NCT00292734

Brief Summary

Primary objective: To show that the combination of Zolpidem + antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

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

January 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

December 6, 2007

Status Verified

December 1, 2007

First QC Date

February 15, 2006

Last Update Submit

December 4, 2007

Conditions

Sleep Initiation and Maintenance DisordersDepression

Outcome Measures

Primary Outcomes (1)

  • To show that the combination of Stilnox+ antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease

Interventions

ZolpidemDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Depressive and dysthimic patients in acute phase of mild to moderate severity
  • Depressive and dysthimic patients suffering from secondary insomnia (DSM IV) recent antidepressant therapy (less than 1 week)

You may not qualify if:

  • Regularly use of sleeping pills in the last 2-3 month
  • Use of any sleeping pils in the last week
  • Insufficient hepatic
  • Myasthenia gravis
  • Proven hypersensivity to Zolpidem
  • Evidence of clinically relevant nervous system disorders (other neurologic/psychiatric diseases associated with depression)
  • History of evidence of alcohol or drug abuse
  • Evidence of clinically relevant cardiovascular, haematologic, hepatic, gastrointestinal, renal, pulmonary or endocrinologic diseases
  • Abnormal snore
  • Work an alternating shift
  • Suffering from periodic leg movement disorder and sleep apnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Budapest, Hungary

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersDepression

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • László Erős, MD

    sanofi-aventis Hungary

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 15, 2006

First Posted

February 16, 2006

Study Start

January 1, 2005

Study Completion

June 1, 2006

Last Updated

December 6, 2007

Record last verified: 2007-12

Locations

HU(1)