Sleep Satisfaction and Psychomotor Performance of Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01097382
• Date of registration: 31/03/2010
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Sleep Satisfaction and Psychomotor Performance of Adults MORFEO CR
• Scientific title: National, Multicenter, Open Label, Phase IV, Before-after Design Study, in Adult Patients With Primary Insomnia to Evaluate Sleep Satisfaction and Psychomotor Performance After 1 Month of Treatment With Zolpidem CR (Ambien®CR) in 6 Sites in Argentina
• Date of first enrolment: March 2010
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01097382
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Argentina

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Sleep Disorders

Intervention(s)

Drug: ZOLPIDEM

Primary Outcome(s)

Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire) [Time Frame: at Baseline, at V2 (26 +/- 2 days)]

Secondary Outcome(s)

Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale) [Time Frame: at Baseline, at V2 (26 +/- 2 days)]

Secondary ID(s)

ZOLPI_L_04551

U1111-1116-9105

Source(s) of Monetary Support

Please refer to primary and secondary sponsors