Sleep Satisfaction and Psychomotor Performance of Adults
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep Disorders
Intervention: ZOLPIDEM (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Medical Affairs, Study Director, Affiliation: Sanofi-Aventis
Overall contact:
For site information, send an email with site number to, Email: PublicRegistryGMA@sanofi-aventis.com
Summary
Primary Objective:
To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration
Secondary Objective:
To assess Psychomotor Performance before and after Zolpidem CR (Ambien CR) administration
Clinical Details
Official title: Sleep Satisfaction and PsychoMOtor PeRFormance of Adults Outpatients PrEvious and POst Zolpidem CR
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire)
Secondary outcome: Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale)
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Patients consulting Psychiatrists (private or hospital) -whatever the reason for
consulting- who present with chronic primary insomnia from the DSM IV (Diagnostic and
Statistical Manual - Revision 4).
- Accepting to participate in the study and signing informed consent
Exclusion criteria:
- Pregnancy or breastfeeding.
- Current severe neuropsychiatric disorder (i. e. psychosis, obsessive compulsive
disorder, major depression, dementia of Alzheimer or vascular type) according to DSM
IV criteria.
- History of substance abuse or dependence (including alcohol) within the past year.
- Hypersensitivity to zolpidem or its excipients.
- Severe hepatic insufficiency
- Severe and/or acute respiratory insufficiency
- Myasthenia gravis.
- OTC (Over The Counter) sleep remedies or prescription sleep medications within 2
weeks or 5 half-life before screening.
- Severe medical illness.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Locations and Contacts
For site information, send an email with site number to, Email: PublicRegistryGMA@sanofi-aventis.com
Sanofi-Aventis Investigational Site Number 10, Buenos Aires, Argentina; Recruiting
Sanofi-Aventis Investigational Site Number 1, C.a.b.a., Argentina; Recruiting
Sanofi-Aventis Investigational Site Number 6, C.a.b.a., Argentina; Recruiting
Sanofi-Aventis Investigational Site Number 4, C.a.b.a., Argentina; Not yet recruiting
Sanofi-Aventis Investigational Site Number 3, La Plata, Argentina; Recruiting
Additional Information
Starting date: March 2010
Last updated: September 10, 2010
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