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

NCT ID: NCT00296790

Last Updated: 2007-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 372 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2007-02-28

Brief Summary

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).

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

zolpidem tartrate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female between the ages of 21and 64 years, inclusive;

2. 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;

3. Must meet the diagnostic requirements of Generalized Anxiety Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders;

4. Score at least 18 on the Hamilton Rating Scale for Anxiety (HAM-A)

5. Must be either newly diagnosed or show symptoms of relapse during a period of no drug therapy for anxiety.

6. Subject must experience sleep disturbances at least three nights per week, for at least one month prior to study entry, based on historical data.

7. Subject must be stabilized on all long-term medication therapy for at least one month prior to study entry.

EXCLUSION

1. History of Post-Traumatic Stress Disorder;

2. Concomitant Major Depressive Disorder or Bipolar Disorder;

3. Any abnormal pre-study laboratory values that require clinical intervention

4. Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous month.

5. Pregnant or breastfeeding

6. History of drug addiction, alcoholism, or drug abuse

7. Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.

8. A positive urine drug screen for compounds that would interfere with the assessment of a hypnotic.

9. Use of prescription and non-prescription sedative drugs;

10. Prior failure to respond to escitalopram therapy for anxiety

11. The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy.

12. History of sleep apnea

13. History of myasthenia gravis

14. Known hypersensitivity and/or allergy to or previous adverse experience with zolpidem or escitalopram or any of their excipients

15. Subject is currently participating in another clinical trial (or within 28 days of screening).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Principal Investigators

Phyllis Diener

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

PM_L_0167

Identifier Type: -

Identifier Source: org_study_id