Open-Label Treatment With Duloxetine Hydrochloride Once-D... | NCT00042562

ID	Type	Description	Link
F1J-US-HMBZ

Status Module

Record Verification Date

Jul 2006

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

Dec 2002

Primary Completion Date

Not provided

Completion Date

Dec 2003

First Submitted Date

Jul 31, 2002

First Submission Date that Met QC Criteria

Aug 2, 2002

First Posted Date

Aug 5, 2002Estimated

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

Jul 18, 2006

Last Update Posted Date

Jul 19, 2006Estimated

Description Module

Brief Summary

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.

The safety associated with switching from a medication you may be taking for depression to taking duloxetine.

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.

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

Not provided

Name	Type	Description	Arm Group Labels	Other Names
duloxetine	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

You must be at least 18 years old.
You must have been 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 14 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 had a primary diagnosis of an anxiety disorder within the past 6 months.
You have a history of alcohol or drug dependence or abuse within the past 6 months.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003865	Depressive Disorder, Major
D003244	Consciousness Disorders
D005221	Fatigue

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D019965	Neurocognitive Disorders

Facility	Status	City	State	ZIP	Country	Contacts
		Carlsbad	California		United States

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds