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OpenTrials
Completed

NCT Number: NCT01097382

Sleep Satisfaction and Psychomotor Performance of Adults

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

Completed

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Key information

Conditions

Sleep Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site Number 10, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

zolpidem

Drug

Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily

Primary outcomes

  1. Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire)

    Time frame: at Baseline, at V2 (26 +/- 2 days)

Secondary outcomes

  1. Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale)

    Time frame: at Baseline, at V2 (26 +/- 2 days)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: MORFEO CR

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 1, 2010
Registry last updated
Jul 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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