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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00252343
Other study ID # EFC5892
Secondary ID
Status Completed
Phase Phase 3
First received November 10, 2005
Last updated March 10, 2009
Start date September 2005
Est. completion date February 2007

Study information

Verified date March 2009
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy of a fixed dose of SR58611A (350mg q12) compared to placebo in patients with GeneralizedAnxiety Disorder (GAD) using escitalopram (10 mg qd) as positive control. To evaluate the tolerability and safety of SR58611A in patients with GAD.


Description:

The current study will be conducted to evaluate the efficacy, safety, and tolerability of SR58611A (350 mg q12) compared to placebo in patients with generalized anxiety disorder (GAD), using escitalopram (10 mg qd) as a positive control. This is an 8-week, double-blind, randomized, 3-parallel-group, placebo- and escitalopram-controlled, study.A 1-week, placebo, single-blind period precedes the 8-week randomized treatment period. A Safety Follow up Visit (Segment C) is scheduled 1 week after the acute treatmentperiod (Segment B) or early termination. This trial is designed to compare the efficacy, safety, and tolerability of SR58611A to placebo. In this study, escitalopram, a selective serotonin reuptake inhibitor (SSRI) antidepressant, is used as a positive control and has been chosen as the comparator agentas it is approved for treatment of GAD at a dose of 10 mg once daily.


Recruitment information / eligibility

Status Completed
Enrollment 360
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Main inclusion criteria:

1. Out-patients, 18 year and older.

2. Generalized Anxiety Disorder (GAD) according toDSM-IV-TR criteria / MINI.

3. Minimum total score of 20 on the 14-item HamiltonAnxiety Rating Scale (HAM-A)

Exclusion Criteria:

Main exclusion criteria:

1. Patients with a diagnosis of Major Depressive Disorder within 6 months of study entry.

2. Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or higher

3. Patients who are assessed to have a moderate to high current risk for suicide according to the MINI, or at imminent risk for a suicide attempt

4. Patients with other current anxiety disorder (within 6 months) assessed with the MINI:- Agoraphobia, social phobia,- Panic disorder,- Obsessive compulsive disorder,- Post-traumatic stress disorder, acute stress disorder.

5. Patients with a lifetime history according to the MINI of:- Bipolar disorders,- Psychotic disorders,- Antisocial Personality Disorder.

6. Patients with a current history according to the MINI of:- Anorexia nervosa or bulimia nervosa in the past 6 months,- Alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.

7. Patients who have received non-pharmacologic, somatic treatments for psychiatric disease

8. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
SR58611A


Locations

Country Name City State
United States Sanofi-Aventis 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 14-item Hamilton Anxiety Rating Scale (HAM-A) total score
Secondary Change from baseline in Clinical Global Impression (CGI)
Secondary Severity of Illness score
Secondary Safety assessments
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