A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule

2014-08-27 03:16:28 | BioPortfolio


This is a regulatory-required non-interventional pharmacovigilance study exploring the safety profile of ziprasidone HCL monohydrate 20mg, 40mg, 60mg, 80mg in the real world patient population, thus, safety (and/or efficacy) signals will be checked at every visit during the contracted study period until the maximum study end date, per the protocol, of April 2010.


All patients diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features will be included in the study.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Bipolar Disorder







Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:16:28-0400

Clinical Trials [1051 Associated Clinical Trials listed on BioPortfolio]

Ziprasidone in Pediatric Bipolar Disorder

This is a 6 week, open-label, blinded-rater, randomized, controlled, pilot study designed to determine the dosing, safety and efficacy of ziprasidone in the treatment of pediatric bipolar ...

Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression. Ziprasidon...

Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Disorder

The objective of this study is to compare the safety and effectiveness of Ziprasidone in the treatment of mania in children and adolescents with Bipolar disorder over 8 weeks. This is an e...

Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder

This study proposes to examine the potential safety and efficacy of ziprasidone for patients with anxiety and bipolar disorder on anxiety outcomes, bipolar symptoms, and on measures of qua...

Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with Bipolar l Disorder (Manic or M...

PubMed Articles [4662 Associated PubMed Articles listed on BioPortfolio]

Cortical Volume and Thickness Across Bipolar Disorder Subtypes in Adolescents: A Preliminary Study.

Neuroimaging studies of adults with bipolar disorder (BD) have identified several BD subtype distinctions, including greater deficits in prefrontal gray matter volumes in BD-I (bipolar I disorder) com...

Is suicide risk a predictor of diagnosis conversion to bipolar disorder?

To assess predictors of the diagnosis of bipolar disorder is important since it is known that the early diagnosis is associated with a better response to the treatment. Thus, the aim of this systemati...

Testing a Clinical Staging Model for Bipolar Disorder using Longitudinal Life Chart Data.

Bipolar disorder has a wide range of clinical manifestations which may progress over time. The aim of this study was to test the applicability of a clinical staging model for bipolar disorder and to g...

Association of Neuroimaging Measures of Emotion Processing and Regulation Neural Circuitries With Symptoms of Bipolar Disorder in Offspring at Risk for Bipolar Disorder.

Bipolar disorder (BD) is difficult to distinguish from other psychiatric disorders. Neuroimaging studies can identify objective markers of BD risk.

Attentional engagement increases inferior frontal gyrus activity and mutes limbic activity in pediatric bipolar disorder: Meta-analyses of fMRI studies.

Attentional deficit has been shown to exist in adult and pediatric bipolar disorder across the life span. Given that emotional dysregulation is central to bipolar disorder, this study hypothesizes tha...

Medical and Biotech [MESH] Definitions

A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.

A dibenzothiazepine and ANTIPSYCHOTIC AGENT that targets the SEROTONIN 5-HT2 RECEPTOR; HISTAMINE H1 RECEPTOR, adrenergic alpha1 and alpha2 receptors, as well as the DOPAMINE D1 RECEPTOR and DOPAMINE D2 RECEPTOR. It is used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER and DEPRESSIVE DISORDER.

An element in the alkali metals family. It has the atomic symbol Li, atomic number 3, and atomic weight 6.94. Salts of lithium are used in treating BIPOLAR DISORDER.

INTERNEURONS of the vertebrate RETINA containing two processes. They receive inputs from the RETINAL PHOTORECEPTOR CELLS and send outputs to the RETINAL GANGLION CELLS. The bipolar cells also make lateral connections in the retina with the RETINAL HORIZONTAL CELLS and with the AMACRINE CELLS.

A thiazole derivative and atypical ANTIPSYCHOTIC AGENT that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST; SEROTONIN 5-HT2 RECEPTOR ANTAGONIST, serotonin 5-HT7 receptor antagonist, and antagonist of the adrenergic α2A and α2C receptors, as well as a partial SEROTONIN 5-HT1A RECEPTOR AGONIST. It is used in the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER.

More From BioPortfolio on "A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule"

Quick Search


Relevant Topic

Psychiatry is the study of mental disorders and their diagnosis, management and prevention.  Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...

Searches Linking to this Trial