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

NCT00250653 | Completed Phase 3

• 2 other identifiers: LTS5577Saredutant (SR48968C)
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depressive Disorder

Keywords

depression; antidepressive agents; clinical trial

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the proportion of patients experiencing at least one treatment-emergent adverse event.

Secondary Outcomes (1)

• 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.

Interventions

Saredutant succinate (SR48968C) DRUG

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Depression

Interventions

SR 48968

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 8, 2005
• Study Start: May 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: February 17, 2012

Record last verified: 2012-02

Locations

US (1)