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Bipolar Disorder clinical trials

View clinical trials related to Bipolar Disorder.

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NCT ID: NCT00457054 Completed - Bipolar Depression Clinical Trials

Functional Connectivity in Mood Regulating Circuit In Bipolar Depression and Mania

Start date: July 2003
Phase: Phase 4
Study type: Interventional

The purpose of this study is to find out what parts of the brain have increased or decreased activity with individuals who have bipolar disorder and how medicine changes this activity in bipolar subjects. Another purpose of this study is to compare data obtained from bipolar depressed subjects with data obtained from healthy subjects. In this study we will measure activity in different parts of the brain, while participants see pictures, using Magnetic Resonance Imaging (MRI) scan. We will do two MRI scans with each subject before and after treatment for eight weeks with a standard bipolar disorder medication called lithium.

NCT ID: NCT00454883 Completed - Mania Clinical Trials

Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.

Start date: April 2007
Phase:
Study type: Observational

Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.

NCT ID: NCT00453804 Completed - Schizophrenia Clinical Trials

Injectable Versus Oral Naltrexone Treatment of Alcohol Dependence In Serious Mental Illness (SMI)

vivitrol
Start date: July 2006
Phase: Phase 4
Study type: Interventional

The primary aim of this study is to determine the feasibility of long-acting injectable naltrexone administration in a clinical trial in patients with SMI who also have a diagnosis of alcohol dependence. Secondary aims include providing a preliminary assessment of the tolerability and safety of long-acting injectable naltrexone as compared with oral naltrexone in patients with SMI who also have a diagnosis of alcohol dependence. An additional aim is to provide a preliminary assessment of the efficacy of long-acting injectable naltrexone as compared with oral naltrexone in reducing alcohol use from baseline levels

NCT ID: NCT00453609 Completed - Schizophrenia Clinical Trials

Injectable Naltrexone Treatment of Alcohol Dependence in Serious Mental Illness (SMI)

vivitrol
Start date: April 2007
Phase: Phase 4
Study type: Interventional

The overall goal of this project is to improve the treatment of alcohol dependence in patients with serious mental illness (SMI). SMI for this study is defined as any patient with any of the following diagnoses: schizophrenia, schizoaffective disorder, and bipolar type I or type II disorder. Alcohol and other substance use disorders (SUDs) are common among individuals with SMI. SUD comorbidity is associated with many adverse consequences. However, to date, few reports have addressed the efficacy of pharmacological treatments for SUDs in this population. Naltrexone pharmacotherapy is an effective treatment for alcohol dependence, but it has not been systematically applied to the care of patients with SMI. The primary aim of this study is to determine the feasibility of long-acting injectable naltrexone administration in a clinical trial in patients with SMI who also have a diagnosis of alcohol dependence. Secondary aims include providing a preliminary assessment of the tolerability and safety of long-acting injectable naltrexone in patients with SMI who also have a diagnosis of alcohol dependence. An additional aim is to provide a preliminary assessment of the efficacy of long-acting injectable naltrexone in reducing alcohol use from baseline levels.

NCT ID: NCT00448578 Completed - Bipolar Disorder Clinical Trials

Efficacy and Safety of Seroquel and Lithium as Monotherapy in Acute Mania Treatment in Bipolar Disorder Patients

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

This is a randomised, double blind, double dummy, multicentre, parallel-group study to compare the efficacy and safety of quetiapine and lithium used as monotherapy in the treatment of mania in patients hospitalised for an acute manic episode. After given of informed consent and undergoing screening procedures, the patients will be randomised into quetiapine or lithium group on Day 1. The efficacy of study treatment on symptoms of mania will be assessed at Day 28. Patients will not permitted to use any psychoactive or antipsychotic medications throughout the study period other than those expressly permitted by the protocol. The patients are required to be hospitalised for the treatment and assessment defined in the protocol. He/She could be discharged from the hospital after Week 2 (i.e. On Day 15) if the investigator believes that it will be clinical appropriate to discharge the patient, that the patient is not suicidal or homicidal, and that the patient could reasonably be expected to continue in the study on an outpatient basis. The patients discharged after Day 15 will be given sufficient study medication for the period from discharge to the next visit. At each centre, the same individual will administer a specific psychiatric assessment for a patient at all study visits in order to reduce variability in rating scale scoring. Before the initiation of the study, a consistency assessment will be done among the investigators who conduct the scale assessment in each centre.

NCT ID: NCT00444938 Completed - Bipolar Depression Clinical Trials

Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device in the Treatment of Bipolar Depression

Start date: June 2006
Phase: Phase 1
Study type: Interventional

This study is evaluating the potential antidepressive effect of a 4 week treatment protocol using the H-coil deep TMS device in bipolar depression.

NCT ID: NCT00436020 Completed - Clinical trials for Bipolar Affective Disorder

rTMS in the Treatment of Bipolar Depression

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

Bipolar affective disorder (BPAD) is: - A serious mental illness - Estimated to be present in as high as 6.4% of the population in Western populations - Associated with considerable disability and high morbidity. - Characterized by periods of both lowered and elevated mood (i.e. depression and mania/hypomania respectively). The depressive aspect of bipolar disorder is often overlooked, possibly due to its less dramatic nature, despite its significant impact on the lives of those affected. Bipolar depression (BPAD-DP) is associated with a twenty fold increased risk of suicide, and typically lasts three to five times as long as a manic or hypomanic episode. Despite this, there has been relatively sparse investigation of treatments for BPAD-DP, with guidelines based primarily on expert judgment rather than clinical trials. In addition a significant proportion of patients with bipolar depression do not respond to the range of commonly used medications. One of the only substantially new treatments developed for unipolar depression in recent years has been the advent of repetitive transcranial magnetic stimulation (rTMS). Repetitive TMS has been evaluated in over 20 trials conducted over the last ten years, but no substantive trials have explored its use in bipolar depression. We propose to do this, conducting a large scale clinical trial. The trial will include the assessment of both high frequency left sided rTMS (as there is clearly the greatest evidence for the effectiveness of this in unipolar depression) and low frequency right sided rTMS (as this there is growing evidence of the effectiveness of this in unipolar depression and we have an excellent pilot study to suggest its potential in BPAD-DP and it has never previously been assessed in a clinical trial exclusively targeting this patient group). Our previous research strongly supports the effectiveness of rTMS paradigms including low frequency right-sided stimulation in unipolar depression and suggests these may have value in BPAD-DP. As BPAD-DP is clearly a clinical problem of significant impact and with limited treatment options, there is a pressing need for the development and definitive testing of novel treatments such as rTMS.

NCT ID: NCT00431522 Completed - Bipolar Disorder Clinical Trials

Valproic Acid Sodium Salt in Bipolar Disorder

Start date: December 2004
Phase: Phase 4
Study type: Interventional

- To determine the total and local gray matter volumes, and N-acetyl aspartate (NAA) levels in patients with bipolar disorders who are within euthimic, depressive or manic/hypomanic period and who are not taking drug; - To investigate the neuroprotective effects of long-term (6 weeks) use of valproate on total and local gray matter volumes and NAA levels. - To measure the brain electrical response to visual and auditory impulses before and after valproate treatment in patients within euthimic, depressive or manic/hypomanic period and who are not taking drug, and to compare the data with each other and with normal groups. - To determine the cognitive functions before and after the valproate treatment in the same patient group, to compare the data with each other and with age- and sex-paired normal controls; - To determine the relationship between these effects of valproate and clinical improvement; - To investigate the relationship between cognitive ability status and electrical activity of brain, to compare this with that in control group; to determine the relationship between the data and brain imaging (MRI/MRS) findings in conjunction with localization

NCT ID: NCT00431184 Completed - Bipolar Disorder Clinical Trials

Effects of Pentazocine Versus Lorazepam on Manic Symptoms

Start date: January 2007
Phase: Phase 2
Study type: Interventional

Pilot data indicates that pentazocine decreases manic symptoms in hospitalized individuals. To follow up these initial findings, we plan to conduct a larger, more rigorous, double-blind study. We will examine whether pentazocine, an agent with kappa-opiate activity, decreases manic symptoms.

NCT ID: NCT00422214 Completed - Depression, Bipolar Clinical Trials

Phase III/Seroquel SR Bipolar Depression Monotherapy - US

Start date: December 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.