Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders
Bipolar DisordersMetabolic ComplicationThe primary goal of this study is to investigate metabolic changes and maintaining efficacy in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.
Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
Bipolar DepressionThe purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.
Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride
Bipolar DepressionThis study is designed to assess the use of pramipexole dihydrochloride and quetiapine (Seroquel) XR as combination therapy for bipolar depression. The proposed benefit of the combination therapy investigated in this study is improved treatment of bipolar depression.
Oral Uridine for Treatment of Bipolar Depression in Adolescents
Bipolar DisorderThe purpose of the study is to see if the investigational medication uridine reduces depression symptoms in adolescents with bipolar disorder. Uridine is a naturally occurring chemical that is made by the human liver. Uridine is part of a family of compounds called pyrimidines, and is normally involved in many of the body's processes such as the use of energy by cells. Uridine is considered experimental, because it has not been approved by the U.S. Food and Drug Administration (FDA) to treat bipolar depression in adolescents. The study will use standard methods of assessing adolescent's mood, such as rating scales and questionnaires. In addition, the study will use Magnetic Resonance Imaging Spectroscopy (MRI/MRS) brain scans to see if levels of certain chemicals in the brain change when adolescents are treated with uridine. These scans use a magnet to create images of the brain, and do not expose patients to radiation.
Illness Management and Recovery (IMR) in Danish Community Mental Health Centres
SchizophreniaBipolar DisorderThe aim of this trial is to evaluate the effectiveness of the Illness Management and Recovery program for people diagnosed with schizophrenia or bipolar disorder in according to their level of functioning.
GSK Drug Single Dose Escalation And Their Effect On Resting Motor Threshold In Healthy Volunteers...
Bipolar DisorderThis is a First Time in Human Study to assess the safety, tolerability, pharmacokinetics and resting motor threshold (rMT) of single doses of GSK drug in healthy volunteers.This will be a 2 part and 2 centre study.Part 1 will be a double-blind, randomized, placebo-controlled, single oral dose, dose-rising, cross-over study in healthy male and female (of non-child bearing potential) volunteers.Subjects will be randomized into cohorts of 10 subjects and cohorts will be recruited until the pre-defined safety or PK stopping limits are reached.Each subject will receive placebo and no more than 4 ascending doses of GSK drug in a randomized sequence on 5 separate study occasions.Each dosing session will take place over 2 days and there will be at least one subject on placebo on each day. There will be only one subject on any new active dose during the first day.Part 2 will be a randomised, double-blind, double-dummy, placebo-controlled, cross-over study to investigate the effect of single doses of GSK drug and lamotrigine on resting motor threshold in healthy male subjects. Subjects will attend the unit a maximum of 4 separate occasions.During each session subjects will receive up to 4 TMS measurements and single doses of either GSK drug, lamotrigine or placebo, in a randomised manner.Up to two doses of GSK drug will be investigated.
Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With...
Bipolar DisorderThe primary objective of this study is to compare the efficacy and tolerability of quetiapine versus divalproex extended-release administered in a rapid oral loading fashion in the treatment of acute episodes of mania or mixed mania in bipolar disorder. Three hypotheses will be tested: Hypothesis 1: treatment ( 3 weeks) of divalproex extended-release is similar to quetiapine in the symptomatic control of mania or mixed mania Hypothesis 2: divalproex extended-release orally loaded may produce significant improvements in symptoms of mania sooner than quetiapine Hypothesis 3: divalproex extended-release may produce significantly less sedation
Open-label Ziprasidone Study for Psychosis Treatment in Adolescents
Schizophreniform DisorderSchizoaffective Disorder4 moreThis open-label study will assess the medication Geodon® (Ziprasidone) in pediatric patients, aged 13-17, diagnosed with psychotic disorder. Eligible adolescents will receive Geodon® for 7 weeks and stay at the NYSPI Children's Day Unit (CDU) during the day. If clinically appropriate, they may also stay at the New York State Psychiatric Institute (NYSPI) Schizophrenia Research Unit (SRU) inpatient facility.
Phase 3 /Seroquel SR Acute Mania Monotherapy - US
Affective PsychosisBipolar6 moreThe 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 Mania for 3 weeks. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
rTMS in the Treatment of Bipolar Depression
Bipolar Affective DisorderBipolar 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.