An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression
Summary
The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C) in patients with depression.
The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with depression.
The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy of saredutant on disability and quality of life in patients with depression, and to evaluate blood levels of saredutant.
Description
The study is a multicenter, US, randomized, parallel-group, double blind, placebo and paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a 1-week, placebo, single-blind period and Segment B is an 8-week, double blind period. Patients completing Segment B may be eligible for enrollment into Segment C, a 44-week, double blind extension. All randomized patients must complete a post-study telephone visit and a post-study office visit 3 days and 1 week, respectively, after intake of the last dose of study medication.
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
Saredutant succinate (SR48968C)
Location
Administrative Office
Bridgewater
New Jersey
United States
08807
Status
Completed
Source
Sanofi-Aventis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00250601
- Information obtained from ClinicalTrials.gov on March 12, 2012
Medical and Biotech [MESH] Definitions
Succinate-coa Ligases
Enzymes that catalyze the first step leading to the oxidation of succinic acid by the reversible formation of succinyl-CoA from succinate and CoA with the concomitant cleavage of ATP to ADP (EC 6.2.1.5) or GTP to GDP (EC 6.2.1.4) and orthophosphate. Itaconate can act instead of succinate and ITP instead of GTP.EC 6.2.1.-.
Bipolar Disorder
A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.
Depressive Disorder
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.
Trazodone
A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)
Succinate-semialdehyde Dehydrogenase
An enzyme that plays a role in the GLUTAMATE and butanoate metabolism pathways by catalyzing the oxidation of succinate semialdehyde to SUCCINATE using NAD+ as a coenzyme. Deficiency of this enzyme, causes 4-hydroxybutyricaciduria, a rare inborn error in the metabolism of the neurotransmitter 4-aminobutyric acid (GABA).
Clinical Trials
An Eight-Week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression
The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C) in patients with depression. The primary objective is to evaluate the efficacy of a 100 mg dose...
An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression
The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C) in patients with depression. The primary objective is to evaluate the efficacy of a 100 mg dose...
An Eight-Week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression
The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C) in patients with depression. The primary objective is to evaluate the efficacy of a 100 mg dose...
The purpose of the study is to evaluate the long-term efficacy and safety of saredutant in patients with depression. The primary objective is to evaluate the efficacy and safety of saredut...
The purpose of the study is to evaluate the long-term safety of saredutant (or SR48968C) in adult and elderly patients with depression.The primary objective is to evaluate the long-term sa...
PubMed Articles
These experiments were undertaken to assess the mechanisms underlying the antidepressant-like effects of the neurokinin-2 (NK2) receptor antagonist saredutant (SR48968) in rats tested in the forced sw...
Intracerebroventricular (i.c.v.) or intraperitoneal (IP) administration of saredutant (SR48968), an NK2 receptor antagonist, produces anxiolytic-like effects in rodents in a number of animal models of...
Alcohol-use disorder severity predicts first-incidence of depressive disorders.
BACKGROUND: Previous studies suggest that alcohol-use disorder severity, defined by the number of criteria met, provides a more informative phenotype than dichotomized DSM-IV diagnostic measures of al...
YWHAE is a gene encoding 14-3-3epsilon, which is highly conserved across species, from bacteria to humans, and binds to phosphoserine/phosphothreonine motifs in a sequence-specific manner. YWHAE has b...
ABSTRACT: BACKGROUND: Depressive disorder is often chronic and recurrent, and results in a heavy psychosocial burden on the families of patients with this disorder. This study aims to examine the effe...
