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

NCT00374166 | Completed Phase 2 DMC

• 1 other identifier: DFI5880
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Anxiety Disorders

Keywords

Anti-anxiety agents; antidepressive agents; controlled clinical trial

Outcome Measures

Primary Outcomes (1)

• Change from baseline to Day 56 in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score.

  8 weeks

Secondary Outcomes (1)

• Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.

  8 weeks

Study Arms (4)

SSR149415 - 250 mg

EXPERIMENTAL

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

Drug: SSR149415

SSR149415 - 100 mg

EXPERIMENTAL

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

Drug: SSR149415; Drug: Placebo

Paroxetine

ACTIVE COMPARATOR

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

Drug: Placebo; Drug: Paroxetine

Placebo

PLACEBO COMPARATOR

Placebo for a maximum of 9 weeks

Drug: Placebo

Interventions

SSR149415 DRUG

Oral administration (capsules of 50 and 100 mg)

SSR149415 - 100 mg; SSR149415 - 250 mg

Placebo DRUG

Oral administration (capsules)

Paroxetine; Placebo; SSR149415 - 100 mg

Paroxetine DRUG

Oral administration (capsules)

Paroxetine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

Related Publications (1)

• Griebel G, Beeske S, Stahl SM. The vasopressin V(1b) receptor antagonist SSR149415 in the treatment of major depressive and generalized anxiety disorders: results from 4 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry. 2012 Nov;73(11):1403-11. doi: 10.4088/JCP.12m07804. Epub 2012 Oct 16.

  PMID: 23146246 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

1-(5-chloro-1-((2,4-dimethoxyphenyl)sulfonyl)-3-(2-methoxyphenyl)-2-oxo-2,3-dihydro-1H-indol-3-yl)-4-hydroxy-N,N-dimethyl-2-pyrrolidinecarboxamide; Paroxetine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Study Start: August 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 25, 2016

Record last verified: 2016-04

Locations

US (1)