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An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients

NCT00822744 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 527

Last updated 2013-03-15

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the efficacy of 3 fixed doses of SSR411298 (10, 50 or 200 mg daily) compared to placebo, in elderly patients with Major Depressive Disorder (MDD), based on the 17-item Hamilton Depression Rating Scale.

Secondary objectives are:

* To evaluate the tolerability and safety of an 8-week treatment with SSR411298 versus placebo in elderly patients with MDD.
* To evaluate the effect of SSR411298 on disability, anxiety, cognitive function, sleep, pain and somatic symptoms related to depression, and bone markers.
* To assess SSR411298 plasma concentrations.
* To assess plasma endocannabinoid concentrations.

Conditions

Interventions

DRUG

SSR411298

Form: capsule Route: oral administration with food

DRUG

Escitalopram

Form: capsule (commercial escitalopram tablets were encapsulated within opaque capsules) Route: oral administration with food

DRUG

Placebo (for SSR411298)

Form: capsule Route: oral administration with food

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Chile
  • Mexico
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00822744 on ClinicalTrials.gov