychopathological components and specific determinants on compliance with new antiviral therapies. 2. Main secondary objectives: 1. to verify the evidence of association between various psychiatric disorders and cognitive deficits and chronic hepatitis C; 2. to evaluate the relative weight of psychopathological and/or cognitive disorders on the efficacy of antiviral therapy and on quality of life.

NCT ID: NCT03125083 Completed - Clinical trials for Psychiatric Disorders

Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus

RIP-LC
Start date: May 5, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the role of inflammation in the high prevalence of psychiatric disorders in skin-restricted lupus (SRL) patients. SRL is an inflammatory disease. Inflammation can lead to a decrease in the synthesis of neurotransmitters via the activation of the IDO enzyme and to induce the synthesis of neurotoxic molecules (kynurenin pathway). This leads to the development of psychiatric disorders. Investigator therefore want to compare inflammation and neurotransmitter synthesis in SRL patients according to the presence or absence of psychiatric disorders. Investigator expect a decrease in neurotransmitter synthesis and activation of the kynurenin pathway in patients with a psychiatric disorder.

NCT ID: NCT02987426 Completed - Clinical trials for Psychiatric Disorders

Can Brief-mindfulness Interventions Improve Psychiatric Symptoms?

Start date: May 19, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Mindfulness-based interventions have gained increasing popularity in recent years as effective treatment for mental illness. Mindfulness is defined as paying attention in a particular way: on purpose, in the present moment, and non-judgmentally: "Being", rather than "Doing". Such mental states can improve emotional regulation through frontal cortex inhibition of otherwise dysregulated subcortical emotion-related circuits. Formal mindfulness approaches such as mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction, have been highly effective in a broad range of psychiatric disorders. Mindfulness-oriented interventions, are potentially useful in acute psychiatric hospitalizations, since they can be delivered as group therapies and are be both cost-effective and scalable. However, such interventions have rarely been provided to patients during psychiatric hospitalizations, where patients are treated for a variety of psychiatric diagnoses, and may have unpredictable lengths of stay. Additionally, there had been concerns that longer traditional mindfulness based interventions (e.g. 30 minute silent meditation) may exacerbate acute psychosis. However, strong evidence suggests that patients with psychotic symptoms appear to be largely unaffected by shorter interventions. Similarly, MBCT have been helpful to treat other major reasons for hospitalization such as: bipolar disorder, severe anxiety, substance use disorders, and major depressive disorder. Few studies have examined mindfulness-oriented treatments in inpatient settings, including two small studies involving mindfulness groups on an acute psychiatric inpatient ward (n<10) . Another study (n=23) offered inpatients with a diagnosis of major depressive disorder mindfulness-based activities. All studies concluded that mindfulness-oriented approaches in inpatient settings were feasible, although these needed to be brief interventions, given the risks and lack of efficacy of longer MBI (e.g. 40-minute silent meditation) in severe mental illness. A cross-sectional study conducted by our team (n=40) demonstrated that brief group mindfulness-oriented lasting 10 minutes were very well tolerated by 92.5% of psychiatric inpatients. The remaining 7.5% of patients left the session before 10-minutes, but had no symptomatic exacerbations or adverse effects. Moreover, the 50% of patients self- reported improvements in general well-being and mood after a single 10-minute session. Having been recently admitted to the psychiatric inpatient or having a diagnosis of acute psychosis (75% of inpatients) did not affect patients' capacity to tolerate and benefit from the intervention. In this inpatient psychiatric population, we found that mindfulness-oriented interventions that were brief and involved physical movement (e.g. seated Tai Chi) were better enjoyed compared to other interventions. Despite the growing literature in this field, data is needed on the effectiveness and health service implications of brief group mindfulness-oriented interventions in inpatient psychiatry settings. Outcome studies conducted so far cannot be interpreted reliably due to methodological flaws, including inadequate control groups, very small sample sizes (often n<10), and lack of randomization. In Canada, the direct cost of treatment for mental illness is estimated as 42.3 billion. Much of these costs are driven by psychiatric admissions. Thus, if brief mindfulness-oriented interventions are effective at lowering psychiatric symptom severity and shortening psychiatric hospitalizations, this could lead to significant cost-savings.

NCT ID: NCT02857322 Not yet recruiting - Clinical trials for Psychiatric Disorders

Effectiveness Accompaniment Perioperative Patients With Psychiatric Illness on the Lives Perioperative

VEPSY
Start date: January 2017
Phase: N/A
Study type: Interventional

The experimental strategy is to develop a specific device about the anesthetic and surgical acts for a subject with a documented psychiatric condition and to benefit from surgery. This device is based on 3 stages: pre-operative phase, Phase perioperative and postoperative phase. A nurse anesthetist will come into contact with the subject the day before surgery. This contact will be concomitant with the pre-anesthesia visit. She explained about the general organization of the arrival in the operating room. The interview will be a minimum of 15 minutes and beyond if necessary. This will be accompanying this the next day in the operating room in order to optimize its hospitality and installing the block, guide the subject through all the steps before falling asleep. Finally, even accompanying will be present upon awakening the subject in the recovery room.

NCT ID: NCT02665988 Terminated - Chronic Pain Clinical Trials

Adjunctive Transcranial Direct Current Stimulation

tDCS
Start date: January 2016
Phase: N/A
Study type: Interventional

Transcranial direct current stimulation (tDCS) is an investigational device that has not been approved for the treatment of any medical condition by the FDA but is allowed to be used for research purposes. In clinical trials tDCS has been associated with pain relief by decreasing the intensity and duration of chronic pain. tDCS potentially works by stimulating the brain by delivering an extremely low-level electrical current to areas below the forehead - areas associated with chronic pain. It is anticipated that this current will increase brain activity or the likelihood of brain activity in these areas, affecting individual's ability to regulate pain. The purpose of this study is to compare eligible participants in the Pain Management Program at The Menninger Clinic receiving adjunctive real transcranial Direct Current Stimulation (tDCS) versus those receiving sham tDCS in the resolution of chronic pain. The primary objectives are: (1) improving pain tolerance and (2) improving subjective pain experience. Secondary objectives are: (1) improving subjective experience of sleep quality and (2) increasing physical activity.

NCT ID: NCT01989728 Completed - Depression Clinical Trials

Prevalence and Effect of Detecting Common Mental Disorders in Long-term Sickness Absence

PRW
Start date: November 2004
Phase: N/A
Study type: Interventional

The hypothesis was that a large fraction of individuals with common mental disorders were undetected in long-term sickness and that detection of the disorders by screening, a psychiatric diagnostic examination and feedback to the individuals, primary care, and rehabilitation officers improved return to work, improved quality of life and reduced psychological distress.

NCT ID: NCT01823250 Completed - Clinical trials for Substance Use Disorders

Culturally Informed Family Based Treatment of Adolescents: A Randomized Trial

CIFFTA
Start date: January 2011
Phase: Phase 2
Study type: Interventional

This Stage II randomized trial tests Culturally Informed & Flexible Family Based Treatment for Adolescents (CIFFTA) developed as part of a Stage I treatment development effort and yielding promising preliminary findings. Drug use rates are highest among Hispanic middle school youth and to date no treatments have met criteria for "Well Established" in the treatment of substance abuse in Hispanic adolescents. Further treatment for Hispanic youth and families is complicated by the fact that these families often differ from mainstream populations in culture-related values, beliefs and behaviors that can directly impact engagement, retention, and efficacy/effectiveness of drug treatment. Our efforts to develop a more powerful treatment capable of addressing these issues began with a Stage 1 study that led to the development of a multi-component treatment that includes a flexible manual that allows treatment tailoring to the unique characteristics of individual families. CIFFTA integrates innovative culturally-based, individually-based, and family-based components to: 1) reduce maladaptive family processes (e.g., poor parenting practices, family conflict) and increase family protective factors (e.g., strong parent-child attachment), 2) teach adolescents skills to effectively manage interpersonal conflicts and stressors and to increase motivation to change, 3) deliver psycho-educational and culturally congruent material (e.g., modules on immigration stressors) to youth and parents both separately and together, and 4) deliver the intervention using a flexible treatment manual that allows the clinician to tailor the treatment (e.g., by selecting the most relevant psycho-educational modules and themes) to the unique characteristics and needs of the Hispanic family. This Stage II randomized trial randomizes 220 Hispanic adolescents ages 14-17 who meet DSM-IV criteria for Substance Abuse to a 4-month treatment of either CIFFTA or Traditional Family Therapy. The study tests CIFFTA's efficacy in impacting drug use, risky sexual behavior, and other severe behavior problems, and hypothesized mechanisms of change, in a larger and more rigorous Stage II trial. Assessments occur at baseline, 4 months post baseline (end of treatment), 10 months post baseline and 16 months post baseline. Should this line of research continue to be successful, it has the potential to contribute to the field a highly innovative and efficacious treatment for Hispanic drug abusing adolescents, a better understanding of mechanisms of treatment efficacy, and also a framework for future flexible and tailored treatments that can be used to better address the unique needs of other special populations.

NCT ID: NCT01786733 Completed - Depressive Symptoms Clinical Trials

Behavioral Activation - From Inpatient to Outpatient Services

Start date: March 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effectiveness of Behavioral Activation and Supportive Therapy added to the standard acute psychiatric inpatient care. Therapy starts during inpatient care and can continue in an outpatient facility if the patients are discharged before 12 sessions has been completed.

NCT ID: NCT01289080 Completed - Schizophrenia Clinical Trials

Trial Evaluating OPC-34712 in Subjects With Normal Renal Function and Renally Impaired Subjects

Start date: January 2011
Phase: Phase 1
Study type: Interventional

This trial is an open-label, multi-center, parallel-arm, single-dose trial in 2 groups: 1 group of subjects with normal renal function and 1 group of severely renally impaired subjects.