NCT00361491|CompletedPhase 2

An Eight-Week Study Evaluating the Efficacy of Two Fixed Doses (250 mg Twice Daily and 100 mg Twice Daily) of SSR149415 in Patients With Major Depressive Disorder

LENA

An Eight-Week, Multicenter, Double-Blind, Placebo- and Paroxetine-Controlled Study Evaluating the Efficacy, and Tolerability of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) in Patients With Major Depressive Disorder

Sanofi ClinicalTrials.gov

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1 other identifier

DFI5879

Study Type

interventional

Target

324

Locations

7 countries

Sites

Timeline

RegisteredAug 2006

StartedAug 2006

CompletionSep 2007

Brief Summary

The purpose of the study is to evaluate the efficacy of SSR149415 in the treatment of Major Depressive Disorder, defined as a change from baseline to visit 7 in the Hamilton Depression Rating Scale. To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate plasma concentrations of SSR149415.

Trial Health

On Track

Trial Health Score

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

Enrollment

324

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Aug 2006

Shorter than P25 for phase_2

Geographic Reach

7 countries

7 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

August 1, 2006

Completed

6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed

Last Updated

January 16, 2009

Status Verified

January 1, 2009

Enrollment Period

1.1 years

First QC Date

August 7, 2006

Last Update Submit

January 15, 2009

Conditions

Depressive Disorder

Keywords

Depressionantidepressive disorderscontrolled clinical trial

Outcome Measures

Primary Outcomes (1)

The primary efficacy endpoint is the change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score

Secondary Outcomes (1)

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

Interventions

SSR149415DRUG

Eligibility Criteria

Age18 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Diagnosis of major depressive disorder, recurrent, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI)

You may not qualify if:

Total score of less than 24 on the MADRS.
HAM-D total score less than 18.
Duration of the current depressive episode less than 1 month or greater than 2 years.
Patients with a history or presence of bipolar disorders or psychotic disorders.
Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, MAOIs within 2 weeks, other antidepressants, or mood-stabilizer (lithium, anticonvulsants) within 1 week.
The investigator will evaluate whether there are other reasons why a patient may not participate

Contact the study team to confirm eligibility.