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NCT ID: NCT02481895 Completed - Bipolar Disorder Clinical Trials

Efficacy of an Innovative E-neurocognitive Module for Bipolar Disorder

Start date: January 2014
Phase: N/A
Study type: Interventional

Between 40% and 60% bipolar patients experience neurocognitive impairment not only during acute mood episodes but also during remission periods. These rates are quite similar to those reported as regards to functional impairment. In fact, it is estimated that only one third of patients achieve full social and occupational recovery and get back to their premorbid levels. Moreover, neurocognitive deficits, together with other clinical and sociodemographic variables are thought to contribute to functional impairment for bipolar disorder, similarly to that found in schizophrenia. Little is published with regard to neurocognitive remediation in bipolar disorder. The first open label study on bipolar disorder was published in 2010 with positive results. Recently, a multicenter randomized clinical trial coordinated showed efficacy of an innovative intervention at improving functioning and reducing disability of bipolar patients. There is a need of investigating novel and creative ways to work on cognitive deficits including new technologies in order to reduce costs and increasing benefits for patients. No study addressing computerized cognitive training in bipolar disorder has been developed so far. This project aims to test the efficacy of an e-neurocognitive module as an adjunct to functional remediation in bipolar patients.

NCT ID: NCT02477904 Completed - Clinical trials for Autism Spectrum Disorder

Ketogenic Diet Therapy for Autism Spectrum Disorder

Start date: March 2015
Phase: N/A
Study type: Interventional

This study will assess the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating autism spectrum disorder (ASD). Three study groups will be comprised of children (2-21 years of age) based on whether or not they have ASD and receive the ketogenic diet - ASD/ketogenic diet, ASD/non-ketogenic diet, and non-ASD/non-ketogenic diet.

NCT ID: NCT02477280 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance

Start date: September 2016
Phase: Phase 4
Study type: Interventional

Aim: The purpose of the study is to examine the effects of medication, placebo and expectation on objective and self-rated performance of ADHD core signs during the Quantified Behavior Test in patients with untreated ADHD and substance Use Disorders. Subjects: Participants are 40 consecutive patients remitted to a neuropsychiatric investigation at the Dependence Clinic Västmanland, Västerås, Sweden. Method: The study is a double-blind, randomized, placebo-controlled, cross-over study. The study is taken place during four hours on two investigating days, separated by a 4 days wash-out period. All patients participate on two occasions: In one session they receive the Methylphenidate (MPH) condition, and in the other session they receive the placebo condition. MPH and placebo conditions are counterbalanced across subjects such that half of the participants receive MPH first, and half receive placebo first. Neither the patient nor the research assistant is aware when the participant receive the MPH condition or the placebo condition. On each investigating day the participant accomplish Questionnaires (Visual Analogical Scales) concerning; (a) expectation, (b) self-rated performance, (c) exhausting exercise, (d) perceived help from the pill and (e) self-rated symptoms. In addition the participant completed A Quick Test of Cognitive Speed (AQT) and two separate Quantified Behavior Test Plus (QbTest) without medication vs MPH/Placebo. QbTest aims to provide objective information regarding core-symptoms of ADHD; hyperactivity on the basis of motor-activity measured with the camera, and inattention and impulsivity on basis of the CPT-test.

NCT ID: NCT02476877 Completed - Schizophrenia Clinical Trials

A Pilot, Proof-of-concept Cohort Study of the Prevalence of Comorbid Mental Illness and Substance Abuse

Start date: June 2014
Phase: N/A
Study type: Observational

The prevalence estimates for specific mental disorders and illicit drugs have been separately reported in U.S. government surveys. Less is known about the rates for specific comorbid conditions, e.g., schizophrenia and substance abuse, major depression and substance abuse, bipolar disorder and substance abuse, and anxiety disorder and substance abuse. The effects that different demographic characteristics (ethnic background, family medical history, age, living conditions [e.g., living with a single parent]) have on the prevalence of comorbid mental illness and substance abuse also have not been considered. More should be known about the duration of substance abuse in different mental illnesses among those undergoing treatment, and whether specific types of drugs are associated with specific mental illnesses. In this study, Advanced Clinical Laboratory Solutions, Inc. will investigate the prevalence rates for the specific comorbid conditions and demographic relationships described above. This multi-site, proof-of-concept cohort study will analyze urine or oral fluid samples from 1,000 subjects diagnosed with one of four mental illnesses (schizophrenia, major depression, bipolar disorder, or anxiety disorder) as determined by DSM-IV (The Fourth Edition of the Diagnostic and Statistical Manual of Mental Disorders). The samples will be analyzed for both prescription drug compliance and illicit substance abuse. Urine or oral fluid samples will be collected at three time points: 1) immediately after enrollment and obtaining informed consent, 2) randomly within 2 to 4 months of the study, and 3) at the end of the study (6 months).

NCT ID: NCT02476058 Completed - Clinical trials for Major Depressive Disorder

A Safety, Efficacy and Biomarker Study of JNJ-42847922 in Participants With Major Depressive Disorder

Start date: June 11, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of JNJ-42847922 in participants with Major Depressive Disorder (MDD).

NCT ID: NCT02475096 Completed - Clinical trials for Functional Gastrointestinal Disorders

Internet-delivered CBT for Children With Functional Gastrointestinal Disorders - an Open Pilot Study

Start date: July 2015
Phase: N/A
Study type: Interventional

This pilot-study aims to evaluate the effect size and feasibility of internet-delivered cognitive behavior therapy (ICBT) for children (age 8-12 years) with pain-predominant functional gastrointestinal disorders (e.g. irritable bowel syndrome, functional abdominal pain and functional dyspepsia according to the Rome III criteria). The main component investigated in this study is exposure for gastrointestinal symptoms and for feared stimuli and situations. Children will participate along with one of their parents in the treatment. The parents will also receive specific modules with information on how to support their child in the treatment.

NCT ID: NCT02474524 Completed - Schizophrenia Clinical Trials

Self-Management and Recovery Technology Psychosocial Intervention Trial

SMARTTherapy
Start date: January 1, 2015
Phase: N/A
Study type: Interventional

This project is a component of a broader research program referred to as "Self-Management and Recovery Technology (SMART): Use of online technology to promote self-management and recovery in people with psychosis", which has been funded by the Victorian Department of Health Mental Illness Research Fund (MIRF33). The overall research program is examining the therapeutic potential of using online (Internet-based) educational and multimedia resources in mental health services. It involves the development of a website which can be accessed via an internet browser on a desktop computer, tablet computer, or smartphone. It consists of a series of educational modules containing textual information, exercises, audio, and video clips designed to promote self-management and recovery in people with a history of persisting mental illness. This particular project (SMART-Therapy) involves a randomised controlled trial examining the use of a discrete 8-session psychosocial intervention delivered in addition to routine care which utilises these online materials. The intervention will involve a mental health worker meeting with the participant with a tablet computer (e.g. iPad) on which online materials can be viewed, and used to guide an interaction with the participant. The randomised controlled trial will include 148 participants, who will be randomised to receive one of two interventions: (a) meeting with a support worker using the SMART website to guide interaction (health intervention), or (b) meeting with a support worker delivering a social interaction-based control condition (social intervention). In each condition, there will be 8 x 50min face-to-face sessions over 3 months. Assessments will be completed pre-randomisation, and at 3, 6 and 9 months. The primary hypothesis is that participants randomised to the health intervention will show greater improvement in personal recovery than participants randomised to the social intervention, and that these improvements will be maintained at follow-up (6 and 9 months following intake).

NCT ID: NCT02473783 Completed - Clinical trials for Major Depressive Disorder

The Serotonin Transporter Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Detecting MDD

STAPMDDTDM
Start date: October 2011
Phase: Phase 2
Study type: Interventional

Objectives: 1. To evaluate the relationship between improvement of Hamilton Depression Rating Scale (HAMD) score and basal SERT availability (binding potential) for the prognosis of MDD subjects being treated with Sertraline HCl 2. To evaluate the SERT availability by means of I-123-ADAM SPECT imaging study for assisting in detecting MDD 3. To evaluate the relationship between basal HAMD score and basal SERT availability for MDD subjects 4. To evaluate the relationship between basal HAMD somatic subscale score and basal SERT availability for MDD subjects 5. To evaluate the relationship between change of SERT availability and change of HAMD score for MDD patients being treated with Sertraline HCl

NCT ID: NCT02473289 Completed - Clinical trials for Depressive Disorder, Major

An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder

Start date: July 23, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of sirukumab as adjunctive treatment to antidepressant therapy (monoaminergic antidepressant) where sirukumab (administered as a 50 milligram (mg) subcutaneous (SC) injection at Day 1, Day 28 and Day 56 during the 12- week double-blind treatment period) is compared to adjunctive placebo based on the change from baseline to 12-week endpoint in depressive symptoms as measured by the total score on the Hamilton Depression Rating Scale (HDRS), in participants diagnosed with Major Depressive Disorder (MDD) who have had a suboptimal response to the current standard oral antidepressant therapy and have a screening high sensitivity C-Reactive Protein (hsCRP) >=0.300 milligram per deciliters (mg/dL) (International System of Units (SI) 3.00 mg/L). A cohort of subjects with hsCRP <0.300 milligram per deciliter will also be enrolled to allow a better understanding of the relationship between CRP and clinical changes.

NCT ID: NCT02472860 Completed - Clinical trials for Autism Spectrum Disorder

Feasibility and Effectiveness of Computerized Cognitive Training in Adolescents With Autism Spectrum Disorder

MGHTCT
Start date: June 2015
Phase: N/A
Study type: Interventional

The investigators will conduct a randomized placebo-controlled trial of a computerized intervention targeting cognition in 30 teens with autism spectrum disorder.