A Fifty-two-week Study to Evaluate the Safety of Saredutant in Adult and Elderly Patients With Depression

Depressive Disorder Clinical Trial

Official title:

A Fifty-two-week, Multicenter, Open-label Study Evaluating the Long-term Safety and Tolerability of Saredutant in Adult and Elderly Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250653
• Other study ID #: LTS5577
• Secondary ID: Saredutant (SR48
• Status: Completed
• Phase: Phase 3
• First received: November 7, 2005
• Last updated: February 15, 2012
• Start date: May 2005
• Est. completion date: April 2007

Study information

• Verified date: February 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the long-term safety of saredutant (or SR48968C) in adult and elderly patients with depression.The primary objective is to evaluate the long-term safety and tolerability of a 100 mg dose of saredutant in adult and elderly patients with depression. The secondary objective is to evaluate blood levels of saredutant.

Description:

The study is a multicenter, US, open-label study consisting of two segments (A and B). Segment A is a minimum 1-week (maximum 4-week) screening period and Segment B is a 52-week, open-label period. All treated patients must complete a post-study telephone visit and a post-study office visit 3 days and 1 week, respectively, after intake of the last dose of study medication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients.

• At least 18 years of age.

• Inpatients or outpatients.

• Written informed consent from the patient and/or legally authorized representative.

• Able to comply with the protocol and follow written and verbal instructions.

• Subjects of childbearing potential must have a confirmed negative serum b-hCG test prior to entry into Segment B and must employ an acceptable method of birth control (e.g., oral, depot, or implanted contraceptive method, IUDs, sterilization, barrier methods in conjunction with spermicide).

• Diagnosis of major depressive disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision criteria and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI), recurrent episode for at least one month prior to the entry.

• Minimum total score of 18 on the Hamilton Depression Rating Scale (HAM-D).

Exclusion Criteria:

• Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset.

• The duration of the current depressive episode is greater than 2 years.

• Patients who are currently suicidal or have a history of a suicide attempt within 3 years prior to entry.

• Patients whose current depressive episode is secondary to a general medical disorder.

• Patients with a history or presence of bipolar disorders or psychotic disorders according to the D and L criteria of the MINI.

• Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.

• Patients with a history of failure to respond to treatment with paroxetine or other antidepressant medications.

• Patients who have used the following prior to entry into Segment B: fluoxetine within 28 days, any monoamine oxidase inhibitor within 21 days, any other antidepressant, anxiolytic, sedative-hypnotic, or mood-stabilizer (lithium, anticonvulsants) within 7 days except permitted concomitant medications.

• Females who are pregnant or breast-feeding.

• Severe or unstable cardiovascular, renal, hepatic, respiratory, hematological, endocrinological, neurological, or other somatic disease that might interfere with the evaluation of study medication.

• History of seizures other than a single childhood febrile seizure.

• ECG abnormalities of potential clinical significance including a QT interval with Bazett's correction of 500 msec or more at entry.

• Use of known inducers or potent inhibitors of CYP3A4 within 7 days of entry.

• Use of drugs with known risk for Torsade de Pointes within 7 days of entry into Segment B.

• Participation in a clinical trial of an experimental therapy within 30 days prior to entry or prior participation in a clinical trial of saredutant.

• Patients with a positive HbsAg or anti-HCV antibody test at screening.

• Patients with any of the following at screening: ALT >2 times the upper limit of the normal range (XULN), AST >2XULN, GGT >3XULN, total or conjugated bilirubin >ULN

• Elderly patients with a Mini-Mental State Examination total of score of <25.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Saredutant succinate (SR48968C)

Locations

Country	Name	City	State
United States	Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the proportion of patients experiencing at least one treatment-emergent adverse event.
Secondary	The main secondary outcomes are incidences of potentially clinically significant abnormalities and the changes from baseline in the values for clinical laboratories, vital signs, and electrocardiogram parameters.