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

NCT00296790 | Completed Phase 4

• 1 other identifier: PM_L_0167
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Evaluate safety and hypnotic efficacy of zolpidem tartrate extended release vs. placebo in treatment of insomnia associated with Generalized Anxiety Disorder when used concomitantly with escitalopram

Secondary Outcomes (1)

• To show that treating insomnia from beginning of SSRI (Selective Serotonin Reuptake Inhibitor) treatment for anxiety results in improvement in quality of life and possibly greater response to anti-anxiety therapy

Interventions

zolpidem tartrate DRUG

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Phyllis Diener

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 27, 2006
• Study Start: February 1, 2006
• Study Completion: February 1, 2007
• Last Updated: October 12, 2007

Record last verified: 2007-10

Locations

US (1)