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

NCT00822744 | Completed Phase 2 DMC

• 2 other identifiers: DFI105602008-001718-26
• Study Type: interventional
• Target: 527
• Locations: 7 countries
• Sites: 7

Brief 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

Major Depressive Disorder

Keywords

Depression; Major Depressive Episode; Antidepressant

Outcome Measures

Primary Outcomes (1)

• 17-item Hamilton Depression Rating Scale (HAM-D) total score

  The HAM-D consists of 17 items assessing signs and symptoms of depression. All items are scored with a severity rating from 0 (not present) to 2 or 4 (very severe), depending on the item. The minimum and maximum possible scores are 0 and 52, respectively.

  8 weeks (from D-1 (before randomization) up to D56)

Secondary Outcomes (8)

• Montgomery-Asberg Depression Rating Scale (MADRS) total score

  8 weeks (from D-1 (before randomization) up to D56)

• Clinical Global Impression (CGI) scores

  D-1 (before randomization) and D56

• HAM-D depressed mood item score, factor scores and core item score

  8 weeks (from D-1 (before randomization) up to D56)

• Geriatric Depression Scale (GDS) total score

  D-1 (before randomization) and D56

• Sheehan Disability Scale (SDS) total score

  D-1 (before randomization) and D56

Study Arms (5)

SSR411298 10 mg

EXPERIMENTAL

SSR411298 10 mg, one capsule once daily for 8 weeks

Drug: SSR411298

SSR411298 50 mg

EXPERIMENTAL

SSR411298 50 mg, one capsule once daily for 8 weeks

Drug: SSR411298

SSR411298 200 mg

EXPERIMENTAL

SSR411298 200 mg, one capsule once daily for 8 weeks

Drug: SSR411298

Escitalopram 10 mg

ACTIVE COMPARATOR

Escitalopram 10 mg, one capsule once daily for 8 weeks

Drug: Escitalopram

Placebo

PLACEBO COMPARATOR

Placebo (for SSR411298), one capsule once daily for 8 weeks

Drug: Placebo (for SSR411298)

Interventions

SSR411298 DRUG

Form: capsule Route: oral administration with food

SSR411298 10 mg; SSR411298 200 mg; SSR411298 50 mg

Escitalopram DRUG

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

Escitalopram 10 mg

Placebo (for SSR411298) DRUG

Form: capsule Route: oral administration with food

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elderly patient with recurrent Major Depressive Disorder

You may not qualify if:

• Duration of current depressive episode greater than 2 years;
• Mild depression as measured by standard clinical research scales;
• Cognitive disturbance;
• Significant suicide risk;
• Other psychiatric conditions that would obscure the results of the study;
• History of failure to respond to antidepressant treatment.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (7)

Sanofi-Aventis Administrative Office

Santiago, Chile

Location

Sanofi-Aventis Administrative Office

México, Mexico

Location

Sanofi-Aventis Administrative Office

Bucharest, Romania

Location

Sanofi-Aventis Administrative Office

Moscow, Russia

Location

Sanofi-Aventis Administrative Office

Brastislava, Slovakia

Location

Sanofi-Aventis Administrative Office

Midrand, South Africa

Location

Sanofi-Aventis Administrative Office

Kiev, Ukraine

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: December 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 15, 2013

Record last verified: 2013-03

Locations

CL (1); SL (1); ME (1); ZA (1); UA (1); RU (1); RO (1)