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

Primary Purpose

Anxiety Disorders

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

SSR149415

Placebo

Paroxetine

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Anti-anxiety agents, antidepressive agents, controlled clinical trial

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

SSR149415 - 250 mg

SSR149415 - 100 mg

Paroxetine

Placebo

Arm Description

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

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

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

Placebo for a maximum of 9 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00374166

First Posted

September 7, 2006

Last Updated

April 26, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00374166

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety Disorders

Keywords

Anti-anxiety agents, antidepressive agents, controlled clinical trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

325 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SSR149415 - 250 mg

Arm Type

Experimental

Arm Description

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

Arm Title

SSR149415 - 100 mg

Arm Type

Experimental

Arm 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

Arm Title

Paroxetine

Arm Type

Active Comparator

Arm 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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo for a maximum of 9 weeks

Intervention Type

Drug

Intervention Name(s)

SSR149415

Intervention Description

Oral administration (capsules of 50 and 100 mg)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral administration (capsules)

Intervention Type

Drug

Intervention Name(s)

Paroxetine

Intervention Description

Oral administration (capsules)

Primary Outcome Measure Information:

Title

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Bridgewater

State/Province

New Jersey

ZIP/Postal Code

08807

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23146246

Citation

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.

Results Reference

derived

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

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