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An Eight-week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Generalized Anxiety Disorder | Clinical Trials | Clareo Health

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An Eight-week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Generalized Anxiety Disorder

An Eight-week, Multicenter, Double-blind, Placebo- and Paroxetine-controlled Study Evaluating the Efficacy and Tolerability of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) in Outpatients With Generalized Anxiety Disorder

NCT00374166•Sanofi

View on ClinicalTrials.gov

Summary

The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and 100 mg twice daily) compared to placebo and paroxetine 20 mg once daily in outpatients with generalized anxiety disorder

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of generalized anxiety disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI) General Anxiety Disorder (GAD) Plus Module.

Exclusion Criteria

•Total score of less than 22 on the (Hamilton Anxiety rating scale)HAM-A.
•Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 17.
•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.

Locations (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Key Dates

Start Date

August 1, 2006

Primary Completion Date

February 1, 2008

Completion Date

February 1, 2008

Last Updated

May 25, 2016

Enrollment

325

ACTUAL participants

Conditions

Anxiety Disorders

Interventions

SSR149415

DRUG

Placebo

DRUG

Paroxetine

DRUG

In Vivo Exposure vs. Videochat-Based Vicarious Exposure

NCT07432945

AnxietyAnxiety Disorders

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RECRUITINGNA

Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

NCT06661460

ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)Specific Phobia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Eight-week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Generalized Anxiety Disorder

Inclusion Criteria

Exclusion Criteria

In Vivo Exposure vs. Videochat-Based Vicarious Exposure

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