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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00191685




Registration number
NCT00191685
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
25/07/2006

Titles & IDs
Public title
Duloxetine in the Treatment of Melancholic Depression
Scientific title
Duloxetine in the Treatment of Melancholic Depression: An 8-Week Open-Label Dose Study
Secondary ID [1] 0 0
F1J-AY-HMCZ
Secondary ID [2] 0 0
8163
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder, Major 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - duloxetine

Treatment: Drugs: duloxetine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To generate data to compare the proportion of outpatients with major depressive disorder with melancholic features who responded to duloxetine at a given daily dose after initially not responding to duloxetine 60mg once daily for 4 weeks.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To compare outpatients with major depressive disorder with melancholic features who achieved remission after treatment with duloxetine;Collect data on the safety of duloxetine.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Have a diagnosis of major depression with melancholic features, as defined by
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition [DSM-IV]
criteria.

- Experienced their first episode of major depression prior to age 50.

- Have a HAMD17 total score of less than or equal to 20 at Visits 1 and 2.

- Test negative for a urine pregnancy test at Visit 1 (females).

- Agree to use medically acceptable and reliable means of birth control during the
study, as determined by the investigator (females of child-bearing potential, not
surgically sterilized and between menarche, and one year post-menopausal).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have any current and primary Axis I mood disorder other than MDD, including, but not
limited to, dysthymia, seasonal affective disorder or psychotic depression.

- Have a current episode of major depression that has failed to respond to two or more
courses of antidepressant therapy or, in the judgment of the investigator, meets
criteria for treatment-resistant depression

- Are at serious suicidal risk as determined by the investigator.

- Have a serious medical illness or clinically significant laboratory abnormalities
that, in the judgment of the investigator, are likely to require medication/
intervention/ hospitalization during the course of the study.

- Had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit
2 or potential need to use a MAOI during the study or within 14 days of
discontinuation of study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time(UTC/GMT - 5 hours, EST), or speak with your personal physician. - Paddington
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time(UTC/GMT - 5 hours, EST), or speak with your personal physician. - Everton Park
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time(UTC/GMT - 5 hours, EST), or speak with your personal physician. - Hoppers Crossing
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time(UTC/GMT - 5 hours, EST), or speak with your personal physician. - Nambour
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time(UTC/GMT - 5 hours, EST), or speak with your personal physician. - New Farm
Recruitment hospital [6] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time(UTC/GMT - 5 hours, EST), or speak with your personal physician. - South Port BC
Recruitment hospital [7] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time(UTC/GMT - 5 hours, EST), or speak with your personal physician. - Elizabeth Vale
Recruitment hospital [8] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time(UTC/GMT - 5 hours, EST), or speak with your personal physician. - Richmond
Recruitment postcode(s) [1] 0 0
- Paddington
Recruitment postcode(s) [2] 0 0
- Everton Park
Recruitment postcode(s) [3] 0 0
- Hoppers Crossing
Recruitment postcode(s) [4] 0 0
- Nambour
Recruitment postcode(s) [5] 0 0
- New Farm
Recruitment postcode(s) [6] 0 0
- South Port BC
Recruitment postcode(s) [7] 0 0
- Elizabeth Vale
Recruitment postcode(s) [8] 0 0
- Richmond
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
New Brunswick
Country [5] 0 0
Canada
State/province [5] 0 0
Nova Scotia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the optimal treatment strategy for MDD patients
with melancholic features who do not respond to a standard daily dose. This study will allow
investigators to mimic standard clinical practice. During the first 2 weeks of treatment,
clinical evaluation of individual patient tolerability and efficacy will enable the dose of
duloxetine to be adjusted. Patients allocated to the Flex group may have their daily dose of
duloxetine adjusted in the attempt to elicit a clinical response.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00191685
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries