Clinical trial NCT00266747: An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Patients With Generalized Anxiety Disorder
Official title: An Eight-Week,Dble-Blind,Placebo-Controlled, Multicenter Study With Paroxetine (20 mg q24) as Positive Control, Evaluating the Efficacy, Safety and Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Outpatients With Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety Disorders
Keywords: Anxiety
Anti-Anxiety Agents
Controlled Clinical Trial
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-12-19
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in patients with generalized anxiety disorder (GAD).The secondary objectives are to evaluate the efficacy of SR58611A on disability and quality of life in patients with GAD and to evaluate safety of SR58611A.

Detailed description: The study is a multicenter, multicountry, randomized, parallel-group, double blind, placebo and paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a 1-week, placebo, single-blind period and Segment B is an 8-week, double blind period. All randomized patients must complete a post-study visit 1 week after intake of the last dose of study medication.

Eligibility criteria: Inclusion Criteria:

* Out-patients, 18 to 65 years of age.
* Patients suffering from generalized anxiety disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) plus GAD Module.
* With a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) ³ 20.
* Having given voluntarily their written informed consent to participate in the study.
* Able to comply with the protocol and follow written and verbal instructions.
* For inclusion into Segment B of the study, patients must fulfill the following criteria:
* All Segment A inclusion criteria.
* Completion of a minimum of 3 and a maximum of 9 days of treatment in Segment A.
* Not "placebo responders" (i.e., improvement £ 20 % on HAM-A total score between V1 and V2)

Exclusion Criteria:

* Patients with a diagnosis of Major Depressive Disorder as defined by DSM-IV-TR within 6 months of study entry.
* Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or higher at screening or baseline visits.
* Patients having a moderate to high current risk for suicide.
* Patients with other current anxiety disorder assessed with the MINI: agoraphobia, social phobia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, acute stress disorder.
* Patients with a lifetime history according to the MINI of: bipolar disorders, psychotic disorders, antisocial personality disorder.
* Patients with severe or unstable concomitant medical conditions according to the Investigator's judgment.
* Females who are pregnant or lactating.
* Female patients of childbearing potential must use an effective method of birth control during the entire study period.
* Patients with positive test for any illicit drug included in the urine drug screen.
* Participation in a clinical trial of an experimental therapy within 3 months prior to screening

Primary outcomes:
measure: The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.
Secondary outcomes:
measure: The main secondary outcomes are the changes from baseline to Day 56 of treatment in the CGI Severity of Illness Score, percentage of patients with HAM-A treatment response and change from baseline in the HAM-A somatic and psychic anxiety factor scores.
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis Administrative Office
city: Vienna
country: Austria
facility: Sanofi-Aventis Administrative Office
city: Tallinn
country: Estonia
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Midrand
country: South Africa
facility: Sanofi-Aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: