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Clinical Trials/NCT00239954
NCT00239954
Unknown
Phase 3

Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

Pharmacology Research Institute1 site in 1 countryMarch 2005
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ConditionsMajor Depressive Disorder
DrugsEscitalopram

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Pharmacology Research Institute
Locations
1
Primary Endpoint
Montgomery Asberg Depression Rating Scale (MADRS)
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the effectiveness, safety and tolerability of an escitalopram combination treatment compared to single treatments, and to placebo in patients with major depressive disorder.

Detailed Description

Both active drugs being tested, alone and in combination, in this study are currently available antidepressants. However, the doses used in this study are lower than the standard approved doses.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pharmacology Research Institute

Eligibility Criteria

Inclusion Criteria

  • •Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder
  • •The patient's current depressive episode must be at least 12 weeks in duration.

Exclusion Criteria

  • •Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
  • •Patients who currently meet DSM-IV criteria for : a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder.
  • •Patients who are considered a suicide risk.
  • •Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of seizure.

Outcomes

Primary Outcomes

Montgomery Asberg Depression Rating Scale (MADRS)

Secondary Outcomes

  • Hamilton Depression Rating Scale (HAMD)

Study Sites (1)

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