NCT00296179

Brief Summary

To demonstrate overall improvement of insomnia in subjects treated with zolpidem tartrate extended-release (Ambien CR) and escitalopram (Lexapro) vs. subjects treated with placebo and escitalopram at 2 months.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
372

participants targeted

Target at P75+ for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Last Updated

July 28, 2008

Status Verified

July 1, 2008

Enrollment Period

1.3 years

First QC Date

February 23, 2006

Last Update Submit

July 25, 2008

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • Efficacy: Patient-reported TST

Secondary Outcomes (1)

  • Difference in relapse rates in patients receiving placebo and patients receiving zolpidem MR during 4 month follow-up period

Interventions

zolpidem tartrateDRUG

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Must experience sleep disturbances at least 3 nights/week, based on historical data
  • Must meet the diagnostic requirements for Major Depressive Disorder
  • Must have QIDS-SR16 score between 6 and 15
  • Must be either newly diagnosed or show symptoms of relapse/recurrence of depression while not on medication
  • Age 21-64, inclusive
  • Women must use a medically acceptable form of contraception (steroidal contraceptive, double-barrier, or intra-uterine device) 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.
  • Subject must be stabilized on all ongoing long-term medication therapy for at least 28 days prior to screening visit.

You may not qualify if:

  • Severity of depressive episode had been rated as "severe" or "severe with psychotic features."
  • History of a suicide attempt or suicidal ideation.
  • History of mania, manic episode or bipolar disease.
  • Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.
  • Use of prescription and non-prescription sedative drugs given for the purpose of sleep induction or to relieve jet lag
  • Any abnormal pre-study laboratory values that require clinical intervention
  • Prior failure to respond to escitalopram therapy for depression
  • Current depressive episode requiring inpatient hospitalization.
  • Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous 28 days.
  • History of drug addiction, alcoholism, or drug abuse.
  • A positive urine drug screen for medication that would interfere with the assessment of the study medication.
  • Known allergy to zolpidem, escitalopram or any of their excipients
  • History of sleep apnea
  • History of myasthenia gravis
  • The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fava M, Asnis GM, Shrivastava RK, Lydiard B, Bastani B, Sheehan DV, Roth T. Improved insomnia symptoms and sleep-related next-day functioning in patients with comorbid major depressive disorder and insomnia following concomitant zolpidem extended-release 12.5 mg and escitalopram treatment: a randomized controlled trial. J Clin Psychiatry. 2011 Jul;72(7):914-28. doi: 10.4088/JCP.09m05571gry. Epub 2010 Dec 28.

    PMID: 21208597DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic 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 24, 2006

Study Start

February 1, 2006

Primary Completion

June 1, 2007

Last Updated

July 28, 2008

Record last verified: 2008-07