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Mental Disorders clinical trials

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NCT ID: NCT03881657 Completed - Obesity Clinical Trials

Reverse Colocated Integrated Care Intervention Among Persons With Severe Persistent Mental Illness at US-Mexico Border

Start date: November 24, 2015
Phase: N/A
Study type: Interventional

This study evaluated whether patients with severe and persistent mental illness (SPMI) who received coordinated co-located behavioral health and primary care services were more likely to improve health outcomes after 12 months compared to SPMI patients who receive only behavioral health services from the local mental health authority (LMHA) Tropical Texas Behavioral Health (TTBH).The study employed a randomized control trial (RCT) design where intervention participants receiving integrated behavioral health were compared to control participants receiving the usual care provided within an LMHA for SPMI patients. Patients were placed in each group using a randomized number process. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data was subsequently collected at 6-month and 12-month follow-up points.

NCT ID: NCT03873922 Not yet recruiting - Schizophrenia Clinical Trials

Ketogenic Diet for Psychotic Disorders - A PsyDiet Pilot Study

PsyDiet
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Disturbances in glucose metabolism and glutamate neurotransmission feature in the pathophysiology of psychotic disorders. Ketogenic diet (KD) is a high-fat, low-carbohydrate diet that restricts glucose and forces metabolism of ketones, which serve as alternative energy substrates for the brain. KD is an established treatment for intractable epilepsy. However, we lack the randomized controlled trials (RCT) evidence regarding potential effects of KD on psychotic symptoms in humans. This randomised, controlled pilot study aims to investigate: 1. feasibility of a Modified Ketogenic Diet (MKD) intervention protocol in psychotic inpatients, 2. potential impact of MKD intervention on psychotic symptoms, depressive and anxiety symptoms, and functioning in patients with psychotic symptoms / psychotic disorder. A 6-week randomised KD pilot study will be carried out in psychotic inpatients (aimed n=40) at Kuopio University Hospital, Finland. In the KD group, carbohydrate consumption is limited to 15-20 g/day to activate ketosis. The control group will have their ordinary hospital meals. A number of different assessment will be carried out at time points 0, 1 week, 3 weeks and 6 weeks.

NCT ID: NCT03869177 Recruiting - Psychotic Disorders Clinical Trials

Implementation of Guidelines on Family Involvement During Primary Psychotic Disorders.

IGFIP
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

This study will develop and evaluate a complex intervention to implement guidelines on family involvement for patients with primary psychotic disorders (F20-29 in International Classification of Diseases ICD-10) in the psychiatric outpatient clinic, by using a cluster randomised design. Fifteen Norwegian outpatient clinics participate in the study, and each of them constitutes a single cluster, except for two collaborating clinics who are considered one cluster. Of the fourteen clusters, half will receive implementation support and training immediately, whereas the other half will receive it one and a half year later. The study will assess both service level outcomes, by measuring fidelity scores, and selected outcomes for patients and caregivers, by collecting questionnaires and data from central health registers and patient records. In addition, qualitative interviews will be performed with patients, caregivers and health care personnel. The study will also include an economic analysis and a political economy analysis.

NCT ID: NCT03865485 Recruiting - Clinical trials for Child Mental Disorder

Prevention of Child Mental Health Problems in Southeastern Europe (RISE) - A Factorial Study (Phase 2 of MOST)

RISE
Start date: March 2019
Phase: N/A
Study type: Interventional

The aim of this study is to optimize an adapted version of a parenting program, Parenting for Lifelong Health for Young Children (PLH), to meet the specific needs of families in three low- and middle-income countries in Southeastern Europe (Romania, FYR of Macedonia and Republic of Moldova) using a cluster factorial experimental design to select the most efficacious, cost-effective, and scalable intervention components. This study is the second phase of a three-phase research project (www.rise-plh.eu). The cluster factorial experiment will examine the effectiveness, cost-effectiveness, and implementation of three selected components of the PLH for Children program to inform the selection of the most effective, cost-effective, and implementable components to include in a prevention package prior to testing it in a subsequent RCT. The cluster factorial experiment will be conducted across three Southeastern European country sites. Each site will recruit families with children aged two to nine years who have elevated levels of child behavior problems, including specifically high-risk groups, such as minorities (e.g. Roma families). Program facilitators will be recruited from local agencies and schools. The factorial experimental trial will randomize 16 clusters in each country to one of 8 experimental conditions which consist of any combination of the three components (program length: 5 sessions/10 sessions; engagement booster: high/low; fidelity booster: high supervision/low supervision). The purpose of this factorial experiment is to estimate the main effects of the three intervention components and interactions between the components. At the end of the cluster factorial experiment, we will develop an optimized version of the program by selecting components or component levels that have the highest level of effectiveness as based on effect size (rather than p-values). We will also take into consideration factors regarding cost-effectiveness and implementation outcomes when designing this optimized intervention package.

NCT ID: NCT03863366 Completed - Depression Clinical Trials

Effects of Acute Prucalopride Administration in Healthy Volunteers

Start date: February 7, 2017
Phase: N/A
Study type: Interventional

This study will investigate whether administration of a single dose of the serotonin receptor subtype 4 (5-HT4) partial agonist prucalopride has effects on emotional processing and non-emotional cognition in healthy volunteers, compared to placebo administration. Using an experimental medicine approach, the effects of prucalopride on cognitive biomarkers of antidepressant action will be characterised. In a double-blind design, participants will be randomised to receive a single dose of either prucalopride (1mg) or placebo. All participants will come for a Screening Visit to ensure their suitability for the study. If they meet study criteria, they will be invited to a Research Visit, where they will receive the study medication and wait for two hours while the drug reaches peak levels. After two hours they will be asked to complete a series of computer-based tasks measuring emotional, non-emotional cognitive processing, and reward processing. The primary study hypothesis is that acute prucalopride administration will have positive effects on processing facial expressions of emotion. Secondary hypotheses are that acute prucalopride administration will affect other measures of emotional processing, and non-emotional cognition.

NCT ID: NCT03862209 Recruiting - Schizophrenia Clinical Trials

Community-based Mental Health Care for People With Severe and Enduring Mental Ill Health (RECOVER-E) Croatia

RECOVER-E
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

To contribute to improving the level of functioning and quality of life and mental health outcomes for people with severe and enduring mental ill health (SMI) (schizophrenia, bipolar disorder, depression) by adapting and up scaling the implementation of a community‚Äźbased service delivery model in Croatia.

NCT ID: NCT03857581 Not yet recruiting - Psychosis Clinical Trials

Clozapine Versus Olanzapine as Treatment for Comorbid Psychotic Disorder and Substance Use Disorder

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

The purpose of this trial is to determine if patients with comorbid psychotic disorder and substance use disorder will continue in treatment longer if treated with clozapine than with olanzapine, and will have greater reductions in psychosis and in substance use if treated with clozapine than treated with olanzapine. The specific aims and hypotheses of this trial are: 1. To compare the enduring effectiveness and tolerability of clozapine and olanzapine, as measured by time to all-cause treatment discontinuation, over 12 weeks of follow-up; we hypothesize that patients assigned to clozapine treatment will have significantly longer times to all cause treatment discontinuation, 2. To compare the total psychosis items scores between patients treated with clozapine and patients treated with olanzapine over 12 weeks of follow-up; we hypothesize that patients treated with clozapine will have significantly lower total psychosis items scores than patients treated with olanzapine, and 3. To compare the frequencies of positive urine drug screens and blood alcohol levels (obtained weekly throughout 12 weeks of follow-up) between patients treated with clozapine and patients treated with olanzapine; we hypothesize that patients treated with clozapine will have significantly fewer positive urine drug screens and blood alcohol levels than patients treated with olanzapine.

NCT ID: NCT03855761 Recruiting - Clinical trials for Mental Disorders, Severe

Testing a Novel Community-based Occupational Therapy Model

Start date: February 18, 2019
Phase: N/A
Study type: Interventional

This study will perform a needs assessment within an outpatient mental health unit, deliver an occupational therapy model of care, track patient and organizational outcomes, and provide training to staff to implement the model.

NCT ID: NCT03854045 Enrolling by invitation - Mental Disorder Clinical Trials

Exploratory Study Providing Telepsychiatry in the Home With a Clinician Present

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Telemedicine can expand access to behavioral health services for people who have difficulty traveling to clinics. Travel can be especially challenging for older adults with mobility issues or access to reliable transportation. Assessment in the home can uncover factors impacting patient's physical and behavioral health. The goals of this project to document benefits and barriers to expanding reimbursement for telemedicine to older patient's home as the originating site.

NCT ID: NCT03850184 Not yet recruiting - Physical Activity Clinical Trials

Translation of the "Exercise in Mental Illness Questionnaire (EMIQ)" to German

Start date: April 2019
Phase:
Study type: Observational

The "The Exercise in Mental Illness Questionnaire (EMIQ) - Health Practicioners Version" is a questionnaire designed to assess the prescription behaviour of physical activity as well as related knowledge, barriers and exercise behaviour of mental health professionals. As a lot of research on prescription behaviour is done using unvalidated questionnaires we want to translate this validated questionnaire into German for further use in this research field.