A Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD)
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
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01138007
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:13:09-0400
Clinical Trials
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).
Role of Pentoxifylline as an Adjuvant Therapy for Adult Patients With Major Depressive Disorder
This study aimed to evaluate the therapeutic benefits of pentoxifylline (PTX) in treatment of adult patients with MDD as it has anti-inflammatory and phosphodiastrase inhibition activities...
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
The SQ tree SLIT-tablet (ALK) is developed for treatment of tree pollen induced allergic rhinoconjunctivitis (ARC).
Probing the early stages of tablet disintegration by stress relaxation measurement.
Rapid tablet disintegration is a requirement for the efficient dissolution of the active pharmaceutical ingredient (API) from immediate release tablets. From the mechanistic viewpoint, tablet disinteg...
Effectiveness of antiretroviral therapy in the single-tablet regimen era.
To evaluate the effectiveness of antiretroviral therapy and the associated factors according to the type of regimen used: Single Tablet Regimen or Multiple Tablet Regimen.
Mobile devices such as tablet computers have become widely available as mainstream devices and are also used in some schools, but there is an absence of robust information regarding the efficacy of an...
In silico predictions of tablet density using a quantitative structure-property relationship model.
The purpose of this study was to explore the potential of a quantitative structure-property relationship (QSPR) model to predict tablet density. First, we calculated 3381 molecular descriptors for 81 ...
Medical and Biotech [MESH] Definitions
Dietary Supplements
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)
Talc
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)
Polyethylene Glycols
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.
Calcium Sulfate
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.
Bipolar Disorder
A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.
