Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro)

Completed · Phase 4

Conditions studied: Insomnia

In brief

A comparison of Zolpidem Tartrate Extended-Release (Ambien CR)vs. Placebo in the Treatment of Insomnia Associated with Generalized Anxiety Disorder (GAD) when Used Concomitantly with Escitalopram (Lexapro - antidepressant).

Key facts

Study ID

NCT00296790

Run by

Sanofi

People needed

372

Starts

2006-02-01

Expected to finish

2007-02-01

Last updated by the study team

2007-10-12

Who can join

Age: 21 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female between the ages of 21and 64 years, inclusive;
• Women must use a medically acceptable form of contraception during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization;
• Must meet the diagnostic requirements of Generalized Anxiety Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders;
• Score at least 18 on the Hamilton Rating Scale for Anxiety (HAM-A)
• Must be either newly diagnosed or show symptoms of relapse during a period of no drug therapy for anxiety.
• Subject must experience sleep disturbances at least three nights per week, for at least one month prior to study entry, based on historical data.
• Subject must be stabilized on all long-term medication therapy for at least one month prior to study entry.
• EXCLUSION
• History of Post-Traumatic Stress Disorder;
• Concomitant Major Depressive Disorder or Bipolar Disorder;
• Any abnormal pre-study laboratory values that require clinical intervention
• Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous month.
• Pregnant or breastfeeding
• History of drug addiction, alcoholism, or drug abuse
• Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.
• A positive urine drug screen for compounds that would interfere with the assessment of a hypnotic.
• Use of prescription and non-prescription sedative drugs;
• Prior failure to respond to escitalopram therapy for anxiety
• The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy.
• History of sleep apnea
• History of myasthenia gravis
• Known hypersensitivity and/or allergy to or previous adverse experience with zolpidem or escitalopram or any of their excipients
• Subject is currently participating in another clinical trial (or within 28 days of screening).

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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