Active clinical trials for "Psychotic Disorders"

This study will compare standard individualized care to person-centered care and community-integrating care for treating psychosis in adults of Hispanic or African descent.

OBJECTIVE: To test the use of two adjunctive hormonal agents in a 28 day three-arm, double-blind, placebo-controlled study in the treatment of acute mania/hypomania. HYPOTHESIS: That women receiving adjunctive Tamoxifen or Progesterone will demonstrate a more rapid and more substantial decrease in manic symptoms over the course of the study than women receiving adjunctive placebo. STUDY POPULATION: Sixty females with a current diagnosis of Bipolar Affective Disorder or Schizoaffective disorder - Manic Phase, according to the operationalised criteria of the Diagnostic and Statistical Manual, 4th edition (DSM-IV) of the American Psychiatric Association. STUDY MEDICATION: Tamoxifen. One third of patients (twenty) will be randomized to receive adjunctive Tamoxifen at 40 mg/day for 28 days. The Tamoxifen will be administered within a plain capsule to maintain "blinding" of treatment arm. Progesterone. One third of patients (twenty) will be randomized to receive adjunctive oral Provera (progesterone) at 20 mg/day. The Progesterone will be administered within a plain capsule identical to that used with Tamoxifen. Placebo. The remaining one third of patients will be randomized to receive adjunctive placebo (inert substance). The placebo substance will be administered within a plain capsule identical to that used with Tamoxifen and Progesterone. STUDY EVALUATIONS: Data will be collected over a 28-day period for each patient. Visits will be performed at baseline, and then at weekly intervals. A total of five visits will be completed for each patient. The following evaluations will be performed: Psychiatric evaluation to determine diagnosis. (Baseline visit only) General clinical evaluation including medical history, current conditions and a non-invasive physical examination, body weight, vital signs. (Baseline visit only) Medication history (baseline and evaluation visits). Demographics (baseline visits only). Completion of clinical rating scales; CARS-M, PANSS, MADRS, AIMS, Barnes Akathisia scale (BA), and Simpson-Angus scale (SA) (baseline and evaluation visits). A Menstrual Cycle Interview and a cognitive assessment (RBANS) will be performed at baseline and endpoint (day 28) visit. Laboratory tests including; Serum levels of mood stabilizer, luteinizing hormone (LH), follicle-stimulating hormone (FSH), Estrogen, Progesterone, Prolactin, dehydroepiandrosterone (DHEA), Testosterone and protein kinase C(PKC) (baseline and evaluation visits). Inclusion/exclusion checklist (baseline visit only). Informed consent (baseline visit only).

To investigate the 'estrogen-protection' hypothesis by comparing changes in psychotic symptoms between one group of patients receiving standard antipsychotic drug treatment plus placebo and a second matched group receiving standard antipsychotic drug treatment plus 100microgram estradiol patch in a double blind controlled trial. Hypothesis : That the women receiving adjunctive estradiol will demonstrate a more rapid and more substantial decrease in psychotic symptoms over the course of the study than the women receiving adjunctive placebo.

The purpose of this study is to determine whether the administration of omega-3 polyunsaturated fatty acids, particularly eicosapentaenoic acid (EPA), can be useful both to reduce coronary artery disease (CAD) risk and illness severity in clinically-stable patients with schizophrenia (or schizoaffective disorder), major depression or bipolar disorder (depressed phase) being treated with lipid lowering drugs (e.g., statins).

The purpose of the study is to evaluate the effectiveness and safety of different doses of risperidone (an antipsychotic medication) compared with placebo and with a fixed 20 mg/day dose of a standard antipsychotic, haloperidol, in patients with chronic schizophrenia.

This study is to assess the tolerability of bifeprunox with the progressive elimination of titration steps to achieve the shortest tolerated titration dosing to a dose of 40 mg/day in either schizophrenia or bipolar disorder subjects. Study duration is 2 months with an optional open-label 26-week extension study.

The purpose of this study is to evaluate the safety and efficacy of three target doses of melperone compared to placebo in the treatment of psychosis associated with Parkinson's disease. Subjects will be enrolled at approximately 20 investigational sites in the United States (U.S.) and 15 Ex-US sites. The maximum study duration will be 10 weeks. Subjects will have the option of continuing in an open-label extension study.

The primary objective is to compare effectiveness of ziprasidone treatment to current treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric Rating Scale (BPRS) scores versus baseline

Policy makers and consumers are increasingly concerned about the quality and efficiency of care provided to individuals with severe, chronic illnesses such as schizophrenia. These illnesses are expensive to treat and present significant challenges to organizations that are responsible for providing effective care. Occurring in 1% of the United States population, schizophrenia accounts for 10% of permanently disabled people, and 2.5% of all healthcare expenditures. Clinical practice guidelines have been promulgated. Schizophrenia is treatable and outcomes can be substantially improved with the appropriate use of antipsychotic medication, caregiver education and counseling, vocational rehabilitation, and assertive treatment. However, in the VA and other mental health systems, many patients with schizophrenia receive substandard care. Methods are needed that improve the quality of usual care for this disorder while being feasible to implement at typical clinics. To date, most efforts to improve care for schizophrenia have focused on educating clinicians or changing the financing of care, and have had limited success. We believe a more fundamental approach should be tried. While there are many potential strategies, experience in chronic medical illness and mental health support the efficacy of specific approaches. Collaborative care models are one such approach. They are a blueprint for reorganizing practice, and involve changes in division of labor and responsibility, adoption of new care protocols, and increased attention to patients' needs. Although collaborative care models have been successful in other chronic medical conditions, they have not yet been studied in the treatment of schizophrenia. We have developed a collaborative care model for schizophrenia that builds on work in other disorders, and includes service delivery approaches that are known to be effective in schizophrenia. The model focuses on improving treatment through assertive care management, caregiver education and support, and standardized patient assessment with feedback of information to psychiatrists. This project, "EQUIP" (Enhancing Quality Utilization In Psychosis) is implementing collaborative care and evaluating its effectiveness in schizophrenia.

During a psychiatric crisis, persons with severe mental illness (SMI) confront complex challenges concerning treatment choices and are often ill equipped or unable to make mental health care decisions. Psychiatric Advance Directives (PADs) are legal documents that allow competent persons to declare their treatment preferences in advance of a mental health crisis, when they may lose capacity to make reliable health care decisions. The use of PADs is consistent with recommendations of the President�s New Freedom Commission on Mental Illness and the Patient Self-Determination Act; 25 states have now adopted PAD legislation. VA does not have a specific policy for PADs or mechanisms to notify veterans of their right to prepare PADs. The downstream effects of PADs on patient care, crisis management, service use, and clinical outcomes are unknown.