NCT00535340|TerminatedPhase 3

Study Stopped

reprioritization of indications

An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Generalized Anxiety Disorder

GEMINI

An Eight-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Fixed Dose of SR58611A 350 mg Twice a Day in Elderly Patients With Generalized Anxiety Disorder With an Optional Twenty-Four Week Extension

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC5895EudraCT 2006-004147-33

Study Type

interventional

Target

Locations

5 countries

Sites

Timeline

RegisteredSep 2007

StartedMar 2007

CompletionAug 2007

Brief Summary

The primary objective of this study is to demonstrate the efficacy of SR58611A 350 mg twice a day compared to placebo in elderly patients with Generalized Anxiety Disorder (GAD), as assessed by the 14-item Hamilton Anxiety rating Scale (HAM-A). Secondary objectives are to evaluate the tolerability and safety of SR58611A in elderly patients with GAD, to evaluate the efficacy of SR58611A compared to placebo on disablility and quality of life in elderly patients with GAD and to evaluate the tolerability and safety of 24 weeks of additional treatment with SR58611A in elderly patients with GAD.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Mar 2007

Shorter than P25 for phase_3

Geographic Reach

5 countries

5 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5 months study duration

Study Start

First participant enrolled

March 1, 2007

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed

Last Updated

March 12, 2009

Status Verified

March 1, 2009

Enrollment Period

5 months

First QC Date

September 25, 2007

Last Update Submit

March 10, 2009

Conditions

Anxiety Disorders

Keywords

AnxietyAnti-Anxiety Agents

Outcome Measures

Primary Outcomes (1)

Change from baseline to visit 7 (Day 56) in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score

Secondary Outcomes (2)

Clinical Global Impression (CGI) Severity of Illness Score
Adverse events

Interventions

SR58611ADRUG

Eligibility Criteria

Age60 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients diagnosed with Generalized Anxiety Disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and supported by the Mini International Neuropsychiatric Interview (MINI) plus Generalized Anxiety Disorder module

You may not qualify if:

Minimum total score of less than 22 on the 14-item HAM-A scale
Total score of 18 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS)
Mini-Mental State Examination (MMSE) score of 22 or less
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.