An eight-week, double-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. - NA

• Conditions: Generalized Anxiety Disorder (GAD); MedDRA version: 8.0Level: LLTClassification code 10018105

• Registration Number: EUCTR2005-003181-41-AT
• Lead Sponsor: Sanofi-Synthelabo Recherche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-07
• Last Update Posted: 27 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

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) >= 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.
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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

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.
Patients having a current score of >5 on the suicidal thoughts item of the MADRS at screening or
baseline and/or are assessed to have a moderate to high current risk for suicide according to the
MINI.
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.
Patients with a lifetime history according to the MINI of: Bipolar disorders, Psychotic disorders,
Antisocial Personality Disorder.
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.
Patients with a history of non-response to treatment with paroxetine.
Hypersensitivity to paroxetine.
Patients who have used the following prior to screening: any antipsychotic within 3 months, any
antidepressant within 4 weeks, any continuous use of anxiolytic (e.g., benzodiazepines,
buspirone) or hypnotic within 2 weeks, any mood-stabilizer (lithium, anticonvulsants) within 4
weeks. Treatment with electroconvulsive therapy (ECT) or rapid Transcranial Magnetic
Stimulation (rTMS) within 3 months prior to screening.
Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within
3 months prior to screening.
General and Medical Exclusion criteria :
Patients with severe or unstable concomitant medical conditions (cardiovascular, neurologic,
gastrointestinal, hepatic, renal, endocrinologic, rheumatologic).
History of seizures other than a single childhood febrile seizure.
Patients with clinically significant ECG findings at screening.
Females who are pregnant or lactating.
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.
Any subject who has previously participated in a clinical trial with SR58611A.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of a fixed dose of SR58611A (350 mg q12) compared to placebo in patients with GAD using paroxetine (20 mg q24) as positive control.;Secondary Objective: To evaluate the tolerability and safety of SR58611A in patients with GAD.;Primary end point(s): Efficacy evaluated at V7 (D56).<br>Primary criterion : change from baseline in 14-item Hamilton Anxiety Rating Scale (HAM-A) total score.