Active clinical trials for "Psychotic Disorders"

The aims of this study are to compare the antipsychotic and adverse events of quetiapine, an atypical antipsychotic drug, to haloperidol, a standard treatment for primary psychotic disorder, in individuals with MAP.

Schizophrenia/Schizoaffective Disorder is associated with serious problems with cognitive skills, social skills, and functional skills (like employment). There is a new form of cognitive behavioral therapy called integrated cognitive behavioral therapy (iCBT) that specifically addresses the cognitive, social, and functional deficits of schizophrenia/schizoaffective disorder. This study compared iCBT to the usual care (UC) that Veteran's receive. The investigators compared iCBT to UC in subjects with schizophrenia/schizoaffective disorder who are enrolled in a Supported Employment (SE) program, and evaluate whether iCBT is more helpful in improving job performance, and other areas of functioning, both right after treatment, and 6 months after the end of treatment.

This study aims to look at the effectiveness of a combination of cognitive remediation and social cognition training to improve cognition and functioning when compared to cognitive remediation alone. The target population will be those who are experiencing their first episode of psychosis.

Schizophrenia is marked by problems in attention, memory and problem solving. These deficits predict long-term functional outcome such as the ability to live independently and maintain employment, but they are not ameliorated by currently available medications. Cognitive training improves these functions to some degree, but this approach is time- and resource-intensive. The current project aims at enhancing and accelerating the benefits that people with schizophrenia derive from cognitive training by administering nicotine during some of the training sessions. This would provide the proof of principle for a type of treatment intervention to improve cognitive symptoms of schizophrenia. The current project aims at determining whether the intermittent presence of nicotine during cognitive training exercises in people with schizophrenia will shorten the training period necessary to induce significant and clinically relevant improvement and enhance the improvement seen after a training period of specified length. Hypothesis 1a: Nicotine administration during training will increase the size of all measured effects of the training intervention, and will accelerate the time course of performance enhancement on the MCCB and training exercise progression parameters. Hypothesis 1b: The larger training effects in the Nicotine Group will persist beyond the end of the intervention. Hypothesis 2a: Within-session progress on the training exercises will be larger in the presence of nicotine than in the presence of placebo. Hypothesis 2b: These acute nicotine-induced performance elevations will persist beyond the presence of nicotine through subsequent non-drug training sessions, giving evidence of an acute facilitation of learning processes.

The proposed project is designed to examine the effects of cognitive rehabilitation on brain structure and function in a randomized trial of 102 early course schizophrenia patients treated for 18 months with either cognitive enhancement therapy (CET) or an Enriched Supportive Therapy (EST) control, and then followed-up at 1-year post-treatment.

The purpose of this study is to assess the efficacy of oral glycine as an augmentation strategy in two psychotic patients with a triplication (4 copies) of the gene glycine decarboxylase (GLDC). Subjects will first undergo a double-blind placebo-controlled clinical trial in which one 6-week arm will involve glycine (maximum daily dose of 0.8 g/kg, administered on a TID dosing schedule) and one 6-week arm will involve placebo. A 2-week period of no treatment will occur between treatment arms. A 6-week period of open-label glycine (maximum daily dose of 0.8 g/kg, administered on a TID dosing schedule) will follow the double-blind placebo-controlled clinical trial. Prior to the double-blind placebo-controlled clinical trial and at the end of the open-label glycine trial, the following procedures will be carried out: structural MRI (3T), Proton 1H MRS (4T), fMRI (3T), steady-state visual evoked potentials, and EEG. Positive, negative, and affective symptoms and neurocognitive function as well as plasma levels of large neutral and large and small neutral and excitatory amino acids and psychotropic drug levels will be assessed periodically. In addition, 1H MRS (4T) for 2 hours after a single oral dose of a glycine-containing drink will be assessed at baseline. Pharmaceutical grade glycine powder (Ajinomoto) or placebo will be dissolved in 20% solution and prepared by the McLean Hospital Pharmacy. Because the results of the double-blind placebo-controlled and open-label glycine treatment arms showed substantial clinical benefit to the participants, the study has been extended to include six months of chronic open-label glycine in order to determine 1) whether the clinical benefits achieved within 6 weeks previously recur, 2) the clinical benefits are lasting, and 3) additional clinical benefits occur with longer exposure. The glycine for this extension will be provided by Letco Medical. The investigators hypothesize that mutation carriers will have reduced endogenous brain glycine and GABA levels and increased brain glutamate and glutamine levels. Glycine administration will increase brain glycine in the two carriers, but to a lesser extent than in non-carrier family members and controls. The investigators hypothesize reduced activation of magnocellular pathways and abnormal ERPs modulated by NMDA in mutation carriers compared with non-carrier family members and controls. The investigators hypothesize that glycine, but not placebo, will improve positive, negative and affective symptoms as well as neurocognitive function. The investigators also hypothesize that open-label glycine will improve clinical and cognitive functioning, will partially normalize decreased baseline glycine and GABA and increased glutamate and glutamine, and will partially normalize magnocellular pathway activation and abnormal evoked potentials.

This Phase I/IIa Proof-of-Concept (PoC) trial is designed to assess the effect of adding a single and repeated low dose (15mg/d) of pipamperone (PIP) for 6 weeks to stable treatment with an effective dose of risperidone (RIS) or paliperidone (PAL) on functional MRI tests and clinical outcome of chronic schizophrenic patients with residual, so-called 'positive' symptoms, as well as on cognition, motivation, subjective well-being of patients, negative symptoms, general psychopathological symptoms and safety/tolerability.

The objective of this study is to evaluate the efficacy and safety of RP5063 relative to placebo for the treatment of schizophrenia or schizoaffective disorder.

The rate of type-2 diabetes mellitus (T2DM) is at least 2-3 times higher in persons with psychotic illnesses than in the general population. Life expectancy of individuals with psychosis is also 20-25 years less than the general population, primarily due to premature onset of cardiovascular disease (CVD). Despite the high risk for T2DM and CVD, psychotic illness has been an exclusion criterion in all large-scale studies of diabetes prevention and management. We propose a 3-year randomized controlled trial examining the effectiveness of a lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity in overweight or obese individuals (N=150) suffering from both a psychotic illness and T2DM. Weight and glycemic control will be the primary outcome variables. It is hypothesized that a significant weight reduction and improvement in glycemic control will be found in those who receive the LI relative to those who do not.

This study is designed to look at the effects of naltrexone on weight loss in individuals treated with antipsychotic medications. Naltrexone is an FDA approved medication for the management of alcohol dependence and drug dependence, but has not been fully evaluated for its effect on weight loss in individuals with severe mental illness (i.e. schizophrenia, schizoaffective disorder, bipolar disorder etc.) The purpose of this study is to find out how effective two different doses of oral naltrexone is on reducing body weight when compared to placebo (an inactive substance or "sugar pill").