Active clinical trials for "Psychotic Disorders"

Rationale: There is growing consensus that targeting negative symptoms such as social withdrawal is essential to be able to preserve social participation, thereby reducing the high yearly costs of schizophrenia. Aaron T. Beck, founder of Cognitive Behavioural Therapy (CBT), and colleagues have developed and investigated a new CBT approach, in which they target inactivity in a chronic schizophrenia population with severe negative symptoms The therapy is based on accumulating evidence that dysfunctional beliefs in conjunction with neurocognitive impairments can impede social functioning. These results suggest that CBT can be highly successful in establishing clinically meaningful improvements. However, the therapy has not yet been investigated in a recent-onset population. Objective: To evaluate the applicability and (cost-) effectiveness of a shortened, partly group based, Cognitive Behavioural Therapy focussing on social activation (CBTsa) in patients with recent onset schizophrenia. Hypotheses: 1) the investigators hypothesized that CBT focused on social activation (CBTsa) in a recent-onset population will result in a substantial reduction in severity of negative symptoms, in particular social withdrawal. 2) The investigators expected that CBTsa would lead to an improvement in terms of Quality of Life and overall functioning. 3) The investigators expected this intervention to result in a reduction in need for care and QALY gain as a consequence of improvement in symptoms and social functioning. Study design: Single blind randomized controlled trial with 6 month-follow up. Study population: Patients between 18 and 35 years old with negative symptoms of at least moderate severity, and who have been recently (< 2yrs) diagnosed with schizophrenia. Intervention (if applicable): Individual and group-based CBT intervention targeting social withdrawal. Main study parameters/endpoints: Change in negative symptoms, Social functioning, and quality of life, Productivity losses.

This randomised three-arm study aims to evaluate the efficacy and feasibility of a cognitive behavioral therapy (INT-Integrated Neurocognitive Therapy for Schizophrenia Patients) in the treatment of schizophrenia patients in an inpatient setting. The intervention will be compared with an active comparator (IPT- Integrated Psychological Therapy) and a control condition. Overall the study will include 90 patients (30 in each arm). Each patient will receive at least 16 sessions of the respective treatment. Baseline and follow up assessments up to 12 months after the intervention will investigate the stability of treatment.

There is increasing clinical and molecular evidence for the role of hormones and specifically estrogen and its receptor in schizophrenia. A selective estrogen receptor modulator, raloxifene, stimulates estrogen-like activity in brain and can improve cognition in older adults. The present study will test the extent to which adjunctive raloxifene treatment improved cognition and reduced symptoms in young to middle-age men and women with schizophrenia. 110 patients with a schizophrenia spectrum disorder will be recruited in a multicenter twelve-week, randomized, double-blind, placebo-controlled, parallel trial of adjunctive 120mg raloxifene treatment in addition to their usual antipsychotic medications. The investigators hypothesize that daily treatment with raloxifene 120 milligrams (mg) in addition to antipsychotic treatment improves cognition, reduces psychotic symptoms, increases social and personal functioning and reduces health care costs, as compared to placebo.

For the present study, Investigators will examine the efficacy of active prefrontal anodal tDCS versus placebo (sham) interventions to treat WM dysfunction in schizophrenia. Investigators selected the prefrontal stimulation modality that proved most effective in enhancing high-load WM performance in single dose stimulation in healthy participants . The study employs a multi-stimulation approach, with 2 sessions per day for 5 consecutive days in the active treatment group (n=15) compared to a group that receives only sham stimulation (n=15). This preliminary approach is based upon findings of a recent study applying cathodal tDCS stimulation over left temporoparietal cortex (with left prefrontal anodal stimulation) for the treatment of persistent auditory hallucinations in schizophrenia. In a a recent study clinical benefits were maintained for at least 3 months following stimulation. In the present study, in addition to clinical outcome, researchers will evaluate whether similar improvement can be obtained with WM, EEG activity, and functional outcome (e.g., discharged from hospitalization following significant improvement or remission).

Social functioning deficits are among the most disabling and difficult to treat aspects of schizophrenia. An essential component of social functioning is metacognition-a process that is profoundly disrupted in schizophrenia and represents the ability to reflect upon the mental states of oneself and others. To date, treatment efforts in schizophrenia have been hindered by barriers in accurately monitoring client's real-world social interactions. Recently, wearable technologies have evolved to provide therapists with innovative, ecologically-valid tools. The Electronically Activated Recorder is a wearable audio recorder that collects behavioral samples at pre-programmed intervals; it holds great promise as a method for yielding concrete, real-world examples of social interactions that can be used by therapists in session to enhance metacognition. Despite the immense costs of social functioning deficits, no previous studies have investigated whether functioning can be improved by integrating wearable audio recorders with psychosocial interventions. By enhancing therapy using a wearable recording device, this proposal's primary goal is to implement a novel intervention that targets metacognitive deficits to improve social functioning. The novel intervention will be tailored to individual clients-based on the content of recorded social interactions-in a way that is not possible using traditional psychotherapy. This will allow clients and therapists to step out of the therapy room by offering a window into how clients process material in real-world interactions. In this study, a randomized controlled trial will be conducted with two schizophrenia groups receiving six months of individualized: 1) Metacognition Reflection and Insight Therapy (MERIT) alone (Standard MERIT); and 2) Tailored MERIT using wearable audio recorders. In this study, our specific aims will test feasibility, effectiveness, and acceptability of Tailored MERIT.

Purpose: To test the effectiveness of an exercise intervention that combines group walking, activity tracking, and heart rate monitoring (i.e. Physical Activity can Enhance Life, PACE-Life) on the physical and mental health for individuals with schizophrenia spectrum disorder. Participants: 50 individuals with schizophrenia spectrum disorders. Procedures (methods): During the baseline assessment, which can be completed virtually and in-person (based on participant preference) all participants will be provided with a Fitbit wristband and instructed how to use it. During the first group session, participants will be taught how to use their heart rate (on the Fitbit) to determine how fast participants should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart rate from the watch, to guide the intensity of the walk, will be provided to participants and reviewed at each group session. Participants randomly assigned to the PACE Life virtual walking group sessions will meet the other group members and group leaders and be reminded of the heart rate (HR) that corresponds with the intensity of that group session. Next, the group will exercise for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention. At the completion of the sessions, everyone will take a break for water and review the walk. After the second group session of each week, participants will receive weekly progress reports of their steps and minutes spent walking the prior week (obtained from Fitbit devices). During this session, participants will also set individual goals for the upcoming week for both their "intensity walks" and total steps per day. Participants randomly assigned to Fitbit Alone will be given a Fitbit and shown how to use it by study staff. Participants will also be given information on current recommended physical activity guidelines (150 min/week of moderate intensity exercise) and will be told that study staff may be contacting them on a weekly basis (or shorter, if necessary) if it looks like participants are not wearing their Fitbit for a certain number of days (e.g. 3 consecutive days) or to troubleshoot any issues. If necessary, participants might be invited to meet with research staff to get assistance on any Fitibit or exercise-related issues.

In this study, the investigators will be examining the effects of repetitive transcranial magnetic stimulation (rTMS) and intermittent theta burst stimulation (iTBS) on social cognitive impairments in individuals with schizophrenia spectrum disorders. Participants will be chosen by chance to receive either active rTMS stimulation, active iTBS stimulation, sham rTMS, or sham iTBS. The investigators predict that active 10Hz and iTBS stimulation will improve social cognitive impairments compared to sham stimulation. We aim to identify which type of active stimulation is most effective at inducing changes social cognition brain circuitry and secondarily which type of active stimulation is best tolerated and most effective at inducing changes in social cognitive performance.

This study will investigate the efficacy and safety of RO6889450 as monotherapy in participants experiencing an acute exacerbation of symptoms of schizophrenia or schizoaffective disorder.

Multi-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%.

The acute phase of this study will monitor the response to a combination of an atypical antipsychotic medication olanzapine with an antidepressant medication sertraline in the acute treatment of the disorder. It is predicted that this combination will improve symptoms of psychotic depression and be associated metabolic side effects. Factors that moderate tolerability will be monitored. Improvement in symptoms could take between 4 and 12 weeks, followed by a period of 8 weeks during which participants will continue to take the same medications to stabilize the remission from symptoms of psychotic depression. The maintenance phase will be a randomized, double-blind, placebo-controlled study of olanzapine for a period of up to 36 weeks to test whether continuing this combination decreases the risk of relapse and whether discontinuing the combination leads to improvement in metabolic measures. Subjects who complete the acute phase will be asked to consent separately to the randomized maintenance phase.