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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00374166
First received: September 7, 2006
Last updated: April 26, 2016
Last verified: April 2016

September 7, 2006
April 26, 2016
August 2006
February 2008   (final data collection date for primary outcome measure)
Change from baseline to Day 56 in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The primary efficacy endpoint is the change from baseline to Day 56 in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score.
Complete list of historical versions of study NCT00374166 on ClinicalTrials.gov Archive Site
Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The main secondary endpoints are the changes from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.
Not Provided
Not Provided
 
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
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Anxiety Disorders
  • Drug: SSR149415
    Oral administration (capsules of 50 and 100 mg)
  • Drug: Placebo
    Oral administration (capsules)
  • Drug: Paroxetine
    Oral administration (capsules)
  • Experimental: SSR149415 - 250 mg
    SSR149415 250 mg, twice daily for a maximum of 8 weeks
    Intervention: Drug: SSR149415
  • Experimental: 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
    Interventions:
    • Drug: SSR149415
    • Drug: Placebo
  • Active Comparator: 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
    Interventions:
    • Drug: Placebo
    • Drug: Paroxetine
  • Placebo Comparator: Placebo
    Placebo for a maximum of 9 weeks
    Intervention: Drug: Placebo
Griebel G, Beeské 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
325
February 2008
February 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00374166
DFI5880
Yes
Not Provided
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP