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Mental Disorders clinical trials

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NCT ID: NCT01122927 Terminated - Clinical trials for Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.

ATTAIN 267
Start date: July 2010
Phase: Phase 3
Study type: Interventional

This is an open-label study consisting of a screening period, a conversion/titration phase (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period. The study will enroll new subjects (hereafter referred as "de novo" subjects) with schizophrenia, or bipolar I disorder, manic or mixed episode with or without psychotic features, and rollover subjects with schizophrenia from 31-09-266 (hereafter referred to as "Study 266"). All de novo subjects must enter the screening period of the study. Subjects who are screened and are not required to go through Phase 1 will complete a Phase 2 baseline visit prior to their participation in Phase 2. Study Design: Treatment, Single Group Assignment, Open Label, Active Control, Safety/Efficacy Study

NCT ID: NCT00955474 Terminated - Clinical trials for Major Depressive Disorder With Psychotic Features

Seroquel Alone Versus Seroquel With an SSRI for Depression With Psychotic Symptoms

Seroquel
Start date: September 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy and tolerability of Seroquel monotherapy for the treatment of Major Depression with Psychotic features with Seroquel plus Selective Serotonin Reuptake Inhibitor.

NCT ID: NCT00867360 Terminated - Depressive Disorder Clinical Trials

Treatment of Psychotic Major Depression With Mifepristone

Start date: August 2005
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to see how certain hormones cause changes in mood and thinking in some depressed patients and to determine the effectiveness of mifepristone in treating some forms of depression. This study is conducted in conjunction with an observational study "Clinical and Biological Characteristics of Psychotic Depression".

NCT ID: NCT00757497 Terminated - Schizophrenia Clinical Trials

Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia

Start date: September 17, 2008
Phase: Phase 1
Study type: Interventional

This study will test whether transcranial direct current stimulation (TDCS) can be used safely in children with schizophrenia and if it can improve memory and attention span or auditory hallucinations in these children, at least temporarily. TDCS has temporarily improved memory and attention span in healthy adults and a similar method called TMS has relieved auditory hallucinations in adults with schizophrenia. For the TDCS procedure, the child sits in a chair and two soft sponge electrodes are placed on the child s forehead and held in place with a soft wrapping. One sponge electrode is placed on an arm. The electrodes are attached to a stimulator with a wire. Children with schizophrenia who meet the following criteria may be eligible for this study: - Are 10 yrs or older age. - Are participating in NIH protocol 03-M-0035. - Are on a stable medication regimen for at least 6 months. - Have problems with memory and attention span or have auditory hallucinations. Participants are randomly assigned to receive either real or sham TDCS on an inpatient or outpatient basis in 20-minute sessions daily, except weekends, for 10 days. For real TDCS, patients receive stimulation to the front of the brain. For sham stimulation, the children have electrodes placed on the forehead, but no actual stimulation is delivered. In addition to TDCS, patients have the following procedures: - Checks of blood pressure, pulse and breathing rate before, during and right after each stimulation and again 8 hours later. - Electrocardiogram (EKG) and electroencephalogram (EEG) before starting stimulation and after completing the 10 days of TDCS. - Interviews and examinations to check for side effects of TDCS. - Pen-and-paper or computer tests of learning, attention and memory. - At the end of the 10 sessions, children who were in the sham TDCS group are offered the same number of sessions of active TDCS. - Follow-up telephone call 1 month after the end of stimulation to see how the child is doing. - 1- to 2-day outpatient visit 6 months after the stimulation. This visit includes interviews with the parent and the child, rating of the child s psychiatric symptoms, and pen-and-paper or computer tests of thinking, attention and memory.

NCT ID: NCT00750919 Terminated - Mental Disorders Clinical Trials

Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)

Start date: October 7, 2008
Phase: Phase 3
Study type: Interventional

This trial is a 26-week, open label extension trial to investigate safety and explore efficacy of esmertazapine in participants with insomnia who completed protocol 21106/P05701/MK-8265-002 (NCT00631657).

NCT ID: NCT00748566 Terminated - Clinical trials for Schizophrenia and Disorders With Psychotic Features

One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome

Start date: December 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to explore the impact of ziprasidone on the distribution of metabolic syndrome risk factors in a population of patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.

NCT ID: NCT00745030 Terminated - Parkinsonism Clinical Trials

Efficacy and Tolerability of Ramelteon in Patients With Rapid Eye Movement (REM) Behavior Disorder and Parkinsonism

Start date: June 2008
Phase: N/A
Study type: Interventional

Parkinson's disease (PD) is the second most common neurodegenerative disorder of the elderly that affects a million patients in US. Sleep dysfunction impacts up to 90% of PD patients. PD patients experience a variety of sleep disorders including parasomnias, specifically REM behavior disorder (RBD) that can precede the onset of motor manifestations of PD. RBD has negative consequences on patients' and their bed partners' quality of life mainly due to its impact on the sleep quality and day time alertness. RBD also predisposes affected individuals and their bed partners to physical injuries. There are no FDA approved treatments for RBD. Clonazepam is the most commonly used treatment but carries risks of daytime sedation, tolerance, and withdrawal symptoms. More recently, melatonin has been demonstrated to be effective in several small studies. Ramelteon, a selective melatonin receptor agonist with favorable safety profile, could potentially be effective for the treatment of RBD. This pilot protocol will investigate safety and efficacy of ramelteon for the treatment of RBD in subjects with parkinsonism. We plan to recruit 20 subjects with RBD diagnosed based on the clinical interview and confirmed by the polysomnographic (PSG) data. The study is designed as a prospective randomized placebo controlled 12-week study. Primary outcome measure will be change in frequency of RBD events based on the daily sleep diaries. Secondary outcome measure will be change in the amount of tonic muscle activity based on the results of the baseline and final PSG. A number of other secondary and exploratory outcome measures will be collected

NCT ID: NCT00725270 Terminated - Depressive Disorder Clinical Trials

Treatment of Schizoaffective Disorder Using Mifepristone

Start date: April 1998
Phase: Phase 2/Phase 3
Study type: Interventional

This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.

NCT ID: NCT00715377 Terminated - Schizophrenia Clinical Trials

Anticholinergic Burden in Schizophrenia

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

Anticholinergic antiparkinsonian agents often cause side-effects including cognitive impairment, dry mouth, and constipation while they diminish antipsychotic-induced parkinsonian symptoms. The introduction of second generation antipsychotics (SGA) brought fewer neurological side effects. However, anticholinergic coprescription rates are still as high as 12-65% in patients on SGA that are much higher than the incidence of EPS reported in clinical trials (3-20%). This apparently discrepancy is likely explained, in part, by the established tradition of routine use of this medications. Older patients are particularly sensitive to anticholinergic side-effects due to age-related changes in pharmacokinetics and pharmacodynamics. In this study, we will examine the safety and benefits of reducing the dose of a frequently prescribed anticholinergics, benztropine, on cognitive function, extrapyramidal symptoms, and psychotic symptoms in older subjects with a primary psychotic disorder.

NCT ID: NCT00637494 Terminated - Psychosis Clinical Trials

A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features

Start date: March 2008
Phase: Phase 3
Study type: Interventional

Approximately 450 patients will be randomized to receive Mifepristone or placebo for 7 days followed by antidepressant. The purpose is to compare the efficacy of Mifepristone followed by antidepressant versus placebo followed by antidepressant in reducing psychotic symptoms in patients with a diagnosis of psychotic depression.