NCT00256113|CompletedPhase 3

An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression

An Eight-Week, Multicenter, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety, and Tolerability of One Fixed 100 mg Dose of Saredutant in Patients With Major Depressive Disorder

Sanofi ClinicalTrials.gov

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1 other identifier

EFC5575

Study Type

interventional

Target

467

Locations

8 countries

Sites

Timeline

RegisteredNov 2005

StartedDec 2004

CompletionDec 2006

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

467

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Dec 2004

Geographic Reach

8 countries

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

Study Start

First participant enrolled

December 1, 2004

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2005

Completed

14 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed

Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

November 7, 2005

Last Update Submit

April 18, 2018

Conditions

Depressive Disorder

Keywords

depressionantidepressive agentscontrolled clinical trial

Outcome Measures

Primary Outcomes (1)

The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.

Secondary Outcomes (1)

The main secondary outcomes are the changes from baseline to Day 56 of treatment in the HAM-D depressed mood item, the Montgomery Asberg Depression Rating Scale total, and the Clinical Global Impression Severity of Illness scores.

Interventions

Saredutant succinate (SR48968C)DRUG

Eligibility Criteria

Age18 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

\. Male or female patients.
\. 18 to 64 years of age.
\. Inpatients or outpatients.
\. Written informed consent from the patient and/or legally authorized representative.
\. Able to comply with the protocol and follow written and verbal instructions.
\. Subjects of childbearing potential must have a confirmed negative serum b-hCG test prior to entry into Segment B and must employ an acceptable method of birth control (e.g., oral, depot, or implanted contraceptive method, IUDs, sterilization, barrier methods in conjunction with spermicide).
\. Diagnosis of major depressive disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision criteria and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI), recurrent episode for at least one month prior to the entry.
\. Minimum total score of 22 on the Montgomery-Asberg Depression Rating Scale (MADRS).

You may not qualify if:

\. Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset.
\. The duration of the current depressive episode is greater than 2 years.
\. Patients who are currently suicidal or have a history of a suicide attempt within 3 years prior to entry.
\. Patients whose current depressive episode is secondary to a general medical disorder.
\. Patients with a history or presence of bipolar disorders or psychotic disorders according to the D and L criteria of the MINI.
\. Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
\. Patients with a history of failure to respond to treatment with paroxetine or other antidepressant medications.\*
\. Patients who have used the following prior to entry into Segment B: any antipsychotic within 3 months,-fluoxetine within 35 days, -any monoamine oxidase inhibitor within 21 days, any other antidepressant, anxiolytic, sedative-hypnotic, or mood-stabilizer (lithium, anticonvulsants) within 7 days except permitted concomitant medications.
\. Females who are pregnant or breast-feeding.
\. Severe or unstable cardiovascular, renal, hepatic, respiratory, hematological, endocrinological, neurological, or other somatic disease that might interfere with the evaluation of study medication.
\. History of seizures other than a single childhood febrile seizure.
\. ECG abnormalities of potential clinical significance including a QT interval with Bazett's correction of 500 msec or more at entry.
\. Use of known inducers or potent inhibitors of CYP3A4 within 7 days of entry.
\. Use of drugs with known risk for Torsade de Pointes within 7 days of entry into Segment B.
\. Participation in a clinical trial of an experimental therapy within 30 days prior to entry or prior participation in a clinical trial of saredutant.
+2 more criteria

Contact the study team to confirm eligibility.