A Study of SR58611A in the Prevention of Depression Relapse in Patients With Major Depressive Disorder (CALYPSO)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00345098
First received: June 26, 2006
Last updated: March 10, 2009
Last verified: March 2009
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Purpose
The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of depressive symptoms in patients with major depressive disorder. Relapse will be assessed using the MADRS scale.Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with SR58611A are randomized to continue SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional treatment. The secondary objective is to evaluate the safety of SR58611A in patients with MDD.
| Condition | Intervention | Phase |
|---|---|---|
|
Depressive Disorder Major Depression |
Drug: SR58611A |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Multi-Center, Multinational, Randomized Withdrawal Study Evaluating the Efficacy and Safety of SR58611A (350mg q12) Versus Placebo in the Prevention of Depression Relapse up to 1 Year in Patients With Major Depressive Disorder Improved After 12 Weeks of Open Treatment With SR58611A (350mg q12) |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- The primary outcome measure is the time to relapse of depressive symptoms (in days) during the double-blind study phase.
Secondary Outcome Measures:
- Change in Clinical Global Impression Severity score. Change in MADRS total score. Change in HAM-A total score
| Enrollment: | 704 |
| Study Start Date: | May 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients diagnosed with Major Depressive Disorder, Recurrent according to DSM-IV-TR criteria Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) and assessed with the Mini International Neuropsychiatric Interview (MINI)
- Total score on the Montgomery and Asberg Depression Rating Scale (MADRS) > 28
- At W12 (V7), patients will be randomized into the double-blind treatment phase if they have MADRS total score < 12
Exclusion Criteria:
- Patients with a significant risk of suicide.
- Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset.
- Patients with a current depressive episode secondary to a general medical disorder.
- Patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder.
- Patients with severe or unstable concomitant medical conditions
- Patients with clinically significant abnormal laboratory value at screening
- The investigator will evaluate whether there are other reasons why a patient may not participate
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345098
Locations
| Argentina | |
| Sanofi-Aventis Administrative Office | |
| Buenos Aires, Argentina | |
| Bulgaria | |
| Sanofi-Aventis Administrative Office | |
| Sofia, Bulgaria | |
| Croatia | |
| Sanofi-Aventis Administrative Office | |
| Zagreb, Croatia | |
| Czech Republic | |
| Sanofi-Aventis Administrative Office | |
| Praha, Czech Republic | |
| Finland | |
| Sanofi-Aventis Administrative Office | |
| Helsinki, Finland | |
| France | |
| Sanofi-Aventis Administrative Office | |
| Paris, France | |
| Mexico | |
| Sanofi-Aventis Administrative Office | |
| Mexico, Mexico | |
| Poland | |
| Sanofi-Aventis Administrative Office | |
| Warszawa, Poland | |
| Romania | |
| Sanofi-Aventis Administrative Office | |
| Bucuresti, Romania | |
| Russian Federation | |
| Sanofi-Aventis Administrative Office | |
| Moscow, Russian Federation | |
| Serbia | |
| Sanofi-Aventis Administrative Office | |
| Belgrade, Serbia | |
| Slovakia | |
| Sanofi-Aventis Administrative Office | |
| Bratislava, Slovakia | |
| South Africa | |
| Sanofi-Aventis Administrative Office | |
| Midrand, South Africa | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD CSD | Sanofi |
More Information
Additional Information:
No publications provided
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00345098 History of Changes |
| Other Study ID Numbers: | LTE5376, EudraCT 2005-004006-81 |
| Study First Received: | June 26, 2006 |
| Last Updated: | March 10, 2009 |
| Health Authority: | Finland: Finnish Medicines Agency Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Slovakia: State Institute for Drug Control |
Keywords provided by Sanofi:
|
Depression, Antidepressive agents Clinical Trial Phase III Multicenter study |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Antidepressive Agents SR 58611A Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013