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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-02-29

Brief Summary

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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

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Detailed Description

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Conditions

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Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SSR149415 - 250 mg

SSR149415 250 mg, twice daily for a maximum of 8 weeks

Group Type EXPERIMENTAL

SSR149415

Intervention Type DRUG

Oral administration (capsules of 50 and 100 mg)

SSR149415 - 100 mg

SSR149415 100 mg and additional placebo capsules in order that all patients are being administered three capsules twice daily for a maximum of 8 weeks

Group Type EXPERIMENTAL

SSR149415

Intervention Type DRUG

Oral administration (capsules of 50 and 100 mg)

Placebo

Intervention Type DRUG

Oral administration (capsules)

Paroxetine

Paroxetine 20 mg and additional placebo capsules in order that all patients are being administered three capsules twice daily for a maximum of 8 weeks

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration (capsules)

Paroxetine

Intervention Type DRUG

Oral administration (capsules)

Placebo

Placebo for a maximum of 9 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration (capsules)

Interventions

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SSR149415

Oral administration (capsules of 50 and 100 mg)

Intervention Type DRUG

Placebo

Oral administration (capsules)

Intervention Type DRUG

Paroxetine

Oral administration (capsules)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No