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

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Lilly

Status and phase

Completed
Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: Duloxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00042575
F1J-US-HMBY
6475

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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