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Psychotic Disorders clinical trials

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NCT ID: NCT00942981 Recruiting - Schizophrenia Clinical Trials

Functional Relevance of Dopamine Receptors in Healthy Controls and Patients With Schizophrenia: Characterization Through [11C]NNC-112 and [18F]Fallypride Positron Emission Tomography

Start date: November 13, 2009
Phase:
Study type: Observational

Background: - Some illnesses, such as schizophrenia, have effects on brain cells called dopamine receptors, which are required for normal brain function. People with schizophrenia have difficulty thinking and experience hallucinations and delusions. Medications that change brain dopamine receptors can decrease these hallucinations and delusions. - The cause of schizophrenia and its association with brain dopamine receptors is not known but may be clarified by studying dopamine receptors in people who have dopamine disorders (such as schizophrenia) and those who do not. Researchers are interested in studying the dopamine system to gain a better idea of how dopamine disorders develop, which may lead to better medical care for people with schizophrenia. Objectives: - To study the amount and distribution of two types of dopamine receptors. Eligibility: - Individuals between the ages of 18 and 60 who have schizophrenia. - Healthy volunteers between the ages of 18 and 90. Design: - Participants will undergo a full screening, with physical and psychological history, a neurological examination, and blood and urine samples. - Participants will have a blood flow map of the brain recorded with a positron emission tomography (PET) brain scan. A magnetic resonance imaging (MRI) scan will also be performed to determine brain anatomy. - To study the amount and distribution of dopamine receptors in the brain, participants will receive a small amount of a radioactive chemical in the vein, followed by a PET scan. - The procedure will be performed twice in two separate sessions, once for [18F]fallypride and once for [11C]NNC-112.

NCT ID: NCT00942097 Completed - Pregnancy Clinical Trials

Homeopathic Medication and Nutritional Oriented Diet to Treat Overweight Pregnant Women With Mental Disorder

Start date: August 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of homeopathic treatment in pregnant women with overweight and class I obesity with suspicion of a mental disorder.

NCT ID: NCT00936351 Completed - Schizophrenia Clinical Trials

Mindfulness Meditation as a Rehabilitation Strategy for Persons With Schizophrenia

Start date: December 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to develop a treatment manual for mindfulness meditation to be taught in a group format to individuals with schizophrenia who are engaged in vocational rehabilitation. This study will also determine whether mindfulness meditation is beneficial in terms of improving work function by reducing distressing emotional states and thinking patterns.

NCT ID: NCT00932529 Completed - Psychotic Disorders Clinical Trials

Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting

BPP
Start date: February 2003
Phase: Phase 4
Study type: Interventional

Despite different pharmacological properties, the scientific evidence is inconclusive regarding which of the first-line second generation antipsychotics (SGAs) should be preferred for the individual patient suffering from psychosis. The limitations of the evidence base may be related to the highly selected samples, short duration, and rigid experimental designs of most randomized clinical trials of efficacy. Moreover a high proportion of the clinical trials are drug company sponsored which could introduce funding bias. The purpose of this non-commercially funded study is to investigate whether effectiveness differences exist among the first-line SGAs olanzapine, quetiapine, risperidone, and ziprasidone when the drugs are used in a representative clinical setting. Eligible patients are those admitted to hospital for acute psychosis and candidates for oral antipsychotic treatment. The investigators hypothesise that in the naturalistic setting of every-day clinical practice and in a diverse sample representative of most patients admitted for symptoms of acute psychosis, differential effectiveness among the SGAs could be disclosed when the patients are followed for up to 2 years. This could deliver valuable information regarding which SGA should be the starting antipsychotic drug in order to facilitate the most beneficial outcome.

NCT ID: NCT00929955 Completed - Schizophrenia Clinical Trials

Role of Anti-Inflammatory Agents in Patients With Schizophrenia

Start date: June 2009
Phase: Phase 1
Study type: Interventional

There is some evidence that anti-inflammatory treatment may have beneficial effects in schizophrenia and major depression. Cox-2 inhibitors have been tested in preliminary clinical trials for schizophrenia and depression, showing favourable effects compared to placebo (Muller and Schwarz et al 2009). Statins were introduced as cholesterol-lowering agents but have found much wider usage. They are anti-inflammatory agents and thus similar to the Cox-2 inhibitors, which have shown some ability as adjuncts to improve the symptoms of schizophrenia in preliminary studies. The statins are also known to decrease C-reactive protein (CRP), which has been shown in an SMRI-funded study to be elevated in a study of individuals with schizophrenia. Fan et al (2007) demonstrated in a small study in patients with schizophrenia that higher than normal levels of CRP (>0.50 mg/dl) was associated with marked negative symptoms and higher total PANSS scores. Ondansetron is a serotonin (5-HT3) receptor antagonist that is generic and widely used to prevent nausea and vomiting in patients receiving chemotherapy for cancer. GSK did a small study on it as an antipsychotic in the 1980s. Since then, several small studies have suggested that it is effective as an adjunct drug in improving the symptoms of schizophrenia. Statins are widely used in schizophrenia sufferers, particularly those taking second generation antipsychotics, to treat hypercholesterolemia. Both drugs are well tolerated and their side effect profiles well understood. We propose to conduct a feasibility study in patients with chronic schizophrenia to explore the adjunct use of simvastatin and ondansetron on positive, negative and general psychopathology in comparisons to treatment as usual (TAU) over a 12 week period.

NCT ID: NCT00919620 Completed - Psychotic Disorders Clinical Trials

Stage-specific Case Management for Early Psychosis

Start date: June 2009
Phase: N/A
Study type: Interventional

One of the commonly adopted strategies in improving outcome in psychotic disorders is by focused, specific and intensive intervention in the initial few years of the disorder. However the effects of intervention and the optimal duration of intervention have seldom been examined in randomized studies. This study uses a randomized controlled study design to investigate the effectiveness of stage-specific case-management in improving outcome of first episode psychotic disorders. It also addresses whether two years of case-management is less effective than four years of case-management over a four year period. A total of 360 subjects, who aged 25 above, and diagnosed with first episode psychotic disorders, will be and randomized into 3 groups: (1) standard care alone without case management, (2) two-year case management, (3) four-year case management. All groups will receive usual standard care treatment. This four-year follow-up study will assess symptoms, functioning, quality of life as well as health economics data.

NCT ID: NCT00918021 Completed - Schizophrenia Clinical Trials

Polypharmacy in Clozapine-resistant Schizophrenia

CLOZANS
Start date: June 2009
Phase: Phase 4
Study type: Interventional

The aim of this randomized, double-blind study is to verify the hypothesis that clozapine monotherapy is as efficient as a combination of clozapine and olanzapine therapy in treatment-resistant schizophrenia. A third of schizophrenia patients are non -responders to medications used nowadays. These patients are usually treated with clozapine, but a large proportion of patients don't recover sufficiently. Therefore, these patients are treated with combination of two or more drugs to achieve better treatment results. Until now the scientific evidence has been insufficient to assess the utility of polypharmacy. The aim is to study during 2009 with voluntary patients, if there is any benefit of olanzapine augmentation compared with pure clozapine monotherapy. During the study the patients are not exposed to any additional intervention. The intervention in this study is just to reduce the previously used polypharmacy. Methods: This study lasts for 24 weeks. Participants (30) are randomized in one of two alternative interventions (A or B) before the study. After 12 weeks the intervention arms cross over (from A to B and from B to A). Group B: In addition to clozapine, the participants receive their normal dosage of olanzapine (=the same as on the hospital ward) for 12 weeks, next the decreasing dosage of olanzapine for four weeks and subsequently placebo for 8 weeks Group A: : In addition to clozapine the participants receive the decreasing dosage of olanzapine for four weeks, next placebo for 8 weeks, after that the increasing dosage of olanzapine for four weeks and subsequently the normal dosage of olanzapine for 8 weeks The response for the medical treatment is assessed by Clinical Global Improvement Scale (CGIS) and Global Assessment of Functioning (GAF) -scale. The primary outcomes are GAF and modified CGIS during the parallel phase of the study (the first 12 weeks). The second phase (the last 12 weeks) of the cross-over study is used in the secondary analysis. The use of additional medication (such as benzodiazepines) is used as a secondary outcome measure.

NCT ID: NCT00916461 Completed - Clinical trials for First Episode Psychosis

Role of Minocycline in First Episode Psychosis

Start date: May 2006
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether the addition of minocycline or placebo to treatment as usual (TAU): 1. prevents the accumulation of negative symptoms and intellectual decline following a first episode of non-affective psychosis; and 2. whether minocycline stabilizes the efficacy of antipsychotics.

NCT ID: NCT00914238 Completed - Schizophrenia Clinical Trials

Extended Specialized Assertive Intervention for First Episode Psychosis

OPUSII
Start date: July 2009
Phase: N/A
Study type: Interventional

In a randomized clinical trial, the researchers want to investigate if the positive short-term outcomes (first 1-2 years), achieved with specialized assertive intervention programme (OPUS), can be maintained for five years if the specialized treatment is sustained over the first five years in comparison to only two years of specialized treatment followed by three years of standard treatment.

NCT ID: NCT00903916 Completed - Psychotic Disorders Clinical Trials

Effect of Antipsychotics on Appetite Regulation

ADAPT
Start date: August 2007
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate changes in appetite-regulating hormones, body composition (weight, body fat%), and hunger ratings in persons early in treatment with one of four atypical antipsychotic medications (olanzapine, risperidone, ziprasidone, aripiprazole).