Escitalopram Combination Comparison Study for Adult Patients With Major Depressive Disorder

NCT ID: NCT00239954

Last Updated: 2012-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Escitalopram

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmacology Research Institute

OTHER

Sponsor Role lead

Principal Investigators

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Jon F. Heiser, MD

Role: PRINCIPAL_INVESTIGATOR

Pharmacology Research Institute

Nader Oskooilar, MD

Role: PRINCIPAL_INVESTIGATOR

Pharmacology Research Institute

Locations

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Pharmacology Research Institute

Los Alamitos, California, United States

Site Status

Pharmacology Research Institute

Newport Beach, California, United States

Site Status

Pharmacology Research Institute

Northridge, California, United States

Site Status

Pharmacology Research Institute

Riverside, California, United States

Site Status

Countries

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United States

Other Identifiers

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PRI#591 & #592

Identifier Type: -

Identifier Source: org_study_id

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