Advertisement

Topics

A Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD)

2014-08-27 03:13:09 | BioPortfolio

Summary

This is a multi-center, placebo-controlled, randomized, double-blind, parallel-comparison study to confirm the efficacy of 323U66 Sustained Release (SR) orally administered to patients with MDD (Major Depressive Disorder) at doses level of 150 mg/day and 300 mg/day for 8 weeks based on the decrease in MADRS (Montgomery-Asberg Depression Rating Scale) total score, and to evaluate the safety based on adverse events, clinical laboratory tests and vital signs.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Depressive Disorder

Intervention

323U66 SR 150 mg tablet, 323U66 SR 150 mg placebo tablet

Location

GSK Investigational Site
Kumamoto
Japan
861-8002

Status

Not yet recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:09-0400

Clinical Trials [3147 Associated Clinical Trials listed on BioPortfolio]

Study Of Bupropion SR (323U66) In Patients With Major Depressive Disorder In Japan

This is a study to obtain clinical experience of 323U66 SR for elderly patients with depression in repeat-dose of 323U66 SR up to 300mg/day, and to conduct exploratory investigation on saf...

Study Of 323U66 SR In Major Depressive Disorder

This study was designed to evaluate the efficacy and safety in major depressive disorder patients.

Study In Patients With Depression Not Responding to Selective Serotonin Re-uptake Inhibitors

This study is designed to evaluate the efficacy and safety in depressive patients who did not respond sufficiently to selective serotonin re-uptake inhibitors (SSRI).

A Study to Asses the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken tog...

A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken tog...

PubMed Articles [5826 Associated PubMed Articles listed on BioPortfolio]

A meta-analysis of single-case research on the use of tablet-mediated interventions for persons with ASD.

There is a growing amount of single-case research literature on the benefits of tablet-mediated interventions for individuals with autism spectrum disorder (ASD). With the development of tablet-based ...

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Intranasal Human Abuse Potential Study of Oxycodone ARIR, a Novel, Immediate-Release, Abuse-Deterrent Formulation.

Prescription opioid abuse continues to be a public health concern. Oxycodone ARIR is an immediate-release (IR) oxycodone tablet composed of multiple overlapping barriers that deter manipulation of the...

A mechanistic study on tablet ejection force and its sensitivity to lubrication for pharmaceutical powders.

Pharmaceutical powders can exhibit markedly different tablet ejection forces. The purpose of this study is to understand the factors leading to the variability of the tablet ejection force and its sen...

Vortioxetine versus placebo in major depressive disorder comorbid with social anxiety disorder.

Major Depressive Disorder (MDD) and Social Anxiety Disorder (SAD) are highly comorbid, yet the combined condition has not been subject to any placebo-controlled treatment trials. This study reports a ...

The Relative Bioavailability, Food Effect, and Drug Interaction With Omeprazole of Momelotinib Tablet Formulation in Healthy Subjects.

Momelotinib is a potent and selective small-molecule inhibitor of JAK1/2 that is under investigation for the treatment of myeloproliferative neoplasms. In a phase 1/2 study in myelofibrosis patients, ...

Medical and Biotech [MESH] Definitions

Products in capsule, tablet or liquid form that provide essential nutrients, such as a vitamin, an essential mineral, a protein, an herb, or similar nutritional substance. (FDA Backgrounder, June 15, 1993, p2)

Finely powdered native hydrous magnesium silicate. It is used as a dusting powder, either alone or with starch or boric acid, for medicinal and toilet preparations. It is also an excipient and filler for pills, tablets, and for dusting tablet molds. (From Merck Index, 11th ed)

Polymers of ETHYLENE OXIDE and water and their ethers. They vary in consistency from liquid to solid, depending on the molecular weight, indicated by a number following the name. They are used as SURFACTANTS, dispersing agents, solvents, ointment and suppository bases, vehicles, and tablet excipients. Some specific groups are lauromagrogols, nonoxynols, octoxynols and poloxamers.

A calcium salt that is used for a variety of purposes including: building materials, as a desiccant, in dentistry as an impression material, cast, or die, and in medicine for immobilizing casts and as a tablet excipient. It exists in various forms and states of hydration. Plaster of Paris is a mixture of powdered and heat-treated gypsum.

An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities. The mood disturbance is prominent and relatively persistent.

More From BioPortfolio on "A Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Psychiatry
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...

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...


Searches Linking to this Trial