An Eight-Week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00531622
First received: September 18, 2007
Last updated: February 13, 2009
Last verified: February 2009
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Purpose
The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: saredutant (SR48968) Drug: escitalopram Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | An Eight-Week, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Saredutant 100 mg Once Daily in Combination With Escitalopram 10 mg Once Daily in Patients With Major Depressive Disorder |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Change from baseline in Hamilton Depression Rating Scale total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in the Changes in Sexual Functioning Questionnaire total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Change from baseline in the Clinical Global Impression severity of illness score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 615 |
| Study Start Date: | September 2007 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group 1 |
Drug: saredutant (SR48968)
oral administration
Drug: escitalopram
oral administration
|
| Active Comparator: Group 2 |
Drug: escitalopram
oral administration
|
| Placebo Comparator: Group 3 |
Drug: placebo
oral administration
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Outpatients with recurrent Major Depressive Disorder
Exclusion Criteria:
- Symptoms of current depressive episode for less than 30 days or more than 2 years
- Mild depression, as measured by standard clinical research scales
- Significant suicide risk
- Lack of sexual activity (including masturbation)
- Other psychiatric conditions that would obscure the results of the study
- History of failure to respond to antidepressant treatment
- Pregnancy or breast-feeding
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531622
Locations
| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Argentina | |
| Sanofi-Aventis Administrative Office | |
| Buenos Aires, Argentina | |
| Finland | |
| Sanofi-Aventis Administrative Office | |
| Helsinki, Finland | |
| France | |
| Sanofi-Aventis Administrative Office | |
| Paris, France | |
| Mexico | |
| Sanofi-Aventis Administrative Office | |
| Mexico, Mexico | |
| Sweden | |
| Sanofi-Aventis Administrative Office | |
| Bromma, Sweden | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD | Sanofi |
More Information
Additional Information:
No publications provided
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00531622 History of Changes |
| Other Study ID Numbers: | EFC10290, EudraCT 2007-003159-36 |
| Study First Received: | September 18, 2007 |
| Last Updated: | February 13, 2009 |
| Health Authority: | United States: Food and Drug Administration Mexico: Ministry of Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Sanofi:
|
Depression Major Depressive Episode Antidepressant |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 21, 2013