Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression

NCT ID: NCT00042575

Last Updated: 2006-07-19

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2002-08-31

Brief Summary

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The Purposes of this Study are to determine:

The safety of duloxetine and any side effects that might be associated with it.

Whether duloxetine can help patients with major depression.

It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.

Duloxetine might not have any good effects for you.

Detailed Description

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Conditions

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Major Depressive Disorder

Keywords

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Sad, blue, lack of energy, depressed, hopelessness, guilt

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Duloxetine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* You must be at least 18 years old.
* You must be diagnosed with major depressive disorder
* You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 8 weeks.

Exclusion Criteria

* You are a woman and are pregnant or breastfeeding.
* You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
* You have a history of alcohol or drug dependence or abuse within the past 6 months.
* You are allergic to the study drug or you have experienced allergic reactions when taking several medications at once.
* You have a serious medical illness.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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Trumbull, Connecticut, United States

Site Status

Lafayette, Indiana, United States

Site Status

Gaithersburg, Maryland, United States

Site Status

Belmont, Massachusetts, United States

Site Status

Omaha, Nebraska, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

Staten Island, New York, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Bellevue, Washington, United States

Site Status

Countries

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United States

References

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Wohlreich MM, Mallinckrodt CH, Prakash A, Watkin JG, Carter WP. Duloxetine for the treatment of major depressive disorder: safety and tolerability associated with dose escalation. Depress Anxiety. 2007;24(1):41-52. doi: 10.1002/da.20209.

Reference Type DERIVED
PMID: 16845641 (View on PubMed)

Other Identifiers

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F1J-US-HMBY

Identifier Type: -

Identifier Source: secondary_id

6475

Identifier Type: -

Identifier Source: org_study_id