
Pan European Collaboration on Antipsychotic Naïve Schizophrenia II
SchizophreniaThe study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve first-episode psychotic patients involving a standardized intervention with monotherapy with aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined after 6 weeks, 6 months and 2 years. They will be examined with MR-scannings, neurocognitive tests, EEG, and PET-scannings.

Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic...
SchizophreniaSchizophrenia and Disorders With Psychotic Features1 moreThe main objective of the trial is to evaluate, how long an antipsychotic relapse-prevention should be continued and to which time a patient with schizophrenia is protected enough, so that a withdrawal or reduction of the medication seems appropriate. Relapse is defined as primary outcome.

Motivational Negative Symptoms in Schizophrenia: Intervention and Biomarkers
SchizophreniaSchizoaffective DisorderNegative symptoms significantly interfere with daily functioning among individuals with schizophrenia. They are strongly related to functional impairments [1] and contribute to the poor community outcomes of Veterans with schizophrenia. Motivational negative symptoms interfere with obtaining and maintaining employment [2], forming social relationships[3] and living independently [4]. Developing treatments to effectively reduce negative symptoms is important to achieve improvements in daily functioning. Recent empirical studies report that psychosocial interventions for negative symptoms can have a moderate to large effect size on community functioning and negative symptom severity. However, the treatments that have been utilized so far are either cognitive-behavioral therapy interventions that require over a year of weekly individual sessions and thus are very resource- and time-intensive, or they are skills-training groups that do not address any of the cognitive and motivational aspects of negative symptoms. Although group treatments are increasingly hailed as the gold standard for schizophrenia, there is currently no group intervention explicitly for motivational negative symptoms and functional deficits. Furthermore, treatment development and clinical trials are increasingly reliant on neurophysiological measures of clinical severity and treatment response and so far there are not identified negative symptom biomarkers. The current CDA proposal will test a group-based treatment based on established motivational enhancement (MI) techniques, augmented with cognitive-behavioral approaches, compared to an active control group treatment, for improving motivational negative symptoms in Veterans with schizophrenia. I will assess the efficacy of MI with measures from two outcome domains: 1) negative symptoms (clinical ratings) and 2) functional outcomes (real-world improvements in social, instrumental, and independent living). I will assess the relationship between these outcomes and neurophysiological biomarkers (pupillometry and electroencephalography (EEG)). Participants will be randomly assigned to the MI treatment or a control treatment for weekly 1-hour sessions for 12 weeks. The assessment battery will be administered at baseline, at completion of treatment, and at 6-month follow-up. The investigators will enroll 60 Veterans with schizophrenia that are low functioning and have high negative symptoms across the 4 years of the study. This proposal is designed to examine group-based MI for reducing negative symptoms and improving functioning in key domains (i.e., interpersonal, instrumental, and independent living skills). Moreover, it will thoroughly investigate biomarkers of negative symptoms with pupillometry and EEG. The development and evaluation of this recovery- oriented group MI treatment for Veterans with disabling negative symptoms will yield results that can inform larger treatment trials and neurophysiological measurement of negative symptoms in Veterans with schizophrenia.

Trial of Treatment for Internalized Stigma in Schizophrenia
SchizophreniaThe purpose of the present study is to build upon the investigators' previous exploratory intervention development study by conducting an adequately-powered, randomized controlled trial of the Narrative Enhancement/Cognitive Therapy (NECT) intervention among persons with schizophrenia-spectrum disorders.

A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
SchizophreniaThe study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind, parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.

Comparative Study of Aripiprazole, Quetiapine and Ziprasidone in Treatment of First Episode Psychosis:...
SchizophreniaPsychotic DisordersThe selection of antipsychotic in early stages of the illness is mainly determined by its clinical effectiveness. Second generation antipsychotics (SGAs) are the first line drug treatment for individuals suffering from schizophrenia. It is clear that SGAs are not a homogeneous group and clinical effects and profile of side effects differ between SGAs. Differences among antipsychotics in terms of effectiveness have turned out to be a topic of increasing research interest, although comparisons between the different SGAs are scarce. In first episode of psychosis, SGAs have shown a higher treatment effectiveness compared to first generation antipsychotics (FGAs) (findings primarily driven by Haloperidol). Less evident seems to be the notion that some of the SGAs might be more effective (in terms of treatment discontinuation) than others. Most of the medium-term randomized studies have shown similar rates of all-cause treatment discontinuation in first episode patients treated with different SGAs. It may be concluded that more randomized controlled trails should be accomplished to determine the position of frequently used SGAs in clinical practice. Investigators undertook this study with the major objective of comparing the clinical effectiveness of three widely utilized SGAs (Aripiprazole, Ziprasidone and Quetiapine) in the acute treatment of first-episode non-affective psychosis individuals at 3 years of follow-up.

5-HTR2A, DRD2,and COMT Genes Polymorphisms and Olanzapine Plasma Concentration in Treatment of Early-onset...
Early-onset SchizophreniaIn this study,investigators will recruit 100 DSM-Ⅴdefined EOS Han patients, older than 7 years old and onset of illness before 17 years old, and all EOS patients will receive a 8-week systematic olanzepine titration treatment and a battery of assessments of treatment effect and safety. Blood olanzepine plasma concentration will be tested regularly and genotyping of 8 polymorphisms of 5-HTR2A, DRD2 and COMT genes will be conducted by Polymerase Chain Reaction (PCR), Restriction Fragment Length Polymorphism (RFLP) and TaqMan probes genotyping technology. The aim of the study is to explore the predictive factors on olanzepine treatment response in EOS, which can guide the individualized treatment and improve the cure rate of EOS in clinical setting.

Aerobic Exercise for Cognition in Schizophrenia
SchizophreniaThis study will evaluate the ability of aerobic exercise (AE) to improve cognition in people with schizophrenia. Participants will be randomly assigned to one of two interventions: (1) aerobic exercise class (stationary bicycle, or "spin" class) for up to 45 minutes three times per week for 12 weeks, or (2) balance and stretching class for up to 45 minutes three times per week for 12 weeks.

Person-Centered Versus Measurement-Based Care in Mental Health
SchizophreniaBipolar Disorder1 moreFifteen minutes is the typical length of an outpatient medication management appointment for people with serious mental health conditions. These brief interactions with prescribers are frequently provider-driven with insufficient time focused on the patient's needs and personal recovery. Shared decision making is a strategy that could improve this interaction. This study examines how technology can be used in the care process to amplify the voice of the patient, support shared decisions, and improve treatment outcomes. Investigators will compare the effectiveness of Measurement-Based vs. Person-Centered Care on two primary patient-centered outcomes: the patient experience of care with medication treatment and the level of shared decision making. Investigators hypothesize that: Person-Centered Care will result in greater improvement in patient experience of care with medication treatment than Measurement-Based Care. Person-Centered Care will result in a greater level of shared decision making during the medication visit than Measurement-Based Care. The study team will collect information from patients, caregivers, and clinic staff at different points in time during the study. Patients will be asked to complete questionnaires, and additional data on their service use will be gathered. Some patients and providers will also be interviewed about their experiences with care. Investigators are especially interested to learn if and how these two approaches are perceived to change medication treatment, if patients are more satisfied and empowered in their care, and why and how providers perceive and adopt changes to their clinical care.

Comparative Bioavailability Study of Aripiprazole 10 mg Oral Soluble Film vs Abilify® 10 mg Tablet...
SchizophreniaThe purpose of this study is to compare the rate and extent of absorption of Aripiprazole Oral Soluble Film 10 mg (Test) versus Abilify® 10 mg tablet (Reference) in healthy male volunteers