Major Depressive DisorderPhase 4NCT01035073

Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome

A Phase 4 study testing Duloxetine in people with Major Depressive Disorder and Soft Tissue Discomfort Syndrome, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to determine the time course of duloxetine efficacy on the symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort Syndrome(STDS) via use of 24-hour Actigraph™ measures. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Major Depressive Disorder, Soft Tissue Discomfort Syndrome, Pain
What is being tested?: Duloxetine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Apr 2006to May 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

> 17 years old
All races and ethnicity
DSM IV-TR Axis I diagnosis of MDD
Co-morbid STDS
Baseline 17-item Hamilton Depression Rating > 13

Who cannot join

Primary Axis I disorder other than MDD
History of mania or psychosis
Actively suicidal
Required hospitalization
A alcohol or substance abuse or dependence within the preceding 3 months
Pregnant or nursing

Show all 10Show fewer

Unstable medical condition (other than STDS)
Narrow-angle glaucoma
Sensitivity to duloxetine, concurrent antidepressant, tranquilizer, or mood stabilizer use
Hepatic or renal insufficiency

Trial locations and contacts

1 site in 1 country.

United States1 site

Depression Research Unit, University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104-3309

Other trials in United States

About this study

Official title: Functional Change and Efficacy of Duloxetine in Patients With Major Depression and Co-Morbid Soft Tissue Discomfort Symptoms

We hypothesize that there will be a reduction in both MDD and STDS symptoms in MDD patients with co-morbid STDS symptoms. We further hypothesize that there will be a rapid improvement in functional outcome ratings and 24-hour activity in MDD patients with co-morbid STDS symptoms which may occur even before the antidepressant effect is observed.

Conditions: Major Depressive Disorder, Soft Tissue Discomfort Syndrome, Pain
Being tested: Duloxetine
Medical subject headings: Depressive Disorder, Major, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DuloxetineDrug
Also called Cymbalta
30-60 mg daily for 8 weeks

Study groups in NCT01035073
Study group	Role	What they receive
Duloxetine	Experimental	Not described Receives: Drug: Duloxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

24-hour Activity Level
Measured: Baseline and Week One of Treatment

Secondary outcomes (1)

Functional Symptom Questionnaire
Measured: Baseline; Week 6 and Week 8 of Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006May 2009

First posted18 Dec 2009 (estimated)
Study startApr 2006
Primary completionMay 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01035073
Sponsor's protocol ID: F1J-US-X018
Status last verified: Apr 2020
First submitted: 17 Dec 2009
Last updated: 16 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Functional Change and Efficacy of Duloxetine in Patients With Major Depression and Co-Morbid Soft Tissue Discomfort Symptoms
ClinicalTrials.gov ID: NCT01035073
Acronym / sponsor ID: F1J-US-X018
Conditions: Major Depressive Disorder, Soft Tissue Discomfort Syndrome, Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Eli Lilly and Company
Study start: Apr 2006
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 18 Dec 2009 (estimated)
Results: Posted 16 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Duloxetine	Experimental	Drug: Duloxetine

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

> 17 years old
All races and ethnicity
DSM IV-TR Axis I diagnosis of MDD
Co-morbid STDS
Baseline 17-item Hamilton Depression Rating > 13

Key exclusion criteria (10 listed)

Primary Axis I disorder other than MDD
History of mania or psychosis
Actively suicidal
Required hospitalization
A alcohol or substance abuse or dependence within the preceding 3 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DuloxetineAlso: Cymbalta30-60 mg daily for 8 weeks	Drug	Duloxetine

Primary outcome

24-hour Activity Level
Time frame: Baseline and Week One of Treatment

1 secondary outcome

Functional Symptom Questionnaire
Time frame: Baseline; Week 6 and Week 8 of Treatment

Results and safety

Results posted to the registry on 16 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Duloxetine	0	0

Primary outcome: 24-hour Activity Level

Time frame: Baseline and Week One of Treatment

Population analysed: The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 Years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Duloxetine	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Data is unavailable for the following reasons: investigator has succumb to serious health conditions preventing him from entering data, and study team members no longer work for the university and cannot be reached to input data despite efforts.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Depression Research UnitLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jay D Amsterdam, MD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Duloxetine in people with Major Depressive Disorder and Soft Tissue Discomfort Syndrome, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour Activity Level (time frame: Baseline and Week One of Treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01035073.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.