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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00361491

Acronym

LENA

Enrollment

324

Registered

2006-08-08

Start date

2006-08-31

Completion date

2007-09-30

Last updated

2009-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder

Keywords

Depression, antidepressive disorders, controlled clinical trial

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.

Interventions

DRUGSSR149415

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Argentina, Bulgaria, Canada, Chile, Croatia, Mexico, Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026