Study of Escitalopram in Adult Patients With Major Depres... | NCT00108979

Studies
Study of Escitalopram in Adult Patients With Major Depressive Disorder

NCT00108979

Sponsor

Forest Laboratories

Status

Completed

Last Update Posted

Mar 5, 2012Estimated

Enrollment

240

Phase

Phase 3

Conditions

Major Depressive Disorder

Interventions

Escitalopram

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 2005

Primary Completion Date

Jul 2006Actual

Completion Date

Jul 2006Actual

First Submitted Date

Apr 21, 2005

First Submission Date that Met QC Criteria

Apr 21, 2005

First Posted Date

Apr 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2012

Last Update Posted Date

Mar 5, 2012Estimated

Description Module

Brief Summary

Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to evaluate the efficacy, safety, and pharmacoeconomics of escitalopram and an active comparator in patients with major depressive disorder.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240

Name	Type	Description	Arm Group Labels	Other Names
Escitalopram	Drug

Measure	Description	Time Frame
Montgomery Asberg Depression Rating Scale (MADRS)

Measure	Description	Time Frame
Hamilton Depression Rating Scale (HAMD)

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southwest Health, Ltd.		Phoenix	Arizona	85016	United States
Summit Research Network

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21438794	Derived	Signorovitch J, Ramakrishnan K, Ben-Hamadi R, Yu AP, Wu EQ, Dworak H, Erder MH. Remission of major depressive disorder without adverse events: a comparison of escitalopram versus serotonin norepinephrine reuptake inhibitors. Curr Med Res Opin. 2011 Jun;27(6):1089-96. doi: 10.1185/03007995.2011.567255. Epub 2011 Mar 28.

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572