An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder

NCT00390533 | Completed Phase 3 DMC

• 2 other identifiers: EFC5582SR48968
• Study Type: interventional
• Target: 428
• Locations: 2 countries
• Sites: 2

Brief Summary

The primary objective is to evaluate the efficacy of two fixed doses (100 mg and 30 mg once daily) of saredutant compared to placebo in patients with generalized anxiety disorder. The secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.

Conditions

Generalized Anxiety

Keywords

Anxiety; clinical trials

Outcome Measures

Primary Outcomes (1)

• Change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.

  56 days

Secondary Outcomes (1)

• Change from baseline to Day 56 of treatment in the Clinical Global Impression Severity of Illness score.

  56 days

Study Arms (3)

Saredutant 30 mg

EXPERIMENTAL

Saredutant 30 mg once daily for a maximum of 8 weeks

Drug: Saredutant

Saredutant 100 mg

EXPERIMENTAL

Saredutant 100 mg once daily for a maximum of 8 weeks

Drug: Saredutant

Placebo

PLACEBO COMPARATOR

Placebo for saredutant once daily for one week during the screening phase and for a maximum of 8 weeks during the acute phase

Drug: Placebo

Interventions

Saredutant DRUG

oral administration (capsules)

Saredutant 100 mg; Saredutant 30 mg

Placebo DRUG

oral administration (capsules)

Placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosis of generalized anxiety disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) Plus Generalized Anxiety Disorder module.

You may not qualify if:

• Total score of less than 22 on the HAM-A.
• Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 18.
• Patients with a current history (within 6 months) of major depressive disorder or history or presence of bipolar disorders or psychotic disorders.
• Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
• Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, antidepressants including Monoamine Oxidase Inhibitors (MAOIs) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use.
• The investigator will evaluate whether there are other reasons why a patient may not participate.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis Administrative Office

Macquarie Park, Australia

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Interventions

SR 48968

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2006
• First Posted: October 20, 2006
• Study Start: September 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 24, 2016

Record last verified: 2016-04

Locations

AU (1); US (1)