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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Anxiety Disorders

Treatments: Drug: SSR149415; Drug: Placebo; Drug: Paroxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00374166

DFI5880

Details and patient eligibility

About

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

Enrollment: 325 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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325 participants in 4 patient groups, including a placebo group

SSR149415 - 250 mg

Experimental group

Description:

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

Treatment:

Drug: SSR149415

SSR149415 - 100 mg

Experimental group

Description:

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

Treatment:

Drug: SSR149415

Drug: Placebo

Paroxetine

Active Comparator group

Description:

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

Treatment:

Drug: Paroxetine

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Placebo for a maximum of 9 weeks

Treatment:

Drug: Placebo