An 8-week, double blind, placebo-controlled, multicenter study with paroxetine (20 mg q24) as positive control, evaluating the efficacy and safety of 2 fixed doses of SR58611A (175 mg q12 and 350 mg q12) in outpatients with Generalized Anxiety Disorder. - NA

Phase 1

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

• Registration Number: EUCTR2005-003180-23-CZ
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-11
• Study Completion: 2007-04-19
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

1. Out-patients, 18 to 65 years of age.
2. 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.
3. With a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) = 20.
4. Having given voluntarily their written informed consent to participate in the study.
5. Able to comply with the protocol and follow written and verbal instructions.
6. Completion of a minimum of 3 and a maximum of 9 days of treatment in Segment A.
7. 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

1. Patients with a diagnosis of Major Depressive Disorder as defined by DSM-IV-TR
within 6 months of study entry.
2. Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total
score of 18 or higher at screening (V1, D-7) or baseline (V2, D-1).
3. Patients having a current score of >5 on the suicidal thoughts item of the MADRS
(item 10) at screening or baseline and/or are assessed to have a moderate to high
current risk for suicide according to the MINI (item C > 6).
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 with a history of non-response to treatment with paroxetine (at least
20 mg/day for 4 consecutive weeks).
8. Hypersensitivity to paroxetine.
9. Patients who have used the following prior to screening:
a) any antipsychotic within 3 months,
b) any antidepressant within 4 weeks,
c) any continuous use of anxiolytic (e.g., benzodiazepines, buspirone) or hypnotic
within 2 weeks,
d) any mood-stabilizer (lithium, anticonvulsants) within 4 weeks.
10. Treatment with electroconvulsive therapy (ECT) or rapid Transcranial Magnetic
Stimulation (rTMS) within 3 months prior to screening.
11. Patients who have initiated, stopped, or changed the frequency or nature of
psychotherapy within 3 months prior to screening.
12. Patients with severe or unstable concomitant medical conditions (cardiovascular,
neurologic, gastrointestinal, hepatic, renal, endocrinologic, rheumatologic) according
to the Investigator’s judgment.
13. History of seizures other than a single childhood febrile seizure.
14. Patients with clinically significant ECG findings at screening.
15. Females who are pregnant (i.e., females must have a negative ß-HCG pregnancy test at screening) or lactating.
16. Female patients of childbearing potential (females biologically capable of becoming pregnant) must use an effective method of birth control during the entire study period (i.e., birth control pill, intrauterine device, hormonal injection, sterilization or barrier method plus spermicide).
17. Patients with positive test for any illicit drug included in the urine drug screen at V1 (D-7).
18. Participation in a clinical trial of an experimental therapy within 3 months prior to
screening.
19. 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